JP2008514253A - Additional improvements in powder compaction and enrobe - Google Patents

Abstract

  The present invention relates to an apparatus and method for forming a compacted powder slag (7) coated with a film. In the device of the present invention, for example, the drug powder (6) uses vacuum or differential pressure around the surface of the powder (6) to be consolidated, and preferably mechanically compacts the powder (6). And forming a material, preferably a hydroxypropylmethylcellulose film (8), to produce a compacted, enrobed, consolidated powder slag (7).

Description

  The present invention relates to such compacted powders which are enrobed by powders such as pharmaceuticals, vitamins, dietary supplements and the like and non-gelatin films such as biodegradable and / or water soluble films such as hydroxypropylmethylcellulose (HPMC). The present invention relates to compaction of powder containing body. The present invention is applicable to all relevant dosage forms, including tablets and capsules, and for simplicity, all such forms are tablets.

  Tablets are a common type of dosage form, and various means have already been tried to improve their properties. Current methods of coating tablets, such as drug tablets, spray the tablets with low molecular weight HPMC grades and use the Acera or Pan coater to give a uniform, smooth but opaque and low gloss surface layer. Including. Tablets can be embossed on the surface. However, this method of coating tablets is time consuming and requires a high level of expertise in order to produce satisfactory results. Complex problems related to production, such as tablet bonding, where two tablets are bonded together during a spray coating operation are common. In addition to these problems, it is necessary to compact the tablets at a relatively high pressure so that they do not collapse during the coating process. Such a high level of compaction can adversely affect the degradation and dissolution rate of the active ingredient contained within the capsule, for example, delayed release of the drug to the patient, Dissolves slowly in.

  An alternative to spray or pan coating uses two-piece hard capsules. These are produced by a dipping process, typically HPMC solutions are used to interlock and encapsulate the encapsulated capsules to produce a half shell. These capsules are typically opaque but glossy and cannot take the form of relief because they interfere with the overlap interlocking process. The nature of the capsule indicates that there are always voids above the powder filling level. Furthermore, it is not possible to compact the powder into these tablets, which limits the amount of powder that can be encapsulated. Thus, such a lack of compaction may actually reduce the amount of drug placed in the capsule, for example. As a result of gaps in the capsule and insufficient compaction of the powder contained in the capsule, it is inevitable that the capsule becomes larger than necessary.

After the manufacture and / or sale of two-piece hard capsules, the capsules can be easily and fraudulently interfered, which halves the capsule, modifies the contents, and divides the two halved capsules It has also been found that it is possible to revert to one and avoid any apparent changes in the appearance of the capsule that would make the user feel that something is wrong with the capsule. This means that it may be difficult to detect capsules whose contents have been tampered with. HPMC and some other non-gelatin materials are suitable for ingestion by humans, so delivery capsules with a gelatin wall are possible alternatives to gelatin-based capsules, such as the accuracy of pharmaceuticals and dietary supplements. There is potential use as an ingestible capsule for delivering metered doses. Conventional tablets are already enrobed. See for example WO 02/098394.
International Publication No. 02/098394

According to one aspect of the present invention, an apparatus for forming a film on a dosage form is realized, the apparatus comprising:
A platen for directly holding the oral dosage form from which the film is formed;
At least one film supply arrangement;
At least one film conditioning unit (also referred to as a “preconditioning unit”);
In use, the barrier comprises a barrier plate disposed between the film conditioning means and the target tablet to protect the oral dosage form from the effects of film conditioning.

According to another aspect of the present invention, there is provided a method of forming a film directly on a dosage form, the method comprising:
Providing a platen for directly holding the oral dosage form from which the film is formed;
Providing a film from a film supply arrangement on a barrier plate, the barrier plate being disposed between the film conditioning unit and the oral dosage form from which the film is formed;
Adjusting the film,
Forming a film directly on the oral dosage form.

According to another aspect of the present invention, an apparatus for forming a film-coated dosage form is realized, the apparatus comprising:
A platen comprising a substantially flat platen surface comprising a plurality of locations for receiving dosage forms;
A film conditioning unit that can be arranged to condition the film to impart properties to the film that allow the film to be formed on the dosage form at the location;
A barrier disposed between the platen surface and the film conditioning unit and having an opening through which to form a film when adjusted.

According to another aspect of the present invention, there is provided a method for forming a film-coated dosage form comprising:
Providing multiple dosage forms in multiple locations to contain the dosage forms;
Providing a film formed on the dosage form;
A barrier disposed between the film and the dosage form, the barrier comprising an opening through which the film is formed directly on the dosage form;
Adjusting the film to impart properties that allow it to be formed;
Forming a film on the dosage form through the barrier.

According to another aspect of the present invention, an apparatus for forming a film-coated dosage form is realized, the apparatus comprising:
One or more platens movable between a plurality of stations each carrying out a plurality of steps of an enrobing process holding a dosage form;
A station where a conditioned film is formed on a target associated with the platen;
One or more film lifters operable to separate the scrap film from the platen after the forming step.

According to another aspect of the present invention, there is provided a method for forming a film-coated dosage form comprising:
Providing a platen for holding the dosage form;
Adjusting the film and forming it on a target associated with the platen using vacuum and / or pressure to form an enrobed product;
Cutting the enrobed product from the film, leaving a waste film,
Separating the waste film from the platen after the forming step using one or more film lifters operable to push the waste film away from the platen;
Moving the platen to another one of the plurality of stations.

According to another aspect of the present invention, an apparatus for forming a compacted powder slag coated with a film is realized, the apparatus comprising:
A consolidation device capable of a first enrobe step in which powder is consolidated into a film formed in a plurality of pockets to provide a plurality of partially enrobed powder slugs;
An enrobing device capable of a second enrobe process in which the partially enrobed powder slag is enrobed to produce a fully enrobed powder slag;
A transfer and cutting tool comprising a cutting device and a transfer gasket is provided.

According to another aspect of the present invention, there is provided a method for forming a compacted powder slag coated with a film, the method comprising:
Performing a first enrobe step in which the powder is consolidated into a film formed in a plurality of pockets to provide a plurality of partially enrobed powder slugs;
Performing a second enrobe step in which the partially enrobed powder slag is enrobed to produce a fully enrobed powder slag in the form of a film web;
Before cutting the engraved powder slag from the film web using a combined device of the cutting device and transfer tool and moving the cutting device onto the slag to press fit the slag with the transfer component of the tool, A cutting device is cut into engagement with the film web to cut the fully enrobed powder slag from the film web;
Transferring the fully enrobed powder slag.

According to another aspect of the present invention, a combined cutting and transfer tool for cutting a tablet from a scrap film web and holding the tablet for transfer is realized, the tool comprising:
A cutting device comprising a plurality of cutting device holes extending between the cutting surface and the non-cutting surface;
A transfer gasket provided near the non-cutting edge of the cutting device and having a plurality of press-fit holes at locations linked to the holes in the cutting device.

In accordance with another aspect of the present invention, there is provided a method of cutting and transferring tablets from a film without using a combined cutting and transfer tool having a transfer gasket that follows the cutting device in the direction of cutting.
Placing the combined cutting device and transfer tool such that the cutting device hole of the cutting device tool is in cutting engagement with the scrap film web for cutting the tablet from the web;
Continuing to move the compound cutting device and transfer tool in the direction of cutting until the tablet is press-fitted into the press-fit hole in the transfer gasket;
Transporting the tablets.

According to another aspect of the invention, a method of ironing a plurality of enrobed dosage forms is provided, the method comprising:
Placing a transfer arm and holding a plurality of enrobed dosage forms in a press-fit gasket of the transfer arm;
Positioning the transfer arm adjacent to an ironing tool having a plurality of press-fit ironing orifices;
Activating a finger pusher to simultaneously push the plurality of dosage forms from the press-fit position in the gasket to the press-fit position in the ironing tool;
Considering a predetermined time so that the plurality of dosage forms are heated in the ironing tool;
Activating the finger pusher to simultaneously push the plurality of ironed dosage forms from the ironing tool to a collocation position.

According to another aspect of the present invention, an apparatus for forming a compacted powder slag coated with a film is realized, the apparatus comprising:
A compaction device capable of performing a first enrobe step in which the powder is consolidated into a film formed in a pocket to provide a partially enrobed powder slag;
An enrobe apparatus capable of performing other enrobe steps in which the remainder of the partially enrobed powder slag is enrobed;
A jet sprayer operable to apply fluid to the powder slag.

According to another aspect of the present invention, an apparatus for forming a compacted powder slag coated with a film is realized, the apparatus comprising:
A powder reservoir;
A compacting device capable of compacting the powder in a film formed in a pocket to produce a partially enrobed powder slag;
Operable to deliver powder between the powder reservoir and the compaction device, recover the powder from the powder reservoir, pre-consolidate the powder and then transfer to the compaction device And the pre-consolidation by the powder dozer is performed at a lower pressure than the consolidation by the compaction device.

  In another aspect of the present invention, an apparatus comprising a platen having a pocket for forming a compacted powder slag coated with a film, receiving a vacuum forming film in the pocket, and receiving the powder; Mechanical means comprising a front surface with a recess and a compression piston with a square edge around the front surface for compacting the powder.

  In one embodiment, the pocket comprises a base formed by a concave piston front surface and a lower piston having a square edge around the front surface. The front surface of the lower piston further includes at least two apertures for evacuating the pocket and forming the film in a vacuum. The platen further includes an aperture for creating a vacuum between the platen and the film. Apertures are lined up in the platen along the periphery of the pocket. The platen further includes a recessed surface that defines a raised edge that forms the periphery of the pocket. The diameter clearance between the compression piston and the pocket is a fraction of the film thickness. The diameter clearance between the compression piston and the pocket is at most 35 micrometers. The diameter clearance between the lower piston and the pocket is a fraction of the film thickness. The diameter clearance between the lower piston and the pocket is at most 25 micrometers. The platen is further lined with rows of pockets. Means for temporarily holding for adjustment and adjusting the film for heating comprising a heated plate having a surface with a plurality of aligned apertures for creating a vacuum between the heated plate and the film Can be provided in the apparatus. The apparatus can further comprise a gasket for receiving and holding the compacted powder slag for transporting and discharging the compacted powder slag to a desired location. The gasket can include an aperture having a receiving side and an outlet side for receiving the compacted powder slag, the receiving side having a larger diameter than the outlet side.

  Another aspect of the invention comprises a film preconditioner for forming a compacted powder slag coated with a film and temporarily holding and heating the film, the film preconditioner being heated. An apparatus comprising a heated plate having a surface with a plurality of apertures arranged to create a vacuum between the plate and the film, and receiving the preconditioned film in a pocket under vacuum conditions; A platen with a pocket for receiving the powder and mechanical means for compacting the powder into the pocket.

  Another aspect of the present invention is to form a compacted powder slag coated with a film comprising a platen comprising a plurality of aligned pockets for receiving a vacuum forming film in the pocket, the pocket comprising a powder A device with at least one aperture close to the pocket so that the platen can create a vacuum between the platen and the film, and a mechanical for compacting the powder into the pocket Means. In one embodiment of the invention, the apertures are lined up in the platen along the periphery of the pocket.

  One aspect of the present invention forms a compacted powder slug coated with a film comprising a platen comprising a plurality of aligned pockets for receiving a vacuum formed film in a pocket for receiving powder, each of the pockets A platen with a concave surface between a plurality of raised end sections surrounding the device, mechanical means for compacting the powder into the pocket, and cutting the supported film And a cutting sleeve movable to interfere with the raised end section.

  In one embodiment, the apparatus can further comprise a turntable for holding and transferring the platen during processing. The turntable can comprise four platens. The apparatus can further include a vacuum generation function for cleaning the platen.

  Another aspect of the present invention comprises a device according to any one of the preceding claims, further comprising a dozer for dispensing powder into the pocket and a dosing unit, the dozer for holding the powder. A powder hopper and a dosing head having a dosing tube for holding the powder from the powder hopper and transferring the powder to the pocket are provided. The dosing head can be provided with a tamping pin in the tube for pre-compacting the powder in the dosing tube and transferring the powder from the tube to the pocket. In one embodiment, the device may comprise a dosing unit having mechanical means for compaction, and a dosing sledge for receiving the powder from the dosing tube of the dosing head and dispensing the powder into the pocket. Is movable from the filling position to the administration position.

  Another aspect of the invention comprises an apparatus comprising a platen having a pocket for forming a compacted powder slag encapsulated with a film, receiving a vacuum forming film in the pocket, and receiving the powder. An administration means for placing the powder at a position suitable for compaction of the powder in a pocket having the vacuum forming film of 1 together with the powder, a compacting mechanical means for compacting the powder, and a platen And a turntable for transferring the platen from one station to the other during processing. One station attaches a film into the platen pocket and compacts the powder by compacting the powder. Partly enrobed, the other station applies a second vacuum forming film onto the partly enrobed consolidated powder and the slag is completely covered with film Over to computing.

  In one embodiment, the dosing means places the powder in a position near the pocket that is suitable for compacting the powder in a pocket having a first vacuum forming film with the powder. The dosing means can dispense the powder into the pocket having the first vacuum forming film.

  In one embodiment, the apparatus may include a vacuum generation function for cleaning the platen and other stations for cleaning the platen. The number of platens in the turntable may correspond to the number of stations in the device. The turntable may comprise four platens for processing in other embodiments. The apparatus can comprise means for isolating the compaction pressure from the turntable assembly during the consolidation.

  In another aspect of the invention, an apparatus comprising a platen having a pocket for forming a compacted powder slag coated with a film, receiving a vacuum forming film in the pocket, and receiving the powder; Mechanical means for compressing the compressed powder slag into the pocket and a gasket for receiving and holding the compacted powder slag for transporting and discharging the compacted powder slag to a desired location. The gasket can include an aperture having a receiving side and an outlet side for receiving the compacted powder slag, the receiving side having a larger diameter than the outlet side. The gasket can have a plurality of apertures for receiving a plurality of consolidated powder slags.

  One aspect of the present invention relates to a novel method for compacting and enrobing powders to produce capsules with enhanced properties.

  Non-gelatin film layers are tablet-shaped pockets thermoformed under the influence of heat and / or vacuum and / or pressure. A predetermined amount of powder is dispensed into the film-forming pocket and compressed into a tablet shape with the aid of, for example, one or more pistons. Partially enrobed “soft” tablets are made from this process and then a second event with a tablet bulge above the platen that allows the rest of the compressed tablets to be enrobed by the second film Fully enrobed by the column. A suitable tablet-shaped pocket can be formed, for example, using a pair of pistons that are slidable within a cylinder, such pistons can further remove unwanted excess film from (partially) enrobed tablets. It has the advantage that a pinch point can be formed between the platen and the top of the cylinder to help cut.

  One of the objects of the present invention is to produce capsules with an anti-tampering function.

  Another object of the preferred embodiment is to produce a powder-filled capsule in which the powder is enrobed with a material that may or may not form a “skin tie trap”.

  Another object of the preferred embodiment is to produce capsules with a high gloss surface that can employ a lower bulge, eg, to identify drug tablets.

  Another object of the preferred embodiment is to produce capsules with flanges that are hardly discernable.

  Other objectives of the preferred embodiment include a variety of dosage forms that have not previously been made or practical to use due to the nature of the processes involved and the characteristics of the product produced. Enabling the production of dosage forms of any shape and size.

  Another object of the preferred embodiment is high speed plasticized with powders or other flowable solid materials in advantageous states of compaction and / or composition and / or pharmaceutical grade materials with advantageous properties To produce capsules containing capsule encapsulation media that are pharmaceutical grade films that are soluble or dissolvable (by control).

  Another object of the preferred embodiment is to produce a capsule that, by its nature, is easy to swallow and can be more easily delivered to the desired site where the active ingredient is most conveniently released.

  Another aspect of the present invention is a powder compaction for producing a powder compacted slag that can be enrobed, for example, to produce capsules with enhanced degradation and dissolution properties over conventional tablets. It is a method.

  Other aspects of the invention can perform at least the same functions as conventional coated tablets, but the conventional tablet compression and coating process is a method of producing capsules that is replaced by a single powder enrobe process. is there.

  Another aspect of the invention is a method for producing capsules by enrobing a powder, which, due to the nature of the capsules produced, can eliminate some auxiliary ingredients required in conventional tablet production. For example, ingredients in tablets added for structural integrity can be omitted, although the active ingredient is in a relatively loosely compacted powder form and encapsulated in a film And such films now safely package powders / components, thus providing integrity and forming individual effective dosage forms. As explained above, the ingredients contained in the tablet that are designed to disperse and break up the tablet when it reaches the delivery site can be omitted, but it can be dispensed with in a capsule according to the invention. The active ingredient is not compacted or at least less compacted than conventional tablets, and in this way the compaction is such that once the capsule film is at the site of delivery, for example. This is because once dissolved, the active ingredient can be easily released and dispersed.

  Another aspect of the present invention is a compacted process comprising vacuum forming a film in a pocket and compacting a powder in the pocket, resulting in the formation of a partially encapsulated powder slug in the pocket. A method is provided for enrobing a powder. A second film is vacuum formed on the powder slag and the powder slag is completely enrobed to form individually consolidated powder-filled capsules suitable for use as a dosage form.

  In yet another aspect of the present invention, a method is provided for enrobing a compacted powder using one or more films to form a compacted powder-filled capsule, provided that the compaction used is The films forming the walls of the powdered powder-filled capsules overlap each other.

  In another aspect of the invention, the level of compaction of the compacted powder is less than that required to meet industry standards for compacted individual powder slugs described as tablets. A method is provided for forming and / or enrobing a structured slag.

  In practicing the method of the present invention, the film is deformed to fit the pocket and the outer surface of the compacted powder slag, and the film is actually encapsulated by enveloping around the powder slag. Form. A vacuum chamber or vacuum bed apparatus where the film and powder are placed in a suitably shaped support and exposed to a vacuum (or substantially low pressure) condition is modified and used for this purpose. Can. Such an apparatus can be based on a commercially available vacuum vessel or vacuum bed apparatus, modified as appropriate. Due to the vacuum forming technique, the compacted powder is completely encapsulated and encapsulated in a film, and the capsule contains the compacted powder, such capsules are now commercially available, such as conventional tablets. Has improved controllable properties over dosage forms.

  The compacted powder is typically subjected to pressures in the range of 5-15 megapascals, without limitation. Examples of compacted and enrobed powders include paracetamol, ibuprofen, sorbital, and multivitamins. Other powder fillers include antacids, anti-inflammatory drugs, antihistamine antibiotics, and anticholesterol drugs.

  The film must be a material with sufficient flexibility and plasticity that can be vacuum formed, suitable for human consumption. Some film materials have suitable properties in the natural state, but usually the film material needs to be pretreated so that it can be vacuum formed. For example, the film material may need to be exposed to a solvent therefor, for example, some grades of polyvinyl alcohol (PVA) after applying a small amount of water to the surface or when exposed to high humidity conditions. Form a vacuum. A more generally preferred method is to use a film of thermoplastic material (ie, a material that can be deformed when heated) and soften the film with heat prior to being thermoformed by exposure to differential pressure. To the state. Some embodiments contemplate applying a vacuum and / or positive pressure to generate a differential pressure. Suitable thermoplastic materials are modified cellulosic materials, in particular hydroxypropylmethylcellulose (HPMC) and hydroxypropylcellulose (HPC), polyvinyl alcohol (PVA), polyethylene oxide (PEO), pectin, alginate, starch, and modified starch, In addition, protein films such as soy and whey protein films are included. The currently preferred film material is HPMC. Suitable film materials are currently available.

  When using a thermoplastic film, the film is typically heated prior to application to a pocket or compacted powder slag, and the film is placed in a deformable state that has been softened with heat. This can be accomplished by exposing the film to a heat source, such as an infrared heater, infrared lamp, heated plate, hot air source, and the like. The described process can use a range of temperatures, but, for example, if a film of different thickness can be used for the first and second films in the process, use a first film forming temperature of about 150 ° C. However, a temperature in the range of about 70-80 ° C. can be used in the second film formation stage.

  In the enrobe process, the film can be overlapped by at least 1.5 mm to 2 mm. The compacted powder slag can preferably have a sidewall height of about 3 mm and the film can be overlaid to substantially completely cover the sidewall region.

  The film material may be optionally colored in the form of food pigments such as, for example, FD and C yellow number 5, and / or optional flavors such as sweeteners, and / or optional textures in a known manner. Can have.

  The film material typically includes a plasticizer to impart the desired flexibility to the film in a known manner. Materials used as plasticizers include alpha hydroxy acids such as lactic acid and salts thereof, maleic acid, benzyl alcohol, certain lactones, diacetin, triacetin, propylene glycol, glycerin, or mixtures thereof. A typical thermoplastic film formulation is 72-77 wt.% HPMC and 28-23 wt.% Plasticizer. Preferably, the film formulation is HPMC 74% by weight and plasticizer 26% by weight.

  The film suitably has a thickness in the range of 20 to 200 microns, conveniently in the range of 50 to 100 microns, for example about 80 microns, suitable film thickness depending on the size and form of the tablet Depends on several factors including. Different thickness films can be used, for example, a thicker film, for example 125 microns thick, can be used in the first stage of the enrobe process, and thinner, for example 80 microns thick The film can be used in the second stage of the enrobe process.

  Due to the nature of the film forming process according to the invention, under certain circumstances, for example, if the powder to be consolidated contains particles that can puncture the film under consolidation. It may be advantageous to form a film in the pocket that is thicker than the film covering the rest of the powder slag that has been formed (second phase and final phase of the compacted powder enrobe). Such thickness differences result in some advantageous structural features in the resulting capsules, which are generally rugged and can be safely stored and handled ( Generally, the film on the capsule is thick), such capsules are relatively weak, thin film small, which can result in immediate release properties due to a thin film wall that dissolves faster when exposed to a given solvent. Has an area (window). The difference in film thickness that is advantageous for forming capsules with different thickness walls can be adjusted to, for example, a 70/90 micron film, and its contents are passed through a rugged but thin film window. Capsules that release quickly can be produced.

  Thus, different thickness films can be used in the enrobe process; other examples include thicker films, films up to 200 microns, films up to 70 microns, such as films preferably 125 microns thick, Although it can be used in the first stage of the enrobe process, a thinner film, a film up to 125 microns, a minimum of 50 microns, for example, preferably 80 microns, is used in the second stage of the enrobe process. Can be used.

  When making a plurality of encapsulated compacted powder slags, the spacing between the compacted powder slags can be important. If the compacted powder slag is placed too densely, the film will be completely thermoformed and not matched. For example, it has been found that good results are obtained if the spacing between adjacent consolidated powder slags is about 4 mm, and the film begins to curve away from the sides of the consolidated powder slag. The vertical side walls of the powder slag previously compacted at a distance of about 2 mm can be completely taken.

  In the method of thermoforming multiple products enrobed using vacuum, the difference in driving force available to deform the film is limited to atmospheric pressure (1 Bar). By working with positive pressure alone or in combination with positive pressure to increase the differential pressure on the film surface, the film can be quickly deformed to have a deeper cross section and / or to reduce the spacing between adjacent products Narrow adjacent pockets can be formed. Furthermore, by adding heated compressed air, the cooling effect of the thermodynamic expansion of the compressed gas can be minimized.

  According to one aspect of the invention, the method involves effectively forming an overlapping coating divided into half of the film on the compacted powder slag. This method preferably includes first forming a film in the pocket and then consolidating the powder slag into the film backing pocket, thereby effectively forming a substantial portion of the powder slag within the formed film. The remaining film material that is not coated with the compacted powder slag, for example by cutting, is then coated / encapsulated in a partial capsule, and then half of the compacted powder slag is coated with two Overlapping portions of the coating join together to form a sealed complete enclosure for the slag, again with removal of the remaining excess film material that is not coated on the slag. Adhesive must be applied between the overlapping film coating and the surface of the film layer, for example, to ensure an effective seal between them, and the resulting capsule must be tamper-proof it is conceivable that. The ink jet formulation is preferably a solvent rather than a diluted film. This is applied in a sufficient amount to partially dissolve the surface layer of the film. The presently preferred formulation is 62% benzyl alcohol, 31% denatured ethyl alcohol, 5% potassium acetate and 2% DI water. In other embodiments, the adhesive is conveniently the same composition as the film, but the plasticizer contains a significant percentage, for example, 93% to 98% plasticizer, resulting in a low viscosity material. ing. The adhesive can be applied using, for example, a roller or a spray. The composition by weight percent of another exemplary adhesive formulation is 4% HPMC, 77% lactic acid, 19% water. Consolidated powder slugs and capsules are conveniently provided with a cylindrical side wall portion, with two half coatings overlapping on this side wall. Circularly symmetrical tablets with circular cylindrical side walls are very common, but again, other forms including generally cylindrical side walls, such as generally oval and oval, are known. It has been.

  It may also be advantageous or desirable to apply an adhesive such as that described above to the surface of the compacted powder slag prior to the final stage of coating to promote adhesion of the second part of the film. In some cases. Again, this can be achieved, for example, by using rollers, sprays and the like.

  Multiple tablets arranged in an array may be convenient to coat simultaneously using a reasonably large sheet of film material.

  Embodiments of the present invention will be further described, by way of example only, with reference to the accompanying drawings only.

  The drawing shows the various stages of the powder compaction / enrobe process.

FIG. 1 shows the basic mechanism of powder compaction and enrobe through step a-1.
a. The first film (1) is placed on the platen (2). The lower piston (3) slidable in the cylinder (4) comprises a vacuum port (5).

  b. The film (1) is completely pulled down into the cylinder (4) by the vacuum generated by the vacuum port (5), and the film (1) further rests on the top of the lower piston (3) to form a pocket shape. To do.

  c. A certain amount of powder (6) is introduced over the pocket of the film, and the upper piston (9) moves down towards the lower piston (3), compressing a certain amount of powder (6). .

  d. The compacted powder slag (7) is obtained as a result of completion of step c.

  e. The film is cut by the introduction of a cutting tool (10) to form an isolated semi-enrobe slag of compacted powder. Although this figure shows another cutting tool, in a preferred embodiment, a compacting piston is used to compact the powder and punch the film, as will be described in more detail below. .

  f. The lower piston (3) begins to move upward, which further pushes the compacted powder slag (7) upward.

  g. The lower piston (3) rests and positions the compacted powder slag (7) on the platen (2).

  h. The second film (8) is introduced onto the platen (2) and further stretched loosely onto the compacted powder slag (7).

  i. A second vacuum is applied and drawn around the upper portion of the compacted powder slag (7) in close relation to the upper portion and the second film (8 ) Wraps around the upper part of the compacted powder slag (7).

  j. The cutting tool (12) comes down and trims excess unwrapped film from the powder slag (7).

  k. The fully enrobed powder slag is discharged from the cylinder (4) by further upward movement of the lower piston (3) and the loose end of the film is ironed and sealed by the iron (13).

  l. A fully enrobed tablet with an ironed seam is shown. FIG. 2 shows a modification of the basic process described in FIG.

  Steps a1 and b1 show a second pre-formed film pocket, which is a powder in which the second vacuum forming pocket (14) is partially enrobed as shown in step f of FIG. Formed by being lowered onto a platen just above the body slug. When the opposing film pockets are in place, the lower piston (3) moves upwards, thereby pushing the consolidated partially enrobed powder slug further upwards, a second preforming Place in the cavity of the film pocket, thereby capping the partially enrobed powder slug to form a fully enrobed capsule enrobed by the two pockets of the film. The capsule is then released, trimmed and ironed as already described.

  FIG. 3 shows another variation of the basic process described in FIG.

  Step a2 shows the powder slag as in step f of FIG. 1, and a second pre-formed film pocket is introduced as in FIG. 2, but this time the second shallow vacuum formation. The steps a2-d2 which are shallow pockets formed by the pocket (15) and only coat the upper part of the powder slag and form a seal around the edge of the cylindrical part of the powder slag are revised. Process. This process results in capsules with different types of seals that give the capsules different properties.

  FIG. 4 shows another variation of the process described in FIG.

  However, the basic process is essentially replicated to form a capsule containing two different half doses of powder. The basic process as described in FIG. 1 is duplicated and executed up to step f, which is basically steps a3 to c3 in FIG. The main difference in this respect of FIG. 4 is that the two opposing pockets filled with the compacted powder (16, 17) are half the depth, the upper part of the powder slag is not round, In that it is flat. Step c3 can include placing an intermediate film on the surface of the half slag. Steps d3-f3 show that the two half slugs are combined to form a single capsule of two parts. Step g3 shows the compartmented capsule. The advantage is that at least two separate dosages of the active ingredient can be incorporated into one capsule, perhaps under different compaction pressures. This provides additional flexibility and options for implementing new dosage forms.

  In some of the processes described, powders with varying levels of consolidation by controlling the amount of powder used and / or carefully positioning the cooperating pistons in the consolidation process It is possible to facilitate the formation of slag. As already explained, these various levels of compaction are possible in the powder slag because the slag is enrobed in the film, and this film enrobe is used to provide a convenient stability. The slag can be given the necessary integrity to be able to function as a dosage form. The process and apparatus can be modified to produce capsules with a variety of properties that have advantages over conventional tablets and conventional capsules already known in the art. For example, a capsule according to one embodiment of the present invention comprising a powder with low compaction can have a very advantageous immediate release, eg suitable for a fast-acting analgesic, and the film can be quickly passed through the digestive tract. Designed to be relatively painless, smooth / flexible to move to the intended drug delivery site, and can be designed to dissolve at or near the intended drug delivery site. Capsule contents can be designed to be compressible and fluid, can be pushed to fit the shape of the tight part of the passageway, and can continue to move to the digestive tract with less obstruction Thus, the capsule can be bent and / or compressed as it passes through the human body, so that the lower the powder density in the capsule, the smoother the movement of the capsule in the digestive tract. Such dosage forms may be difficult for the patient to swallow, are painful or restricted in the gastrointestinal tract, or have some other reason that requires the dosage form to be more fluid and less aggressive to the body It is particularly useful in some cases.

  The following methods are shown for illustrative purposes and are not intended to limit the invention in any way.

[Example 1]
the expendables:
Film 1—plasticized with 15.25% lactic acid, 10% triethyl citrate, and 1% processing aid microcrystalline cellulose in the general region of 125 microns thickness, or more preferably about 120 microns thickness. HPMC.

  Film 2 is substantially the same as film 1. In some embodiments, the thickness of the film 2 may be thinner. The thickness may be in the 80 micron thick region, but more preferably is about 100 microns.

  Adhesive applied to the overlap region of the first film-62% benzyl alcohol, 31% denatured ethyl alcohol, 5% potassium acetate, 2% DI water.

[Description of process]
Film 1 is thermoformed into single or multiple tablet / caplet shaped pockets in the platen, each pocket including a lower piston that can be raised and lowered as needed to fit standard size tablets and caplets. The tablet-shaped pocket further has an end cross-section raised around the upper perimeter of the pocket. This end section is raised 1 mm above the platen surface and in this embodiment has an upper flat portion with a land width of a predetermined dimension of 0.35 mm or similar order. The vertical sidewalls of these pockets are typically 3 mm deep.

  The thermoforming operation involves a film that functions as a film that divides the vacuum chamber into two, and these films are controlled separately. The bath above the film contains a flat heated platen at a temperature of about 140-145 ° C. A vacuum is applied over the film and the vacuum is held against the heating plate for 1-5 seconds, preferably 1.2 seconds. When the vacuum level in the lower tank reaches at least 0.94 bar (-94 kPa), the vacuum in the upper tank is released into the atmosphere or replaced with positive pressure for 1.2 seconds. This applied differential pressure pushes the film down from the heated platen and places it on the lower tablet pocket shaped tool. In this way, the film takes the shape of a tablet pocket with the lower molding tool.

  In one embodiment, the thermoformer can further preheat the film (ie, before contacting for 1.2 seconds). In a preferred preheating step, the heated thermoformer plate is placed on the film without contacting the film for a predetermined period of time (eg, 3 seconds).

[Powder administration and film 1 cutting]
The powder dosing and consolidation assembly is then placed over the film forming pocket. The dozeter places a dose of powder into the slider mechanism of the dosing and compaction assembly, thereby transferring the powder into the film pocket. In a preferred embodiment, the compaction and cutting of the film takes place via a compacting piston that advances to a fixed stopper after the film is cut.

  The level of compaction is controlled by the mass of powder deposited in the dosing sleeve and the depth of the formed film cavity. As the consolidation piston advances, the film is perforated and cut because it interferes with the inner edge of the raised end section. Consolidation and drilling are performed when moving continuously to the fixed stopper position once.

  The fit tolerance between the cutting piston and the inner dimension of the raised edge cross-section is such that the diameter clearance is 35 microns or less.

  The device is generally made of stainless steel and the piston top is made of hardened steel. The equipment is machined and supplied by Midland Tool and Design, Birmingham, UK.

[Second film pasting, cutting and ironing]
The partially enrobed core is then lifted upwards within the molding tool so that half of the formed tablet sidewall is higher than the raised end cross section. An adhesive is applied around the side wall of the tablet and / or the first formed film that adheres to the second film to be thermoformed. A typical adhesive level on the order of 20 gsm is applied to the surface via a number of suitable devices. In a preferred embodiment, the adhesive is applied to the first film on the sidewall, rather than the second film. Typically, 15 gsm is the minimum amount of adhesive that can be applied.

  The film is then thermoformed in the same manner as described for the first film, except that the film is removed by a barrier (spacer) plate 188 so that film positioning does not damage the top surface of the tablet. Hold above the tablet. For the second thermoforming, it is possible to use low temperatures (e.g. 50-170 ° C, preferably 140-165 ° C). In a preferred embodiment, the thermoformer plate contact heats the film for 1.5 seconds and thermoforms for 1.5 seconds. This overworking limits the thermal exposure of the powder surface. The second cut is performed by a combined transfer and cutting device tool designed such that the cutting device portion forms a piercing cut on the outer edge of the raised end section of the lower forming tool. The cut diameter fit tolerance is, for example, 25 microns for the diamond-shaped dosage form width, the acceptable range is 17-36 microns, and the diamond-shaped dosage form length is, for example, 31 microns; The acceptable range is 20-42. The scrap film web is then removed and the fully enrobed powder core is pushed through a compacted tablet-shaped ironing unit (heated orifice), for example at 40-60 ° C., and an overlap seal Is formed.

[Example 2]
The same conditions as in Example 1, except that the following steps replace the “powder dosing and film 1 cutting” stage.

[Powder administration and film 1 cutting]
The dosing assembly is then placed over the film forming pocket. It consists of a position mask placed on the alignment in the platen and a dosing sleeve that rests directly above the film-forming pocket and rests on the raised end section. The dosing sleeve exactly matches the dimensions of the film-forming pocket. A dose of powder is deposited in the dosing sleeve and falls into the film pocket. Cutting occurs through a cutting piston that acts through the dosing sleeve and sweeps the remaining powder into the lower film pocket. The level of compaction is controlled by the mass of powder deposited in the dosing sleeve. The cutting piston cuts through the film while interfering with the inside of the raised end section. The cutting piston continues to engage the edges that are raised by an additional 0.2 mm, and in doing so, further compacts the powder into the film shell. The fit tolerance between the cutting piston and the inner dimension of the raised edge cross-section is such that the diameter clearance is 25 microns or less.

  The device is generally made of stainless steel and the piston top is made of hardened steel. The equipment is machined and supplied by Midland Tool and Design, Birmingham.

  Thus, the tablet is pushed down into the sealed area of the pocket by the cutting piston and rests on the lower piston. The position mask and dosing sleeve and scrap film web are then removed.

[Example 3]
Same as Example 1, except that the fitting tolerance of the first cutting piston is the same as that of the second cutting piston.

[Example 4]
Same as Example 2, except that the fitting tolerance of the first cutting piston is the same as that of the second cutting piston.

Details of the features and processes of an exemplary device used to accurately dispense and compact powder into a fully enrobed collection of powder slag are described. The device used in the above process consists of the following assembly.
A. A platen assembly including a cavity in which a powder slag or tablet is formed.
B. Thermoforming unit.
C. Powder dosing and consolidation assembly.
D. Inkjet assembly.
E. Transfer arm and cutting device assembly.
F. Ironing unit.
G. Platen cleaning unit.

[Outline of preferred rotating device]
As described in more detail below, the various processes are performed on a turntable 300 (as shown in the plan view of FIG. 4A) that supports the platen 22 and the first and second films 480, 482.

  The turntable is rotatable to move each of the plurality of platens between the four operating stations [1-4]. Films 480, 482 are fed from known types of rolls and indexed on the surface of the turntable in the direction of arrow 485 after each enrobe process. Thus, in the embodiment shown in FIG. 4A, a new film is fed from upstream (the lower part of the page), and a scraped film web that is full of holes is downstream (towards the top of the page). Move to.

  The turntable includes a plurality of film lifters 490 (see also FIG. 4B). In this example, there are four film lifters, one is upstream of each station performing the film forming and cutting process sna and the other is downstream. A film lifter is a bar that is placed under the film in the same plane as the platen surface and extends substantially across the width of the film in a direction transverse to the direction of flow. The lifter is movable with respect to the platen surface so that it is below (or flush with) the platen surface so that the film rests on the platen surface or higher than the platen surface and the film is peeled off the platen surface. To be able to. To move the lifter with respect to the platen, (i) lift the associated lifter using the lifter drive mechanism 497 or (ii) lower the platen. In this way, it is possible to remove the scrap film web from the platen surface and lift the rest cleanly from the film so that the turntable rotates and the film is indexed forward. In the removing step, it is preferable that the relative movement of the lifter and the platen can be emphasized by the movement of the lifter and the platen in the opposite direction.

  Station [1] is an in situ consolidation station where the powder slag is consolidated in the film pocket in the first of the two enrobe processes. To do this at station [1], the thermoformer 100 can be automatically moved to a position on the first film 480 and the platen 22 and of the powder dosing and compaction unit 130a / b. The same is true in both cases.

  The fresh portion of film 480 is pre-conditioned by a thermoformer and “formed” in each pocket (cavity) in the platen with the help of pressure and / or vacuum. The film pocket is then filled by an in situ consolidation process that produces a partially enrobed powder slag / tablet using a compacted piston as previously described. The partially enrobed powder slag is cut from the film web by the continuous movement of the compacting piston before the lifter strips the scrap film from the platen and the turntable rotates and moves the platen to station [2]. The

  Station [2] comprises a high precision jet spray assembly 140 (based on well known ink jet technology) for applying adhesive to the partially enrobed powder slug. In this exemplary process, the adhesive is applied to the sidewalls, so that the powder slag is raised with respect to the platen using the lower piston 24 and the piston drive mechanism described in detail below. When the adhesive is applied, the turntable rotates and the platen moves to station [3].

  Station [3] performs a second enrobe process in which the second film is “formed” directly onto the partially enrobed powder slag provided with adhesive. Station [3] includes a thermoformer 100, a transfer and cutting device arm 460, and a barrier plate 495 (also referred to herein as a “spacer plate”). As will be described in detail, the barrier plate is disposed between a film that is controlled by the thermoforming phase and a partially enrobed powder slag. Since the film needs to be formed directly on the powder slag, the barrier plate is provided with an opening through which the film can be formed with the help of pressure and / or vacuum. In use, the barrier plate 495 locks the film 482 in place against the heated surface of the thermoformer 100 to protect the partially enrobed powder slag from heat and / or physical damage. After the film is formed on the partially enrobed powder slag, the scrap film web is separated from the fully enrobed powder slag by operation of the combined transfer and cutting device tool 460. This arm performs the second film cutting operation already described in detail and also uses this arm to transfer the fully enrobed powder slug to the adjacent ironing tool 470. Thus, the transfer and cutting device arm 460 is a single device operable to perform the cutting and transfer operations in stage [3]. As will be described in detail below, the arm cutting device is provided outward facing the bore with the cutting edge and inward facing the surface with the transfer gasket. In use, the cutting device continues to move towards the fully enrobed powder slag, fully accommodating the slag in its bore, and to some extent this ensures that the slag is on the transfer gasket from the cutting device side. It is press-fitted into. The transfer and cutting device arm 460 then swings to a position below the ironing tool 470 where an upwardly movable pusher finger provided on the movable support is a transfer gasket (opposite the cutting device). Is used to extrude and squeeze the powdered slug through the ironing tool 470. The finger stops moving upward for a period of time, irons the seam of the enrobed slag and then continues to move upward to push the finished powder slag / tablet onto the ironing tool. to recover.

  Finally, the platen is rotated to station [4] where it is cleaned by the cleaning unit 400 prior to a new process cycle. Preferably, the various steps of this process are performed simultaneously on different platens. That is, four process cycles are executed simultaneously. In this case, the lifter is used regularly in the sense that the two stations [1], [3] perform the film forming process during all rotations.

[Description of platen]
Illustrations of the complete platen and piston assembly 20 are shown in FIGS. 5A-5B and FIGS. 6A-6B.

  Each platen 22 is made of a stainless plate and has a row of cavities 48 on the surface. The cavity has a vertical wall and has the same cross-sectional shape as the tablet to be formed, see Figures 8A-B and 9A-B. There is a raised edge 44 around each cavity 48 having the portion shown in FIGS. 8B and 9B. This feature is for the process of cutting the film formed on the tablet in the second part of the process. Note also that the concave surface 42 protects the raised edges and supports the film higher than the edges prior to the first thermoforming operation.

  The bottom of each cavity is formed by the surface 32 of the piston 24. Each piston fits within the respective cavity (maximum diameter clearance 25 microns) and enters the bottom of the cavity by a compression spring 29 held firmly down and fitted around a narrow portion of the piston. The force of the spring presses the end of this narrow section against the surface of the cam that is used to control the vertical position of the piston and thus the depth of the cavity.

  Details of the piston shape are shown in FIGS. 7A-7F. Note the indentation on the front face 32 of the piston 24 and the square edge 34 around the recessed surface shown in FIG. 7F.

  Both the piston and platen have small holes 36, 46 (about 0.5 mm in diameter) in them to create a vacuum in and around the tablet cavity in two thermoforming processes that form part of the process. used. The platen vacuum hole 46 is shown in FIG. 8B, and the piston vacuum hole 36 is shown in FIGS. 7A, 7B, 7C, 7D, and 7F.

  The lower pistons of the platen are preferably stationary at the first station, but they are, for example, at station [2] for bonding and at station [3] for the second enrobe process. Used to energize powder slag.

[Description of powder dosing and compaction unit]
The described embodiment comprises a rotatable powder dosing and compaction assembly 420, which comprises two powder dosing and compaction units 130a, 130b. Therefore, during use, one unit 130 is being filled and the other is being dispensed and consolidated.

  The dozeter mechanism supplies powder from a bulk powder source to the respective powder dosing and compaction units 130a, 130b. The powder dosing and compaction unit has the following three functions.

  a. The powder dose is received from the dozeter and transferred to the consolidation cavity.

  b. Compress the powder into the cavity.

  c. The film formed in the cavity is cut and thereby separated from the “crumb” film.

  With reference to FIGS. 10 and 11, each powder dosing and compaction unit 130 includes a slider mechanism 50. The slider mechanism 50 is two mated as shown in FIGS. 10 and 11 to form a cavity 54 that is substantially the same size as the lightly preconsolidated slug dispensed from the dozer head. It consists of forming plates 52 and 53. The assembly of these two plates 52, 53 has a position "A" where the cavity is filled with powder (or preconsolidated powder slag) and the powder is at the lower limit by the piston 24 of the platen 22, and at the other end. It is possible to slide with respect to each other between positions “B” drawn on the consolidation chamber, delimited at the upper limit by the piston 82 of the consolidation unit. This is explained in more detail below with reference to FIG.

  In order to ensure that the plate cavity 54 is completely filled with powder, it is preferably lightly pre-consolidated from a known type of dozer head 124, as shown in FIG. 19C. Filled with slag.

  In situ (“in-film”) compression of the powder uses a single row of pistons 82 attached to the “dosing piston holder” 70 above position “B”, as shown in FIGS. Done. 15A-C illustrate a compression piston 82, noting the indentation 92 on the front of the piston and the square edge 94 around the face shown in FIG. 15C. Therefore, as will be described below, the piston can pass through the bore formed at position B by the plates 52 and 53 to consolidate the powder and cut the film.

[Description of thermoforming unit]
Details of the thermoforming unit, including a view of the holes in the heating plate, are shown in FIGS.

  The thermoforming unit 100 consists of a flat heating plate 109 mounted in a bath that leaves only the exposed surface of the heating plate. The thermoforming unit further includes a heater cover 103, a heater 105, an upper block, and a heating plate 109. The vessel is connected to a vacuum source, and the vacuum is connected to the surface of the heating plate by a number of aligned small holes 108 (diameter about 0.5 mm). These holes are characteristic of two thermoforming processes that are part of the process. These prevent air bubbles from being trapped between the film and the plate.

  In fact, thermoforming is most effective if there is sufficient contact between the preconditioned film and the thermoformer plate 109. In a preferred embodiment, the thermoforming process brings the powder dosing and compaction unit 130 onto the thermoformer at station [1] and is fixed on the film, and at station [3], additional top fixing. Assisting by providing the assembly.

[Description of thermoforming process]
This process begins with thermoforming a film on the platen 22.

  A piece of film is placed on the platen 22 and the thermoforming unit 100 is positioned thereon. The thermoforming unit is then pressed onto the film and platen. This completes a divided vacuum chamber, and the film acts as a membrane that separates the upper tank (thermoforming unit) and the lower tank (platen). Contact between the underside of the film and the top surface of the platen can be improved by applying additional pressure on the thermoformer, as appropriate. At station [1], this can be done by the mechanical dosing of the powder dosing and compaction unit, and at station [2] by providing a separate suitable upper securing assembly.

  The thermoforming process begins by connecting a vacuum to the upper bath. This draws the film onto a controlled temperature heating plate, which is typically 180 ° C. Estimated values for heating plate temperature, film heating time, and lower bath vacuum level are standard values, but not deterministic values. The optimum values for these parameters depend on the physical properties of the film used and thus on film formation. In general, different films require different operating parameters. After an adjustable period of a few seconds, a further vacuum is connected to the lower vessel and the cavities in the platen are evacuated. Then, after the vacuum level in the lower tank reaches a set level (typically -0.6 barg (60 kPa) to -0.8 barg (-80 kPa)) and the film heating time has elapsed, Ventilation inside is performed. As a result, the film is formed in the cavity of the platen by the differential pressure applied to the film. The thermoforming unit is then lifted away from the platen to complete the thermoforming process.

[Description of powder administration process]
After the film is thermoformed, the powder dosing and consolidation units 130, 50, 70 are placed on the platen 22.

  The cavities 54 in the plates 52, 53 are slid to a position A accessible to the dozer head 124 and paused for a predetermined time so that they can be filled. Lightly preconsolidated slag is dispensed from the dozer head 124 and multiple dozer cycles may be required to fill all of the cavities 54. The plate is then slid to position “B” and the cavity 54 (currently filled with powder) is directly above the cavity 48 in the platen. By operation of the piston 82, all of the powder in the plate cavity 54 is swept out and consolidated into the film to form a plurality of partially enrobed powder slugs.

[Description of powder compaction process]
A compacting piston 82 is pushed through the plates 52, 53 to push the powder into the platen cavity lined with film (ie, into the film pocket). Further force is applied to compact the powder and form a hard tablet within the film shell formed in the platen cavity. In the preferred embodiment, the lower piston 24 of the platen 22 is stationary during the process performed at station [1].

  The size of the finished tablet is fixed by the depth of the film forming pocket and is independent of the amount of powder transferred because the stroke length of the compaction piston 82 is fixed. If the force applied to consolidate the powder exceeds that required to perform the entire stroke, a range of tablet weights can be achieved within the fixed size of the finished tablet. In the next step, the partially enrobed slag is cut from the scrap film web (first film).

[Description of film cutting process]
With the final movement of the compacting piston to cut the first film, the piston enters the top of the platen cavity. The piston 82 enters approximately 0.1 to 0.4 mm below the upper flat portion of the raised end section 44 of the platen cavity 48. Preferably, the piston 82 enters about 0.1 to 0.4 mm below the upper flat portion of the raised end section 44. This perforation cuts the film, thus cutting the partially enrobed slag from the sheet of film on which the slag was formed. Thus, in a preferred embodiment, the film is sheared between the piston flat and the inner edge of the cavity.

  The movement of the compacting piston into the platen cavity is a beneficial feature of the preferred cutting process. This creates a tablet with a very distinct edge and overall shape compared to alternative methods using alternative compression and cutting processes.

  The cutting of the second film (formed on the top of the tablet later in the process) is done in a similar manner, but in this case the cutting tool is a hollow provided in the transfer and cutting arm. It is a tableting tool. In that case, the cutting tool engages the outer edge of the raised cross section of the platen cavity and shears. This transfer arm and cutting tool are described in detail below with reference to FIGS. 18C and E.

[Direct heat formation on powder slag / tablet]
The second film forming step is performed directly on the partially enrobed powder slag. The partially enrobed powder slag is raised from the surface of the platen so that it can be easily enrobed. Preferably, the powder slag is raised around just over half the depth of the sidewall so that at least half of the remaining uncoated can be enrobed. In fact, the choice of the amount that the slag must be raised depends on a number of factors, including the geometry and process in the first enrobe step and the desired degree of overlap.

  A spacer plate 188 (see FIG. 18A) is prepared at a predetermined distance, for example, 5 mm above the platen surface. The spacer plate 188 is in the same plane as the platen surface and is fixed relative to the platen throughout the second enrobe process. The spacer plate is a platen surface that borders a partially enrobed powder slug with an opening 1805 having a sufficiently large cross-sectional area to expose a plurality of enrobed powder slugs held in the underlying platen With a small area. This opening is preferably provided with a sealing member around it to assist sealing in the thermoforming process. The spacer plate further has a bore 1810 for fixing means such as a bolt and a bore 1808 for positioning lugs.

  Referring to FIG. 18B (i), the spacer plate 188 is fixed and raised above the platen surface before the second film is thermoformed onto the partially enrobed powder slag. Holds a partially enrobed powder slag 1815. Film 482 is provided on the spacer plate (different from the platen itself). The thermoformer 100 is disposed on the film and secures the film to the spacer plate-platen assembly. Although not shown here, the fixation effect is enhanced by using another fixation assembly on the thermoformer 100 (referred to herein as the “upper fixation assembly”). A process corresponding to that already described with respect to the previous thermoforming process is used to condition and form the film using vacuum and / or pressure.

  FIG. 18B (ii) shows that once formed, the second film 482 is forced through the opening 1805 and pressed against the raised, partially enrobed powder slag. The film is formed through the opening over the entire cross-sectional area of the opening such that a plurality of partially enrobed powder slugs are enrobed in a single step. When the thermoformer leaves, the fully enrobed powder slag is exposed in the web of scrap film and the cutting device on the transfer arm is brought into the opening and further fully enrobed powder slag. Can be in contact with cutting.

  Thus, the spacer plate has multiple purposes and beneficial effects. For example, this has the function of keeping the thermoforming unit away from the powder slag, and without it, it will be exposed to heat that can be denatured. This is the thermal barrier function of the spacer plate. The spacer plate further protects the powder slag from the swing of the thermoformer and transfer arm. This is the physical barrier function of the spacer plate. In use, the powder slag can only access the transfer arm if the positioning lug and the tapered thrust bore allow accurate placement.

  The second film covers approximately half of the tablet sidewall when half of the tablet is exposed on the platen and is cut at the outer edge of the raised end cross section. In a preferred embodiment, the only excess film available for overlap is the film that rests on the upper horizontal flat portion of the raised section before cutting. Therefore, if the width of the flat portion of the raised end cross section is 0.35 mm, the degree of overlap is the upper side of the raised end cross section to the amount of the enrobed sidewall exposed on the platen. Equal to the value obtained by adding the width of the flat portion on the surface. This depends on the exact tolerances and appropriate relevance between the film and the surface on which the film is formed. Thus, one of ordinary skill in the art can control how much the degree of overlap is in the second film process, how the amount of side walls already enrobed in advance depends on the position of the lower piston in the first step. You will understand what you can control.

[Transfer arm and cutting tool ("c-arm")]
FIG. 18C is an exploded view of the transfer and cutting arm. The transfer and cutting arm includes a movable support 1850, a positioning lug 1855, a cutting tool 186, a transfer gasket 1860, a back plate 1859, and securing means 1859.

  With particular reference to FIG. 18D, the cutting tool 186 has a cutting surface 1830 with a plurality of tablet-shaped holes 1825. Each hole has a cutting edge 1840 on the cutting surface 1830 and extends from the cutting surface to the non-cutting surface 1835.

  Adjacent to the uncut surface 1835 of the cutting tool 186 is a transfer gasket 180 (see FIG. 18C). The transfer gasket has a plurality of other tablet-shaped holes 182. These holes are slightly smaller than the holes in the cutting tool and after at least a portion is forced into the hole (after being pressed), the tablet / consolidated powder slug fits into the hole in the transfer gasket. Fit. The transfer gasket is PTFE (polytetrafluoroethylene) or PETP (polyethylene terephthalate), or less preferred, but a little flexible, such as silicon, but is elastic, making this press fit function optimal To do. PTFE tends to have the best elasticity, smoothness, and hardness for this gasket function. Thus, the likelihood of leaving a wound on the enrobed dosage form is low. This material is also food / pharmaceutical grade (eg FDA approved) as the gasket contacts the tablet.

  The gasket function is illustrated in detail in FIGS. The gasket is lined with a plurality of apertures 182 for receiving the compacted powder slag or tablets. As shown in FIG. 25B, the aperture is chamfered or tapered (ie, the diameter of the aperture 184 into which the tablet enters is, for example, 7.6 mm in diameter, but other apertures 183 have other diameters). The “upper” side is 6.9 mm in diameter). This construction of the gasket further irons the tablet as it enters through the wide aperture, pauses for transport, and exits the narrow aperture. Preferably, the recently enrobed and thus overlapping half of the tablet enters and exits the gasket.

  The transfer and cutting arms are shown in assembled form in FIG. 18E. It can be seen that the surface of the cutting device is exposed below the support material.

  In use, the arms are arranged to cut the fully enrobed powder slag from the scrap film web and transfer it to the ironing tool. The cutting action has already been described as shearing at the outer edge of the raised end cross section of the cavity 48. After the cutting operation, the arm proceeds further and the enrobed slug is housed in the cutting device and fed into the transfer gasket and press fit therewith. The enrobed slag can be removed from the press-fit engagement with the transfer gasket, for example by a finger pusher. Tablets with 4 mm side walls 187a and tablets with 3 mm side walls 187b are shown as tablet gasket 180 in FIG. 25C. FIG. 25D shows how the transfer arm is lowered and the second cutting device tool 186 cuts the tablet from the second film web, and FIG. 25E shows that the lower piston puts the tablet into the tablet gasket in the transfer arm. Shows where to push.

[Powder Dozer]
In a preferred embodiment, the powder dozer assembly is configured as shown in FIGS. 19A-C and 20A-C. FIG. 19A shows a dozeter 120 having a dozeter powder bowl 122 and a dozer feed head 124. The dozeter bowl is shown in detail in FIG. 19B, where there is an anti-clogging device 126 and a powder leveling device 125 or a doctor. The dozeter powder bowl rotates at a constant clockwise speed, and the powder is fed by a hopper to the dozeter dosing head as shown in detail in FIG. 19C. The dozeter dosing head comprises a dosing tube 128 and a rotating head 127 that rotates the dozeter dosing head. The dosing tube can be configured with an internal tamping pin (not shown) to preconsolidate the powder within the dosing tube and to transfer the powder from the tube to the pocket. In use, the dozer powder bowl rotates at a constant speed clockwise and the dozer powder bowl is fed with powder through a hopper system. The powder is set to a specific height by the dozer leveling device and the dozer head rotates on the dosing bowl. The dozeter tube is filled by lowering the tube to a known depth and placing it in a dozeter powder bowl. Internal tamping pins lightly pre-compact the powder, avoid spilling in the process and make it easier to process later. The powder is held in the tube due to the pre-consolidation effect, but the vacuum holding function can be used if necessary, that is, for very fine filled powders. (The fill volume can be changed by changing the depth at which the tube is lowered into the dozeter powder bowl.) The dozer head is then raised and rotated about 180 degrees, as shown in FIGS. At a location on the dosing unit 130 which will be described in greater detail in. The dozer head is lowered to the top of the dosing unit cavity 54 and the lightly pre-compacted slag is transferred from the dozeter tube to the other cavities of the dosing unit using an internal tamping pin. In this embodiment, the platen comprises 12 cavities with an 11 1/2 millimeter pitch. In this embodiment, the dozeter-head is equipped with six tubes, so the dosing unit is filled with two cycles of the dozer head. After releasing the dosing unit, the dozer head is raised and rotated on the dosing powder bowl in preparation for the next cycle.

  A powder compacted dosing assembly 130 is shown in FIGS. 20A-C and this implementation includes two dosing units 130a, 130b mounted on a rotor head assembly 131, as shown in FIG. 20A. Configured in form. The rotor head is driven by a servo motor. FIG. 20B shows the dosing unit in detail. Each dosing unit comprises a dosing sledge 50 having a dosing cavity 54 for holding the powder after release from the dosing tube of the dozer doser head. The dosing unit further houses a compacted piston 82, respectively. The pneumatic cylinder 50 can slide the sledge from the filling position to the dosing position and vice versa, as described above. Final placement in the dosing position can be achieved with a high precision locating pin actuated by a pneumatic cylinder.

  FIG. 20C shows a dozeter dosing head filling the dosing unit 130a at the dosing position and a dosing unit 130b ready to be dispensed into the film pocket in the cavity 48 of the platen 22. FIG. The dozeter powder tube 128 fills the slider cavity with powder. The rotor head 131 rotates the dosing units 130a and 130b. The dosing unit 130a takes the dosing position and dispenses into a pocket with a vacuum formed film. The compaction piston is then engaged, the powder is compressed in-situ and the film is cut as described above. While this occurs, the other dosing unit 130b is filled with a dozeter and is ready for the next machine cycle. At any given time, one dosing unit is in the powder filling position while the other dosing unit is in the processing position.

[Spray jet assembly]
In a preferred embodiment, the adhesive (paste) is applied prior to applying the second film over the partially enrobed slag, ie the first film and the powder slag. 21D-F show a spray jet assembly 140 using inkjet technology that can be used to spray adhesive in a pattern that is on a partially enrobed slug (or spray ink for printing). Show.

  The exemplary spray jet device 140 includes a sprayer 142 having three heads 147 that are supplied with an adhesive or other fluid. The position of the spray head 147 can be accurately controlled by the control electronics 144-148. The spray heads are controlled in a fixed configuration with respect to each other and sweep a row of partially enrobed powder slugs 145 raised on the platen 22 in the direction of arrow 149. In this manner, a predetermined amount of adhesive can be applied to the entire perimeter of each side wall of the partially enrobed slag in a single sweep. The screen 143 (shown in FIG. 21B) can be lifted to expose the partially enrobed slug and protect the platen 22.

  The spray process moves the lower piston 24 upward through the partially enrobed powder slug so that about half of the depth of each side wall is above the platen surface, then station [2]. Is executed.

[Cleaning unit]
The cleaning unit 400 includes a vacuum nozzle unit 150, which is applied to the platen as shown in FIG. 22 and prevents waste powder in the platen cavity. Air is forced through the nozzle and into the platen cavity when the vacuum nozzle unit is directed near the cavity and the platen hood 152 forms a seal with the platen so that the cleaning process can be performed.

[Turntable and platen support mechanism]
Referring to FIGS. 23 and 24, a turntable assembly 300 for holding a platen and transferring the platen from one station to the next during processing is described. The turntable indexing drive system 162 rotates the platen up to 90 degrees for each process cycle. The platen can be held on the turntable by the lower platen holding assembly 164 with a sealing retaining ring that can be secured to the turntable. The platen is raised from the turntable by the cam unit 170 shown in FIG. 24, where the rod 172 lifts the platen away from the turntable and the follower 174 is below the lower piston 24 in the platen 22. The pneumatic cylinder 178 raises and lowers the lower piston, and the pneumatic cylinder 176 raises and lowers the platen. The cam unit 170 is preferably an eccentric cam unit that uses, for example, a TOX unit (TOX is a trademark in some countries of the company Tox Pressotechnik GmbH & Co. KG, Germany).

  Preferably, the platen is lifted from the turntable so that the turntable is not exposed to compaction pressure during processing.

  By using this type of support assembly, each of the four platens can be processed simultaneously in four stations. For example, the first station [1] can perform dosing, compaction, and partial enrobe, and the second station [2] applies adhesive to the side wall of the partially enrobed slug. The third station [3] can perform a second film enrobe on the opposite side of the partially enrobed slug and perform ironing, The station [4] can be a platen vacuum cleaning station that uses air jets and vacuum to remove dust and suck to clean the platen.

[Detailed Examples of Preferred Rotation Process]
Station [1] dosing, compaction, and partial enrobe procedures are as follows. Index the film. The filled dosing unit 130a is rotated 180 degrees and placed in the processing position, and the turntable 160 is indexed up to 90 degrees and placed in the processing position. The platen 22 is lifted off the turntable and the lower piston 24 is set to the proper operating height using an eccentric cam. The film lifter assembly is lowered. The thermoformer 100 rotates 90 degrees and comes to the processing position. The powder dosing and compaction assembly including the dosing unit secures the thermoforming unit, film, and platen together, and the film is thermoformed into the platen cavity. The powder dosing and compaction assembly is disengaged and lifted using an air spring pneumatic cylinder. The thermoformer returns to the home position and the powder dosing and compaction assembly returns to secure the dosing unit to the platen. Precise placement is achieved using a tapered lug on the dosing unit and a spring-loaded tapered bush on the platen assembly. The dosing unit slider 132 is moved to the dosing position and fills the cavity 134. The compacting piston compresses the powder into the cavity to form a partially enrobed slag (or tablet) and then cuts the film in one motion. The powder dosing and consolidation assembly is released. The powder dosing and compaction unit is lifted using, for example, an air spring pneumatic cylinder. The film lifter is lifted and the scrap film is peeled off from the platen. The platen drops and returns to the turntable to enhance the peeling effect. The lower piston returns to the home position when the station 1 cam unit is lowered, and prepares for indexing the turntable. While this process occurred, the other dosing and compaction unit 130b was filled with a dozer head and is ready for the next machine cycle. Each powder dosing and filling of the compaction unit is performed in two passes because the platen cavities are arranged at closely spaced intervals (dosing takes place in six alternative cavities and then the rest).

  At station [2], the spray jet 140 applies adhesive to the side walls of the partially enrobed slag. This process begins with the turntable indexing up to 90 degrees and coming to processing position [2]. The platen 22 is lifted and removed by the station 2 cam unit and by the pneumatic cylinder 136, and the exact placement uses a tapered lug position on the underside of the inkjet body and a spring-loaded tapered bush on the platen assembly. Done. The lower piston 24 is set to the proper operating position using an eccentric cam so that the tablet is moved up from the cavity and placed at the correct level for adhesive application. The high speed outward stroke of the printhead assembly 140 is at the starting position. In a slow, constant speed inward stroke, the desired adhesive pattern (logo) is applied to the tablet using a printhead configuration. The platen falls back into the turntable and the lower piston returns to the home position when the station 2 cam unit is lowered. Prepare for turntable indexing.

  The turntable 300 is indexed up to 90 degrees to reach the processing position [3], and the transfer arm is rotated up to 90 degrees to a position below the ironing tool. The platen is lifted by the station 3 cam unit and removed from the turntable, and the lower piston is set to an operating height suitable for enrobing the partially enrobed slug using an eccentric cam. The thermoformer unit 100 film and lifter are lowered to apply a second film to the spacer plate over the partially enrobed slug. The transfer arm assembly is lifted and mated with the ironing unit using an air spring pneumatic cylinder and film index. The thermoformer rotates up to 90 degrees and is placed in the processing position, and the finger pusher assembly pushes the tablet into the ironing tool. The upper securing assembly secures the thermoformer, film, and platen spacer plate together. The transfer arm assembly is clearly lowered with the ironing unit using an air spring pneumatic cylinder and rotated 90 degrees back to the home position. The film is formed on the partially enrobed tablet and the ironing unit index advances to the next position. The upper fixation assembly disengages and the heat former returns to the home position. The finger pusher assembly ejects the completed tablets from the ironing tool, emptying the cavity row and preparing for the next tablet batch to be ironed. The picking head performs picking and placement operations and removes the product from the machine. The transfer arm is indexed 90 degrees and advanced to a cutting position on the platen. The upper assembly secures the transfer arm and its positioning lug mates with the spring-loaded tapered bushing of the lower platen assembly. Finally, a cut is performed at the true end of the upper fixation assembly stroke. The upper fixation assembly holds the transfer arm, spacer plate 188 assembly, and platen together. The spacer plate 188 includes a gap between the thermoformer and the partially enrobed slag so that the second film is formed prior to thermoforming the second film on the partially enrobed slag. During holding and heating, ie conditioning, the thermoformer will not damage the consolidated slag. The lower piston is reset to maximum height using an eccentric cam and draws or pushes / swells the tablet from the lower platen into the PEPT gasket contained in the transfer arm.

  The upper fixation assembly holds the transfer arm in a lowered state while the cut tablet is in the tablet gasket 180 that is received from the platen 20 into the arm using the lower piston of the lower platen assembly 20. It is transferred to. The upper securing assembly then disengages, the film lifter strips the litter film from the spacer plate 188 and the platen, and the transfer arm lifts the cutting device to clean the film and film lifter, with air spring air pressure Use a cylinder. The platen falls back into the turntable and increases the stripping effect, and the lower piston returns to the home position when the station 3 cam unit is lowered. The transfer arm is indexed 90 degrees under the ironing tool and advanced to the home position, and the finger pusher pushes the enrobed slug up from the transfer arm into the ironing tool.

  Station [4] has a platen vacuum 150 cleaning station that removes and aspirates dust using an air jet and vacuum, respectively. The turntable 160 is indexed up to 90 degrees and comes to the starting processing position. Next, the platen 22 is lifted by the station 4 cam unit 170 by a pneumatic cylinder and removed from the turntable. Initially, the lower piston 24 remains in the home position and the vacuum head 152 is lowered to engage the platen. The vacuum process begins and the lower piston is set to the upper operating height using a pneumatic cylinder until the vacuum process is complete. The platen falls back into the turntable and the lower piston returns to the home position when the station 4 cam unit is lowered and the vacuum head is lifted.

[Example process timing diagram]
A draft timing diagram 110 for the complete process is shown in FIG. 18 for clarity of the sequence of events for the thermoforming, dosing, consolidation, and cutting processes. It will be appreciated that processes and apparatus as described above provide several advantages. While specific embodiments of the invention have been described by way of example, it will be appreciated that various modifications may be made without departing from the scope of the invention as defined by the appended claims. Will.

FIG. 3 shows a basic consolidation and enrobe apparatus and process according to one embodiment of the present invention at step a-1. FIG. 2 shows a variation of the method shown in FIG. 1 using steps a1 and b1 according to an embodiment of the invention. FIG. 2 shows a variation of the method shown in FIG. 1 using steps a2-d2 according to an embodiment of the invention. FIG. 2 shows a variation of the method shown in FIG. 1 using steps a3-g3 according to one embodiment of the invention. 1 is a schematic diagram of a turntable device embodying the present invention. FIG. 4B is a diagram of a film lifter assembly of the type used in the embodiment of FIG. 4A. 1 is a top view (film side) of a platen assembly according to one embodiment of the present invention. FIG. 1 is a bottom view of a platen assembly according to an embodiment of the present invention. FIG. 5B is a cross-sectional view of the platen assembly of FIG. 5A taken along the arrow shown in FIG. 5A according to one embodiment of the invention. It is a figure which shows the cross section shown in more detail by the broken-line circle | round | yen of FIG. 6A. It is a perspective view of the lower piston by one Embodiment of this invention. It is a perspective view of the lower piston by one Embodiment of this invention. It is a front view which shows the front of the lower piston by one Embodiment of this invention. 7B is a cross-sectional view of the lower piston according to one embodiment of the present invention taken along YY and XX as shown in FIG. 7C. FIG. 7B is a cross-sectional view of the lower piston according to one embodiment of the present invention taken along YY and XX as shown in FIG. 7C. FIG. FIG. 7B is a cross-sectional view, shown in dashed circles in FIG. 7B, in a more detailed concave shape in front of the piston and square edges. FIG. 6 is a perspective view of a lower platen according to an embodiment of the present invention. FIG. 8B is a cross-sectional view shown by the dashed circle in FIG. 8A of a more detailed view of the recessed surface around the cavity and the raised edges around the cavity and the vacuum holes around the cavity. FIG. 8B is a cross-sectional view of the lower platen of FIG. 8A according to one embodiment of the present invention. FIG. 9B shows a cross-section indicated by the dashed circle in FIG. 9A with raised edges around the cavity. FIG. 6 is a perspective view of a slider mechanism of a dosing unit according to an embodiment of the present invention. FIG. 6 is a perspective view of a slider mechanism of a dosing unit according to an embodiment of the present invention. FIG. 12 is a front perspective view of the dosing unit of FIG. 11 engaged with a portion of a dozeter according to an embodiment of the present invention. FIG. 12 is a rear perspective view of the dosing unit of FIG. 11 engaged with a portion of a dozeter according to an embodiment of the present invention. 1 is a perspective view of a consolidation piston according to an embodiment of the present invention. FIG. 1 is a perspective view of a consolidation piston according to an embodiment of the present invention. FIG. FIG. 15B is a cross-sectional view indicated by the dashed circle in FIG. 15A. FIG. 3 is a cross-sectional view of a dozeter, a dosing unit, and a consolidation unit. 1 is a perspective view of a thermoformer according to an embodiment of the present invention. FIG. FIG. 17B is a perspective view of the underside of the assembled unit of the thermoformer of FIG. 17A. FIG. 6 illustrates an exemplary spacer plate according to an embodiment of the present invention. 1 is a schematic diagram illustrating how a film is formed through an opening in a spacer plate. 1 is a schematic diagram illustrating how a film is formed through an opening in a spacer plate. 1 is an exploded perspective view of a combined transfer and cutting tool according to one aspect of the present invention. FIG. It is a perspective view of the cutting apparatus of a combined transfer and cutting tool. FIG. 3 is a view of an assembled form of the combined transfer and cutting tool. 1 is a perspective view of a dozer table according to an embodiment of the present invention. FIG. 19B is a more detailed view of the dozeter powder bowl shown in FIG. 19A. FIG. 19B is a more detailed view of the dozer head shown in FIG. 19A. FIG. 6 is a perspective view of a dosing unit and rotor head assembly according to an embodiment of the present invention. FIG. 20B is a more detailed view of the dosing unit shown in FIG. 20A. FIG. 20C is a view of the dozeter dosing head shown in FIG. 19C filling the dosing unit shown in FIG. 20B. 1 is a perspective view of an inkjet assembly according to an embodiment of the present invention. 1 is a perspective view of an inkjet assembly according to an embodiment of the present invention. 1 is a perspective view of an inkjet assembly according to an embodiment of the present invention. 1 is a perspective view of a spray jet device according to an embodiment of the present invention from below with a platen in a spray position. FIG. It is another perspective view from the bottom when there is no platen. 1 is a schematic illustration of a spray jet operating. FIG. 6 is a perspective view illustrating a vacuum function for cleaning a platen and a pocket according to an embodiment of the present invention. FIG. 3 is a perspective view showing a turntable holding a platen for transferring the platen from one processing station to the other processing station according to an embodiment of the present invention. It is a perspective view which shows the cam unit for raising / lowering the platen regarding the turntable by one Embodiment of this invention. 1 is a view of a tablet gasket according to an embodiment of the present invention. It is sectional drawing taken along AA of the gasket of FIG. 25A. FIG. 6 is a cross-sectional view of a gasket positioned in a transfer arm with a tablet. FIG. 3 is a cross-sectional view of a platen assembly and a gasket. FIG. 3 is a cross-sectional view of a platen assembly and a gasket. FIG. 4 is an exemplary timing diagram of a system according to an embodiment of the invention. FIG. 4 is an exemplary timing diagram of a system according to an embodiment of the invention. FIG. 4 is an exemplary timing diagram of a system according to an embodiment of the invention. FIG. 4 is an exemplary timing diagram of a system according to an embodiment of the invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 1st film 2 Platen 3 Lower piston 4 Cylinder 5 Vacuum port 6 Powder 7 Powder slug 8 Second film 9 Upper piston 10 Cutting tool 12 Cutting tool 13 Iron 14 Second vacuum forming pocket 15 Vacuum forming pocket 16 Consolidated powder 17 Consolidated powder 20 Platen and piston assembly 22 Platen 24 Piston 29 Compression spring 32 Surface 34 Edge 36 Small hole 44 Raised edge 46 Small hole 48 Cavity 50 Slider mechanism 50 Dosing sledge 52 Molding Plate 53 Molding plate 54 Cavity 70 Dosing piston holder 82 Piston 92 Recess 94 Edge 100 Thermoformer 103 Heater cover 105 Heater 108 Small hole 109 Heating plate 120 Dozeter 122 Dozeter powder bowl 124 Dozer head 125 Powder leveling device 126 Anti-clogging device 127 Rotating rotating head 128 Dosing tube 130a Powder dosing unit 130b Consolidation unit 131 Rotor head assembly 132 Dosing unit slider 134 Cavity 136 Pneumatic cylinder 140 High Precision Jet Spray Assembly 142 Sprayer 143 Screen 144 Control Electronics 145 Powder Slag 146 Control Electronics 147 Head 148 Control Electronics 150 Vacuum Nozzle Unit 152 Platen Hood 160 Turntable 162 Indexing Drive System 164 Lower Platen Holding Assembly 170 Cam Unit 172 Rod 174 Followers 176 Pneumatic Sirin 178 Pneumatic cylinder 180 Tablet gasket 182 Aperture 183 Aperture 184 Aperture 186 Cutting tool 187a 4mm side wall 187b 3mm side wall 188 Barrier (spacer) plate 300 Turntable 400 Cleaning unit 420 Rotatable powder dosing and compaction assembly 460 Transfer and cutting device arm 470 Ironing tools 480, 482 First and second films 490 Film lifter 495 Barrier plate 497 Lifter drive mechanism 1805 Opening 1808 Bore 1810 Bore 1815 Raised partially enrobed powder slug 1825 Tablet shaped hole 1830 Cutting plane 1835 Non-cut surface 1840 Cutting edge 1850 Movable support 1855 Positioning lug 1859 Back Plate 1859 fixed means 1860 transfer gasket

Claims (36)

An apparatus for forming a film on a dosage form,
A platen for directly holding a plurality of oral dosage forms from which a film is formed;
At least one film supply arrangement;
At least one film adjustment unit;
A device comprising a barrier disposed between the film conditioning unit and the dosage form so that, in use, the barrier protects the plurality of oral dosage forms from the effects of film conditioning.   The apparatus of claim 1, wherein the barrier is disposed at a predetermined distance fixed from the platen.   Characterized in that the powder is compacted in a film formed in a pocket and comprises a compacting device capable of performing a film enrobing process to form one or more partially enrobed dosage forms. The device according to claim 1.   4. The barrier of any one of claims 1 to 3, wherein the barrier comprises an opening, the opening having a dimension sufficient to form a film on the plurality of dosage forms through the opening. The device according to item.   The apparatus according to claim 1, wherein the barrier includes a metal plate.   The apparatus according to claim 1, wherein the barrier includes a steel plate.   7. A device according to any one of the preceding claims, wherein the barrier comprises one or more positioning means.   8. Apparatus according to any one of the preceding claims, further comprising a securing assembly operable to secure the film adjusting means and the barrier.   9. A device according to any preceding claim, wherein the film conditioning means is a thermoformer that can be placed over the barrier on the opposite side of the dosage form on which the film is formed. . A method of forming a film directly on a dosage form comprising:
Providing a platen for directly holding the dosage form from which the film is formed;
Providing a film from a film supply arrangement on the barrier, the barrier being disposed between the film conditioning unit and the oral dosage form from which the film is formed;
Adjusting the film;
Forming the film directly on the oral dosage form. An apparatus for forming a film-coated dosage form comprising:
A platen comprising a platen surface comprising a plurality of locations for containing dosage forms;
A film conditioning unit that can be arranged to condition the film to impart properties to the film that allow the film to be formed on the dosage form at the location;
An apparatus comprising a barrier disposed between the platen surface and the film conditioning unit and comprising an opening through which the film can be formed when adjusted. A method of forming a film-coated dosage form comprising:
Providing multiple locations for storing dosage forms;
Providing a film formed on the dosage form;
A barrier disposed between the film and the dosage form, the barrier comprising an opening through which the film is formed directly on the dosage form;
Adjusting the film to impart properties that allow it to be formed;
Forming the film over the dosage form through the opening. An apparatus for forming a film-coated dosage form comprising:
One or more platens that are movable between a plurality of stations each performing a portion of an enrobing process that holds a dosage form;
A station where a conditioned film is formed on a target associated with the platen;
An apparatus comprising one or more film lifters operable to separate a scrap film from the platen after the forming step.   14. The apparatus of claim 13, wherein the platen is provided on a turntable that is rotatable between different stations of the plurality of stations.   15. The station of claim 13 or 14, wherein the station comprises a compaction device capable of compacting powder into a film formed in the pocket, and wherein the target comprises a recess for receiving the film pocket. The device according to any one of the above.   14. The station comprises an enrobe device that can enrobe the dosage form by forming a film directly on the dosage form, the target comprising one or more dosage forms. 15. The apparatus according to any one of 14.   A first film supply arrangement for supplying a first film to the compaction device and a second film supply for supplying a second film to the enrobe device when dependent on claim 15 17. The apparatus of claim 16, comprising an array.   18. A device according to any one of claims 13 to 17, comprising a spray jet station.   The apparatus according to claim 17, further comprising a cleaning station.   20. An apparatus according to any one of claims 13 to 19, comprising a film lifter upstream and downstream of the platen in the direction of film supply.   The said or each film lifter is a substantially horizontal bar whose length is arranged across the film feeding direction. 21. apparatus. A method of forming a film-coated dosage form comprising:
Providing at least one platen for holding a dosage form;
Supplying at least one film;
Adjusting the film to form on the target associated with the platen and providing at least partially enrobed product and waste film;
Separating the waste film from the platen after the forming step using one or more film lifters operable to push the waste film away from the platen;
Moving the platen. An apparatus for forming a compacted dosage form coated with a film comprising:
A compaction device capable of performing a first enrobe step in which a powder is compacted in a film formed in a plurality of pockets to provide a plurality of partially enrobed dosage forms;
An enrobe device capable of performing a second enrobe step in which the partially enrobed dosage form is enrobed to produce a fully enrobed dosage form;
A device comprising a combined transfer and cutting tool comprising a cutting device and a transfer gasket.   24. The apparatus of claim 23, wherein the cutting device comprises a cutting surface and a non-cutting surface, the cutting surface comprising a plurality of tablet-shaped cutting holes each extending from the cutting surface to the non-cutting surface. .   The apparatus according to claim 23, wherein the gasket includes a plurality of press-fitting holes.   24. The gasket according to claim 23, wherein the gasket is arranged so as to be close to the non-cut surface of the cutting device so that the cutting hole of the cutting device is linked to the press-fitting hole of the gasket. 26. The apparatus according to any one of 25.   Each of the plurality of press-fitting holes is tapered in cross section, the opening having the larger taper is directed toward the cutting device, and the narrow opening having the taper is used to hold the dosage form in a press-fitting manner. 27. Apparatus according to any one of claims 25 or 26, characterized in that it is suitable.   28. Apparatus according to any one of claims 23 to 27, wherein the gasket comprises a flexible elastic material suitable for containing tablets in a press-fit manner.   29. Apparatus according to any one of claims 1 to 28, wherein the gasket material is selected from one or more of PTFE, PETP, and silicon. A method of forming a compacted dosage form coated with a film, comprising:
Performing a first enrobe step in which the powder is consolidated into a film formed in a plurality of pockets to provide a plurality of partially enrobed dosage forms;
Performing a second enrobe step in which the partially enrobed dosage form is enrobed to produce a fully enrobed dosage form with a scrap film web;
A combined transfer and cutting device tool is used to cut the enrobed dosage form from the waste film web, and the cutting device cuts the fully enrobed dosage form from the web with the waste film web. Being engaged in cutting, further moving the cutting device over the dosage form, and press fitting the dosage form with a transfer component of the tool;
Transferring the fully enrobed dosage form. A combined transfer and cutting tool for cutting a dosage form from a scrap film web and holding the dosage form for transfer,
A cutting device comprising a plurality of cutting device holes extending between the cutting surface and the non-cutting surface;
A combined transfer and cutting tool comprising a transfer component provided near the uncut surface of the cutting device and having a plurality of press-fit holes linked to the holes in the cutting device. A method of cutting and transferring a dosage form from a film without using a combined transfer and cutting tool comprising a transfer component that follows a cutting device in the direction of cutting,
Positioning the combined transfer and cutting tool such that the cutting device holes of the cutting device can be cut into engagement with the scrap film web to cut the dosage form from the web;
Continuing to move the combined transfer and cutting device tool in the direction of cutting until the dosage form press fits into a press fit hole in the transfer component;
Transferring the dosage form. A method of ironing a plurality of enrobed dosage forms comprising:
Positioning a transfer arm and holding a plurality of enrobed dosage forms within a press-fit component of the transfer arm;
Positioning the transfer arm proximate to an ironing tool comprising a plurality of ironing orifices;
Activating a finger pusher to simultaneously push the plurality of dosage forms from the press-fit component to the ironing orifice in the ironing tool;
Considering a predetermined time so that the plurality of dosage forms are heated in the ironing orifice;
Activating the finger pusher to simultaneously push the plurality of ironed dosage forms from the ironing tool to a collocation position.   The dosage form comprises first and second enrobe layers, the dosage form being directed to direct a portion of the dosage form covered by the second enrobe layer and the ironing tool 35. The method of claim 32, wherein the method is provided to one or more of the following. An apparatus for forming a compacted dosage form coated with a film comprising:
A compaction device capable of performing a first enrobe step in which the powder is compacted into a film formed in a pocket to provide a partially enrobed dosage form;
An enrobe device capable of performing other enrobe steps in which the remainder of the partially enrobed dosage form is enrobed;
A jet sprayer operable to apply fluid to the dosage form. An apparatus for forming a compacted dosage form coated with a film comprising:
A powder reservoir;
A compaction device capable of compacting the powder in a film formed in the pocket to produce a partially enrobed dosage form;
Operable to deliver powder between the powder reservoir and the compaction device, recovering the powder from the powder reservoir, precompacting the powder, and then consolidating the compaction A powder dozer that is operable to be transferred to the chemical equipment,
Furthermore, the powder is consolidated by the compacting device,
The apparatus characterized in that the pre-consolidation by the powder dozer is carried out at a lower pressure than further consolidation by the compaction equipment.

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