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US3480468A - Process of preparing pharmaceutical tablet with orange-peel-like protective sugar coating - Google Patents

Process of preparing pharmaceutical tablet with orange-peel-like protective sugar coating Download PDF

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Publication number
US3480468A
US3480468A US526035A US3480468DA US3480468A US 3480468 A US3480468 A US 3480468A US 526035 A US526035 A US 526035A US 3480468D A US3480468D A US 3480468DA US 3480468 A US3480468 A US 3480468A
Authority
US
United States
Prior art keywords
coating
tablets
tablet
peel
orange
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
US526035A
Other languages
English (en)
Inventor
Luciano Carletti
Alessandro Rigamonti
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pfizer Italia SRL
Original Assignee
Farmaceutici Italia SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Farmaceutici Italia SpA filed Critical Farmaceutici Italia SpA
Application granted granted Critical
Publication of US3480468A publication Critical patent/US3480468A/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/005—Coating of tablets or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/20—Colour codes

Definitions

  • Farmoids constitute a new pharmaceutical form for oral administration in which a tablet containing the medicament is coated with a thin sugar film showing a wrinkled, orange-peel-like surface. This makes the f-armoid completely different from both tablets and coated-tablets. Contrasted to tablets, the farmoid shows an outer sugar coating, which besides being an outer protective coating, also facilitates the ingestion of unpleasant tasting substances. Contrasted to coated-tablets, the farmoid shows a less thick sugar-coating, the surface of which is wrinkled instead of smooth.
  • Tablet coating by paint which consists in using an appropriate resinous coating material with color optionally added. Upon completion of this operation, a coated form is obtained which completely diifers from the traditional coated tablet, in that the original tablet form is maintained.
  • Coating by dry compression which consists in welding around the tablet a mixture of suitably granulated powders.
  • a pharmaceutic form which differs completely from the traditional coated tablet, and consisting practically of two tablets one inside the other, is obtained.
  • the coating by paint method requires a shorter time for the coated tablet preparation than the traditional coating method. In spite of this costs are equally high, because the special resins and the large volumes of inflammable solvents required need expensive equipment, both for safety and recovery of resins and solvents.
  • the coating process by dry compression besides requiring particular and expensive equipment, is also subject to the remarkable limitation that the active ingredients do not exceed a fixed ratio with respect to the excipient.
  • Each new item also requires a preliminary and laborious setting-up of recipes for both the nucleus and the coating which not always are easy to weld.
  • Our invention has an object overcoming these difficulties and provides a method for coating an active substance tablet, using simple, low cost equipment while employing small quantities of the same raw materials used in traditional coating techniques.
  • Another object is to provide a distinctive coating.
  • the coating mixture in finely subdivided form in the warm and in the presence of air at a ratio of coating mixturezair between 1:4 to 1:20, the pharmaceutical form obtained has the outer appearance wrinkled and orangepeel-like instead of smooth with coated tablets.
  • Farmoids the new pharmaceutical form obtained according to the present invention, consist essentially of a tablet containing an average weight from 100 to 700' mg. of medicament around which from 30 to 200 mg. of excipients form the external coat.
  • the process comprises coating the tablets with a protective resinous material; heating the tablets at a temperature from 35 C. to 60 C. in a coating-pan rotating at 5 to 30 r.p.m.; and spraying, on the protected tablets, the solution or suspension for coating; said solution is maintained at a temperature of from 15" to C.
  • Farmoids have the advantages of coated tablets because of the protection from outside, sweet taste of the coat and agreeable outer aspect. Furthermore they show other advantages over coated tablets:
  • a coating pan Into a coating pan are put from 2 to 80 kg. of tablets (according to the capacity of the pan itself), to which a film of protective resinous substance has been first applied.
  • the coating pan is adjusted to a rotary speed, which depends upon the diameter of the pan itself and may be between 5 and 30 r.p.m.
  • heating is carried out by warm air, gas, vapor, infrared or other suitable heating sources. The heating is regulated so that the temperature of the tablets is between 35 and 60 C.
  • the pan is also provided with an appropriate aspiration system to remove the excess of spray over that required for the coating process.
  • Farmoids so obtained may be optionally polished with a polishing solution, such as natural or synthetic gums and resins like benzoin, lac gum or carnauba wax dispersed or dissolved in suitable solvents.
  • the equipment used for spraying the coating mixture comprises the following elements:
  • a paint spray gun having external or internal mixer nozzles provided with a spray head to produce a rather large spray pattern.
  • the pressure at which the liquid is sprayed is 0.5-2.5 atmospheres.
  • two or more spray-guns may be used;
  • a heating system which may be embodied into the cup or inserted between the cup and spray-gun. This system regulates the temperature of the coating mixture and of the air so that the required temperature is reached.
  • the spraying mixture consists essentially of a sugar solution having a density of between 1.15 and 1.37 at a temperature of 175 C.
  • Sorbital or saccharose may be employed as the sugar.
  • the sugar solution may be suitably charged with an inert excipient, such as calcium carbonate, titanium dioxide, starch, talc, natural gum, etc.
  • coloring substances which may be used in the practice of this invention, are any of the non-toxic dyes, which have been certified for use, in particular indigo carmine (ED. and C. Blue No. 2), sunset yellow (ED. and C. Yellow No. 6) erythrosine extra yellowish (RD. and C Red No. 3), tartrazine yellow (ED. and C. No. 5), amaranth red (RD.
  • the coating mixture may also be loaded with pharmaceutical substances which must be kept separated from the components of the tablet. Sometimes it is opportune also to add a plasticizing agent such as polyvinyl alcohol, polyethylene glycol or a surface-active agent such as a polyoxyethylene ester of sorbitol, etc. Small quantities of water-miscible solvents, preferably ethyl alcohol and acetone, may be added.
  • a plasticizing agent such as polyvinyl alcohol, polyethylene glycol or a surface-active agent such as a polyoxyethylene ester of sorbitol, etc.
  • Small quantities of water-miscible solvents preferably ethyl alcohol and acetone, may be added.
  • the coating liquid is sprayed onto the tablets by means of the spray-gun in the form of a mist, in which the ratio of liquidzair is between 1:4 and 1:20.
  • Example 1 25 kg. of tablets having an average weight of 500 mg. are placed into a copper pan with inside diameter of 84 cm. and provided with a suitable aspiration system. The tablets are conventionally prepared. The tablets are rounded, rather hard and surrounded by a protective film of natural gums or artificial resins. The pan is rotated at a speed of 9 rpm, and at the same time heated by gas to a tablet temperature of about 50 C. Onto the heated tablet the following solution is sprayed:
  • the coating solution is heated at about 80 C., the air at 20 C. and the equipment is adjusted to provide a pressure of 2 atm. in the general circuit, and 0.6 atm. in the cup containing the solution itself. Spraying is continued without interruption until the desired coat is obtained.
  • the average weight of the tablets, after such a treatment, is increased by about 30%.
  • the time required for the whole process is about 1 hour and 30 minutes.
  • the farmoids may be polished by one of the systems used for the polishing of coated tablets, e.g. applying lac gum and carnauba wax.
  • Example 2 Operating as described in Example 1, a paint having the following composition is employed:
  • Example 3 Opera ing as described in Example 1, a paint having the following composition is employed:
  • the temperature of the solution is kept at about 40 C., the temperature of the air at 50 C., and the equipment is adjusted to give a pressure of 1.5 atm. in the general circuit and 0.1 atm. in the cup containing the coating mixture. Nebulization is continued without interruption until the desired coat is obtained. The time required for the whole process is about 1 hour and 10 minutes, while the average Weight increases by about 25%.
  • the farmoids may be finally polished like coated tablets.
  • Example 5 Operating as described in Example 4, a paint with the following composition is employed:
  • Example 6 Operating as described in Example 4, a solution or suspension of a medicament having the following composition is sprayed on the tablet together with the coating paint:
  • a process for preparing a pharmaceutical form which comprises heating tablets from 35 to 60 C. in a coating pan rotating at from 5 to .30 r.p.m., spraying a protective sugar coating solution onto the tablets in the presence of air, the ratio of sugar mixture solution to air being between 1:4 and 1:20, under pressure, whereby the tablets are given an orange-peel-like protective sugar coating.

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
US526035A 1965-02-12 1966-02-09 Process of preparing pharmaceutical tablet with orange-peel-like protective sugar coating Expired - Lifetime US3480468A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT291765 1965-02-12

Publications (1)

Publication Number Publication Date
US3480468A true US3480468A (en) 1969-11-25

Family

ID=11103766

Family Applications (1)

Application Number Title Priority Date Filing Date
US526035A Expired - Lifetime US3480468A (en) 1965-02-12 1966-02-09 Process of preparing pharmaceutical tablet with orange-peel-like protective sugar coating

Country Status (8)

Country Link
US (1) US3480468A (xx)
AT (1) AT264716B (xx)
BE (1) BE676369A (xx)
BR (1) BR6677061D0 (xx)
DE (1) DE1617784A1 (xx)
ES (1) ES322957A1 (xx)
GB (1) GB1123336A (xx)
NL (1) NL6601426A (xx)

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3753767A (en) * 1971-08-02 1973-08-21 Colgate Palmolive Co Method of sugar-coating tablets
US3922339A (en) * 1974-06-20 1975-11-25 Kv Pharm Co Sustained release medicant
US4421738A (en) * 1979-07-31 1983-12-20 Eisai Co., Ltd. Sugar-coated tablet containing fat-soluble pharmaceutical material
US4423086A (en) * 1979-10-17 1983-12-27 Roquette Freres Process for hard coating with sorbitol and products obtained thereby
US5098893A (en) * 1989-02-16 1992-03-24 Pafra Limited Storage of materials
US5512314A (en) * 1993-02-24 1996-04-30 Warner-Jenkinson Company Dye compositions and methods for film coating tablets and the like
US6426210B1 (en) 1991-06-26 2002-07-30 Inhale Therapeutic Systems, Inc. Storage of materials
US6589560B2 (en) 1995-04-14 2003-07-08 Nektar Therapeutics Stable glassy state powder formulations
USRE38385E1 (en) * 1989-02-16 2004-01-13 Nektar Therapeutics Storage of materials
WO2006092423A1 (de) * 2005-03-04 2006-09-08 Nunner, Dieter Vorrichtung und verfahren zur beschichtung von kleinteilen
US7744925B2 (en) 1994-12-02 2010-06-29 Quadrant Drug Delivery Limited Solid dose delivery vehicle and methods of making same
US20110081415A1 (en) * 2005-03-10 2011-04-07 Taisho Pharmaceutical Co., Ltd Coating apparatus
US9598581B2 (en) 2013-03-15 2017-03-21 Mars, Incorporated Method of isolating blue anthocyanin fractions
US10750761B2 (en) 2015-06-30 2020-08-25 Mars, Incorporated Colorant compositions and methods of use thereof

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2467597A1 (fr) * 1979-10-17 1981-04-30 Roquette Freres Procede de drageification dure au sorbitol et produits ainsi obtenus
DE3221425A1 (de) * 1982-06-07 1983-12-08 Boehringer Ingelheim KG, 6507 Ingelheim Hydrolyseempfindlichen wirkstoff enthaltende, lagerstabile tablette
US5939091A (en) * 1997-05-20 1999-08-17 Warner Lambert Company Method for making fast-melt tablets

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3096248A (en) * 1959-04-06 1963-07-02 Rexall Drug & Chemical Company Method of making an encapsulated tablet
US3106492A (en) * 1961-09-01 1963-10-08 Upjohn Co Apparatus for coating discrete solids
US3331696A (en) * 1962-01-20 1967-07-18 Boehringer & Soehne Gmbh Dragee coating composition
US3361631A (en) * 1963-09-30 1968-01-02 Sandoz Ag Method of sugar coating pharmaceutical tablets
US3379554A (en) * 1964-04-21 1968-04-23 Merck & Co Inc Spray coating of pharmaceutical cores with a carboxylvinyl polymer and polyethylene glycol

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3096248A (en) * 1959-04-06 1963-07-02 Rexall Drug & Chemical Company Method of making an encapsulated tablet
US3106492A (en) * 1961-09-01 1963-10-08 Upjohn Co Apparatus for coating discrete solids
US3331696A (en) * 1962-01-20 1967-07-18 Boehringer & Soehne Gmbh Dragee coating composition
US3361631A (en) * 1963-09-30 1968-01-02 Sandoz Ag Method of sugar coating pharmaceutical tablets
US3379554A (en) * 1964-04-21 1968-04-23 Merck & Co Inc Spray coating of pharmaceutical cores with a carboxylvinyl polymer and polyethylene glycol

Cited By (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3753767A (en) * 1971-08-02 1973-08-21 Colgate Palmolive Co Method of sugar-coating tablets
US3922339A (en) * 1974-06-20 1975-11-25 Kv Pharm Co Sustained release medicant
US4421738A (en) * 1979-07-31 1983-12-20 Eisai Co., Ltd. Sugar-coated tablet containing fat-soluble pharmaceutical material
US4423086A (en) * 1979-10-17 1983-12-27 Roquette Freres Process for hard coating with sorbitol and products obtained thereby
US5098893A (en) * 1989-02-16 1992-03-24 Pafra Limited Storage of materials
USRE37872E1 (en) * 1989-02-16 2002-10-08 Inhale Therapeutics Systems, Inc. Storage of materials
USRE39497E1 (en) * 1989-02-16 2007-02-27 Nektar Therapeutics Storage of materials
USRE38385E1 (en) * 1989-02-16 2004-01-13 Nektar Therapeutics Storage of materials
US6825031B2 (en) 1991-06-26 2004-11-30 Nektar Therapeutics Storage of materials
US6426210B1 (en) 1991-06-26 2002-07-30 Inhale Therapeutic Systems, Inc. Storage of materials
US5512314A (en) * 1993-02-24 1996-04-30 Warner-Jenkinson Company Dye compositions and methods for film coating tablets and the like
US7744925B2 (en) 1994-12-02 2010-06-29 Quadrant Drug Delivery Limited Solid dose delivery vehicle and methods of making same
US7780991B2 (en) 1994-12-02 2010-08-24 Quadrant Drug Delivery Limited Solid dose delivery vehicle and methods of making same
US7785631B2 (en) 1994-12-02 2010-08-31 Quadrant Drug Delivery Limited Solid dose delivery vehicle and methods of making same
US6589560B2 (en) 1995-04-14 2003-07-08 Nektar Therapeutics Stable glassy state powder formulations
WO2006092423A1 (de) * 2005-03-04 2006-09-08 Nunner, Dieter Vorrichtung und verfahren zur beschichtung von kleinteilen
US20090017224A1 (en) * 2005-03-04 2009-01-15 Gerhard Brendel Device and method for coating small parts
US9950333B2 (en) 2005-03-04 2018-04-24 Special Coatings Gmbh & Co. Kg Device for coating parts including a movable receiver in which a dispenser device and an IR emitter device are located
US20110081415A1 (en) * 2005-03-10 2011-04-07 Taisho Pharmaceutical Co., Ltd Coating apparatus
US9598581B2 (en) 2013-03-15 2017-03-21 Mars, Incorporated Method of isolating blue anthocyanin fractions
US10119029B2 (en) 2013-03-15 2018-11-06 Mars, Incorporated Method of isolating blue anthocyanin fractions
US10750761B2 (en) 2015-06-30 2020-08-25 Mars, Incorporated Colorant compositions and methods of use thereof

Also Published As

Publication number Publication date
ES322957A1 (es) 1966-12-16
BR6677061D0 (pt) 1973-09-18
DE1617784A1 (de) 1971-12-30
GB1123336A (en) 1968-08-14
BE676369A (xx) 1966-06-16
AT264716B (de) 1968-09-10
NL6601426A (xx) 1966-08-15

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