WO2010063286A2 - A hand-held inhaler - Google Patents
A hand-held inhaler Download PDFInfo
- Publication number
- WO2010063286A2 WO2010063286A2 PCT/DK2009/000248 DK2009000248W WO2010063286A2 WO 2010063286 A2 WO2010063286 A2 WO 2010063286A2 DK 2009000248 W DK2009000248 W DK 2009000248W WO 2010063286 A2 WO2010063286 A2 WO 2010063286A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- hand
- pharmaceutical product
- inhaler according
- pressure
- medication
- Prior art date
Links
- 239000003814 drug Substances 0.000 claims abstract description 52
- 229940079593 drug Drugs 0.000 claims abstract description 42
- 239000002245 particle Substances 0.000 claims abstract description 15
- 238000000889 atomisation Methods 0.000 claims abstract description 9
- 230000002685 pulmonary effect Effects 0.000 claims abstract description 6
- 239000000839 emulsion Substances 0.000 claims abstract description 5
- 239000007788 liquid Substances 0.000 claims abstract description 5
- 239000000825 pharmaceutical preparation Substances 0.000 claims description 21
- 229940127557 pharmaceutical product Drugs 0.000 claims description 21
- 238000005086 pumping Methods 0.000 claims description 13
- 230000003068 static effect Effects 0.000 claims description 12
- 239000000243 solution Substances 0.000 claims description 4
- 230000008878 coupling Effects 0.000 claims description 3
- 238000010168 coupling process Methods 0.000 claims description 3
- 238000005859 coupling reaction Methods 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 239000004033 plastic Substances 0.000 claims description 2
- 229920003023 plastic Polymers 0.000 claims description 2
- 239000012080 ambient air Substances 0.000 claims 1
- 238000006073 displacement reaction Methods 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- 239000000843 powder Substances 0.000 abstract description 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 description 38
- 102000004877 Insulin Human genes 0.000 description 19
- 108090001061 Insulin Proteins 0.000 description 19
- 229940125396 insulin Drugs 0.000 description 19
- 238000002347 injection Methods 0.000 description 8
- 239000007924 injection Substances 0.000 description 8
- 238000007667 floating Methods 0.000 description 7
- 230000029058 respiratory gaseous exchange Effects 0.000 description 7
- 238000011161 development Methods 0.000 description 5
- 206010012601 diabetes mellitus Diseases 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000011521 glass Substances 0.000 description 4
- 210000004072 lung Anatomy 0.000 description 4
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 230000003434 inspiratory effect Effects 0.000 description 3
- 210000004879 pulmonary tissue Anatomy 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 206010020751 Hypersensitivity Diseases 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 208000026935 allergic disease Diseases 0.000 description 2
- 239000007864 aqueous solution Substances 0.000 description 2
- 230000000386 athletic effect Effects 0.000 description 2
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 229910052760 oxygen Inorganic materials 0.000 description 2
- 239000001301 oxygen Substances 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 206010063659 Aversion Diseases 0.000 description 1
- 241001269524 Dura Species 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 239000000443 aerosol Substances 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 229940127225 asthma medication Drugs 0.000 description 1
- 230000036770 blood supply Effects 0.000 description 1
- 230000035565 breathing frequency Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 210000002249 digestive system Anatomy 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 239000000428 dust Substances 0.000 description 1
- 230000005611 electricity Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000003380 propellant Substances 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 125000003003 spiro group Chemical group 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0065—Inhalators with dosage or measuring devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/07—General characteristics of the apparatus having air pumping means
- A61M2205/071—General characteristics of the apparatus having air pumping means hand operated
- A61M2205/073—Syringe, piston type
Definitions
- a hand-held inhaler for pulmonary administration in measured doses of liquid, sterile, low-viscosity emulsions and solutions thereof and powdered emulsions of drugs is used.
- the delivery frequency of the drug to the patient is adjustable or adapted to the individual user.
- the invention concerns varieties: A - B - C.
- the breathing is adapted for filtering off particles consisting of dust and droplets in the breathing air
- the described pressure reduction is brought about by mixing air being supplied to the atomization product from the surroundings.
- the area of the inlaid plunger is to be compared to the area of the pressure plunger against the medication mixture.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Nozzles (AREA)
Abstract
A hand-held inhaler for pulmonary administration of measured doses of liquid, sterile, low-viscosity emulsions and solutions thereof and powder emulsions of drugs. The use of a refill unit system (10), wherein the drug is delivered with an accurate calibration for nozzle atomisation, wherein a very high operational pressure occurs which takes into consideration both the desired degree of atomisation and a very small particle size without the use of other parameters such as e.g. increased temperature, etc. Likewise, the delivery frequency of the drug to the patient is adjustable or adapted to the individual user.
Description
A hand-held inhaler
A hand-held inhaler for pulmonary administration in measured doses of liquid, sterile, low-viscosity emulsions and solutions thereof and powdered emulsions of drugs. The use of a refill unit system wherein the drug is delivered with accurate calibration for nozzle atomization, wherein a very high operational pressure is provided which takes into account both the desired degree of atomization and a very low particle size without the use of other parameters such as eg elevated temperature, etc. Likewise, the delivery frequency of the drug to the patient is adjustable or adapted to the individual user. The invention concerns varieties: A - B - C.
Background
A number of drugs are conventionally delivered to the patient by injection directly into the bloodstream as it is not possible to perform oral ingestion, the active substance - one or more thereof - being soluble and decaying in the stomach and the digestive system.
Naturally, most patients who have to resort to the use of injections would like them to be eliminated in favour of inhalation, the physiological and mental factors being weighty.
Several physiological circumstances exist that have to be taken into consideration in the context of pulmonary uptake of drugs. 1. The uptake of the substance takes place in the alveoli of the pulmonary tissue
2. The breathing is adapted for filtering off particles consisting of dust and droplets in the breathing air
3. The pulmonary volume is varying, but limited 4. A high concentration of substance will entail a risk of allergy / irritation
5. Moreover the ratio of liquid to air should be below that which corresponds to 100 % of relative humidity.
Research has shown that particles below 5 μm maximizes the alveolar deposition, while simultaneously a certain kinetic energy must be imparted to those particles in order for them to reach all the way to the alveoli and a certain distribution to prevent cohesion between the particles.
It will appear from the above that the provision of a very small particle size is extremely important. Today, many manufacturers have attempted to produce equipment that takes those circumstances into consideration.
In particular in case of diabetes, the administration of insulin by inhalation may solve many problems in the light of the wide prevalence of the disease. According to the daily papers, diabetes has increased extremely heavily in the western world in recent years - mainly due to unhealthy lifestyles and too little exercise on the part of the individual. According to WHO, more than 2 % of the population have diabetes requiring medical treatment. Diabetes is an incurable disease and the sixth leading cause of death in the western world.
By inspiration, about (1/2 to 2.0) litres of air is inhaled, depending on the age and athletic exercise of the individual. In case of maximal breathing the maximal drawing in of air may constitute from 3.0 to 4.0 litres. The breathing air contains 21 % of oxygen. The absorption of oxygen as such takes place in the alveoli where the blood supply takes place through the capillaries of the pulmonary circuit. If one considers the breathing frequency at rest it is about 16 to 18 per minute. During vigorous athletic exercise it may increase to 60 per minute. It is natural for the practitioner of a patient to define the requisite amount of medication required in the clinical case in question. One could imagine that a dosage of from 2.5 to 5.14 ml of aqueous solution is deemed to be expedient per treatment step in case of inhalation. Likewise the intake
of medication is to be adapted to the general state of the patient to ensure that sufficient time elapses between each sequence as too high a concentration of substance in the pulmonary tissue may cause an allergy-like reaction.
US patent No. 20030005927 describes a pressurized dose inhaler wherein the medicament is dispersed in the propellant.
US patent No. 20020134382 and US patent 20020121277 describe the administration of dry powder medicament wherein it is the object of the invention to retain one or more medicament capsules. The inhalation takes place with and without compressed pressurizer and is released by the inhalation.
US patent No. 20020134382 describes an inhalation device which is layered and whose object it is to generate a turbulent medicament containment flow and secondarily an airflow for entraining the medicament.
Likewise, today hand-held aerosol inhalers are known. The structure primarily consists of a pressurized container containing multiple doses of drug. That type is used in the administration of asthma medication and insulin.
Likewise, many manufacturers have put a great effort into being able to offer patients insulin by inhalation seen in relation to the known method, whereby the patient is forced to perform an injection of insulin in his/her own bloodstream.
A focus market is concerned which has a very large growth potential. Likewise, it should be mentioned that research within this area is performed by relatively large companies whose market situation is that of an oligopoly.
Moreover, it should be mentioned that, conventionally, a pharmaceutical product has a long development sequence before the final marketing and therefore the present invention must be considered to be absolutely in the forefront.
lnhalable forms of insulin are subject to intensive development efforts with Pfizer, and Hoechst Marion Rousel has announced a cooperation concerning the issue of being able to produce inhalable insulin based primarily on technology from the company Inhale Therapeutic Systems. There, they have come a long way in terms of clinical tests, phase 3 being under development. Another group of companies consisting of Novo Nordisk and Aradigm has also come a long way in terms of an insulin product where it is weighted to enable delivery to the alveoli in the lungs of an patient of an insulin product where the particle size in the aqueous solution is below certain minimum limits that are fixed under the auspices of the company. Likewise, it should be mentioned herein that the daily papers have reported that the development concept of that group of companies has progressed so far that marketing in the year of 2008 is to be expected. Through many years Novo Nordisk has had patents worldwide on injection equipment known as the "Novopen" which is easy for all users to handle to the effect that the daily, accurate dose of insulin could be supplied to the body by injection. Another version of inhalable insulin is developed by EIi Lilly and Dura Pharmaceuticals. As administration system a battery-powered system is used therein in cooperation with T. Dura's Spiros.
Thus, those initiatives comprise that quite a lot of equipment uses evaporation of the pharmaceutical product to obtain the smallest possible particle size in order for uptake into the alveoli to take place.
To obtain a desired backpressure, an auxiliary unit in the form of a compressor is used in many cases.
All of the solutions described herein are associated with several drawbacks in view of the fact that, logically, heating of a pharmaceutical product must be considered to be inconvenient. Likewise, the use of a compressor unit to achieve backpressure is adverse even though the unit is battery-powered and even more if it is to be coupled to the mains supply.
Adverse parameters: Size, general handling of the equipment for the elderly.
It would be more attractive to the patient to use the equipment and to obviate injection.
It will appear from the above that the equipment available to day, based on user application, is not in any way discrete. As it is, there is no doubt that a patient does not desire to be the object of too much attention when he/she is forced, for the sake of staying alive, to deliver to his/her body the accurate amount of insulin to obtain the best possible quality of life.
Description of the invention
The present invention takes this into account as it is possible for the administration to be divided for a protracted period of time where one or more inhalations may occur and where it is possible to perform them at shorter or longer intervals, again in response to the general state of the user. Likewise, one may safely say that the patient is not given even the smallest possible part of a millilitre more than was intended as the dosage equipment is extremely accurate and incredibly easy to operate. Here, particular importance is attached to the situation where the established backpressure serves the overall purpose of providing a hitherto unknown degree of fineness of atomisation of the medication in aqueous form, whereas the
inspiratory air has only the excess pressure which is necessary for achieving the maximal degree of filing of the lungs.
The described pressure reduction is brought about by mixing air being supplied to the atomization product from the surroundings.
In brief:
Fine particulate pharmaceutical product + mixing air = inspiratory air static mixing 21 % of O2
+ (fine particulate portioned drug delivery)
The patient decides himself or herself: - sequence
- supplied amount per sequence (prescribed amount)
- consumption from supply (practitioner's participation)
Sequence between replacements of ampoule in dosage unit: From 1 week to one month.
Considered in total, there is a huge need for equipment that meets the described parameters.
The present invention relates to a sterile inhaler unit consisting of a handheld, manual air pump and an integral converter unit for providing backpressure onto the medication mixture and ensuring a degree of atomization that has not been known so far in an inhaler system, and an option of accurately measuring the doses for insulin or other pharmaceutical product. Likewise, the insulin product or any other pharmaceutical product is supplied to the inhaler unit as a refill unit system that ensures easy and user-
friendly insertion and replacement of the refill unit containing the desired pharmaceutical product.
The delivery of the pharmaceutical product will be controlled by the patient primarily through the breathing sequence of the patient, but, as a final result, the patient is caused to receive precisely the amount of medication prescribed for him/her. A prolonged inspiratory sequence will mean only that the patient receives pure air from the surroundings.
A typical course of inhalation will be inspiration of pure air in case of weak inspiration. In case of a slightly more forceful inhalation, the sub-pressure generated in the mouthpiece will cause the static mixer unit to move backwards and hereby open to a portion of the contents of drug which is supplied to the mixing air with a backpressure that ensures a very high degree of atomization. Likewise it is the patient who is capable himself or herself of taking a deep breathing sequence which ensures that the medicament-containing air is delivered to the total lung volume for maximal absorption and distribution in the lungs, concluding with a phase of breathing pure air.
The system is very simple and operates in accordance with the objective that the patient himself or herself is capable of adjusting all parameters to the effect that the medicament-containing air brings about the maximal effect. As mentioned, the supply of medicament-containing air may take place as one large inhalation or in several smaller ones or it may be adapted 100 % to the user.
The refill unit system:
The refill unit system may be configured in many ways, but a typical method is that the drug is supplied in a glass tube with rubber sealing at the front and a floating rubber plunger which can be displaced in the longitudinal direction
of the refill unit. The dosage system consists of a tube with a micrometer scale and a cap which is screwed onto the tube. The cap has an -o- line indication and internal pressure plunger. At the bottom of the tube, a disc with short cannula tube is inserted.
Insertion of refill unit:
The cap is unscrewed - the refill unit inserted - the cap is screwed back on. When the cap is turned the cannula pipe is pressed through the rubber sleeve of the glass tube and the micrometer setting of the cap indicates - 0 - . Further turning of the cap measures off precisely the desired dose down into the pressure chamber. The measured-off dose of medicament now awaits the backpressure sequence.
The backpressure sequence: By turning out of the locking function of the pumping part of the inhaler, a number of pumping movements are made until the indicator of the part sets forth that the building up of pressure is at eg 0.5 to 0.8 bar of superatmospheric pressure. That superatmospheric pressure is, at the release key of the pumping part, built up in both converter part and in the chamber of the pumping part, as a resting pressure against the large plunger area. Hereby a further air consumption is thus reduced. The built-in ball valves serve as intake valve towards the free environment and the pressure valve towards the pressure chamber, respectively. The pumping part is turned to the locking function and fixed therein. The inhaler is now ready for use.
Description of the converter part
When the small superatmospheric pressure is delivered to the converter part by depression of the release key of the pumping part, the following occurs:
The area of the inlaid plunger is to be compared to the area of the pressure plunger against the medication mixture.
The inlaid plunger: diameter 30 mm. The diameter of the medication plunger may be eg 6 mm.
It will appear from this that even a small pressure onto the large plunger area will be converted by a factor to achieve a state of equilibrium. The manufacturer is free to chose more or less all scales.
The medication chamber:
As described above, the desired amount of medication dosed is delivered accurately down into the medication chamber, whereby the converter plunger is allowed to move back due to the inlaid spring in the converter part. Also in this context there is no risk of oxidising the product even in case the equipment is laid aside for a protracted period of time. The medication chamber ends by a screwed-in nozzle for coupling with the needle valve of the static mixer. The nozzle / the needle valve are provided with very small areas which are to stay tight against the medication pressure.
Static mixer
The static mixer is arranged in the mouthpiece of the equipment. When the patient inhales - large or small inhalation - the needle valve may be set in advance to open, adapted to the desired sequence.
Pure air - medicated intervals - pure air
The mouthpiece is provided with a number of holes that ensure supply of clean air which may be admixed with atomised - fine particulate - pharmaceutical product.
The following parameters have been taken into consideration.
The system operates in accordance with the sequence desired by the patient, whereby the medicated air achieves maximal effect. The delivery of medicated air may take place as one large inhalation or as several smaller ones.
The pharmaceutical product will be atomized with a particle size which is very small as it takes place at a hitherto unprecedented superatmospheric pressure.
The pharmaceutical product does not undergo any detrimental influence before it is delivered to the patient.
The amount of drug is delivered in precisely the desired amount.
The user is capable himself or herself of adapting the sequence which fits best.
No use of other aids such as compressor, electricity, batteries, and pressure containers.
The assembly is made up of mechanical components having a long life expectancy. Likewise, the equipment may be made of plastics or metal.
The equipment has a user-friendly appearance and is suitable for travelling and it may be used discretely or on a private location.
One of the principal parameters of the system is that a refill unit system is used which enables use of equipment on long journeys, eg to remote destinations, while still providing the user with the requisite reliability against a life-threatening disease.
The patient will know when the refill unit amount of the drug has been spent and therefore he or she may adapt the sequence which is necessary by replacement of the refill unit.
The refill units will come in sterile packings provided with the manufacturer's logo, name and other relevant data.
Finally, it should be mentioned that the storage of new refill units is adapted to the manufacturer's own requirements - inserted refill unit in the equipment is very much protected against external influences such as impacts, influence of the sun, the influence of the O2 of the air, and others.
The mouthpiece is dismountable and may without much difficulty be provided with a sterile cover, should that be needed.
Finally, it should be mentioned that it is found to be important that the inhaler unit is made child-proof
General description of the invention
The invention is characterised in that it is a hand-held insulin inhaler consisting of inexpensive components.
The concept described herein must be considered to be of great importance as solutions to all very important parameters are pointed to, parameters that manufacturers of insulin have worked with for many years without really having reached a final result. Likewise it should be mentioned that the present concept is to be considered to be very relevant and produced at a point in time when large manufacturers have the same theme on the drawing board or immediately in the preliminary stages where the product for inhalation has been developed, but where the weak point is to provide
equipment that contains the same all-inclusive parameters have been described in the context of the present invention.
In conclusion, the invention consists of few parts that are suitable for large- scale production which, in assembled state, constitute a hand-held inhaler for inhalable, liquid drugs, operating with a refill unit system and manually built backpressure, and having a very accurate dosage system that ensures that the insulin product is delivered to the patient's pulmonary tissue with a defined particle size and a customized inhalation sequence.
The product is intended for users of insulin who, at present, have to perform injections of one or more daily doses, but where development has enabled that the manufacturers of insulin have it as their overall objective to be able to offer an insulin product for inhalation in order to thereby obviate the very widespread aversion against having to inject into one's own bloodstream several times a day/night. Likewise, there is a major risk associated with injections in third-world countries due to deficient hygiene standards.
List of drawings: In order to provide an overall picture of the invention, the following are produced:
Fig. A shows inhaler with converter for achieving large backpressure Fig. B shows inhaler without converter, operates with actual pumping pressure
Fig. C shows inhaler without converter, operates with externally supplied pressure.
All scales can be amended Scale: 1 :1 for figures A - B - C
Through-going important parameters: The refill unit system with micrometer setting, static mixer, medication pressure chamber, manually operated air pump and the conveyor system - fig. A.
Description of: Fig. A.
Converter housing (1)
Return spring (2)
Converter plunger (3) with o-ring seal Medication plunger (4) with o-ring seal
Movable air pump part (5)
Pumping volume for air (6)
Pumping plunger for air (7) with o-ring seal
Ball valve / relief function (8) Release key for pressure build-up in converter (9)
Refill unit: glass tube / floating plunger (10)
Micrometer screw with calibration (11)
Puncturing disc with cannula pipe (12) with o-ring seal
Locking function for (1) (5) - detail: K Standard valve function (14) (15)
Mouthpiece housing (16)
Nozzle (17)
Fresh-air supply (18)
Static mixer with needle valve (19) Medicated /pure air intake (20)
Measured amount of medication (21)
Relief valve for delivered drug (22)
Central bore for air to converter (23)
D ueessccrπipptτiioσnπ o ofτ:: f τiιgg.. B D
Base block with pressure chamber for pharmaceutical product (1)
Floating plunger with return spring (2)
Movable pumping part (5)
Pumping volume for air (6)
Pumping volume for air (7) with o-ring seal Ball valve / relief function (8)
Release key for medication pressure (9)
Refill unit: glass tube / floating plunger (10)
Micrometer screw (11)
Puncturing disc with cannula pipe o-ring seal (12) Locking function (1) (5) - detail: K
Standard valve function (14) (15)
Mouthpiece housing (16)
Nozzle (17)
Fresh-air supply (18) Static mixer with needle valve (19)
Medicated / pure air - intake (20)
Measured amount of drug (21)
Relief valve for delivered medication (22)
Central bore for air for floating medication plunger (23)
Description of: fig. C
Base block with pressure chamber for pharmaceutical product (1)
Floating plunger with return spring (2)
Container (5) Container volume (6)
Central part of container (7)
Ball valve / relief function (8)
Release key: ON / OFF (9)
Refill unit with floating plunger (10) Micrometer screw with o-setting (11 )
Puncturing disc with cannula tube, o-ring seal (12)
Relief valve for pressurised air (14)
Coupling for pressure build-up (15)
Mouthpiece (16)
Nozzle (17)
Fresh-air intake (18)
Static mixer (19)
Medicated / fresh air (20)
Amount of medication (21)
Relief valve for delivered amount of drug (22)
Claims
1. A hand-held inhaler for pulmonary administration of a pharmaceutical product, such as measured doses of liquid, sterile, low-viscosity emulsions, suspensions and solutions thereof, comprising a refill medication unit, a medication chamber, a nozzle, a static mixer, and a pressurized container, wherein said refill medication unit comprises a dosage device for micrometer dosing of the pharmaceutical product contained therein, and wherein said pharmaceutical product is, following dosing by means of said dosage unit, conveyed into said medication chamber, and wherein said pharmaceutical product can be released from said medication chamber through said nozzle by application of pressure from said pressurized container, whereby said pharmaceutical product is atomized and mixed with the ambient air through said static mixer, whereby the mixture can be inhaled by the user.
2. A hand-held inhaler according to claim 1 , wherein said pressurised container comprises means for coupling with an external pressure system, such as a container or a pump, with which the backpressure is built up.
3. A hand-held inhaler according to claim 1 , wherein said pressurized container comprises a manual pumping unit with which the backpressure is built up.
4. A hand-held inhaler according to claim 1 , wherein said pressurized container comprises a converter unit with which the backpressure is built up.
5. A hand-held inhaler according to claim 4, wherein the build-up backpressure which is built up by means of said converter unit can be increased by the factor 1 :40, whereby the desired degree of atomization is achieved.
6. A hand-held inhaler according to claims 1 - 5, comprising a needle valve and a stop spring, wherein said needle valve is used for stop against the built-up pressure impact, wherein the force of said stop spring is small whereby the inhalation by the user is the triggering factor for axial displacement of both needle valve and static mixer which are mechanically connected.
7. A hand-held inhaler according to claims 1 - 5, wherein said inhaler comprises a perforation element with cannula pipes that are pressed through the finishing rubber / plastics sleeve of the medication refill unit, whereby the access conditions for the pharmaceutical product are established.
8. A hand-held inhaler according to claims 1 - 5, comprising a integral indicator and a pressure control valve, wherein said indicator indicates the superatmospheric pressure build up in the inhaler, and wherein said pressure control valve ensures that a pressure ratio which is higher than a physiologically expedient pressure ratio is not built up.
9. A hand-held inhaler according to claims 1 - 8, wherein said pharmaceutical product is atomised through said nozzle with a particle configuration wherein the largest particle size is 5 μm or less.
10. A hand-held inhaler according to claims 1 - 8, wherein said pharmaceutical product is atomized through said nozzle with a particle configuration wherein the larges particle size is 5 - 15 μm.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200801714 | 2008-12-04 | ||
| DKPA200801714 | 2008-12-04 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2010063286A2 true WO2010063286A2 (en) | 2010-06-10 |
| WO2010063286A3 WO2010063286A3 (en) | 2010-07-22 |
Family
ID=42197694
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/DK2009/000248 WO2010063286A2 (en) | 2008-12-04 | 2009-12-03 | A hand-held inhaler |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2010063286A2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104049093A (en) * | 2014-06-17 | 2014-09-17 | 江苏大学 | Numerical-control dosing metering pump for detecting COD (chemical oxygen demand) and metering method |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020121277A1 (en) | 2001-03-01 | 2002-09-05 | Pera Ivo E. | Pen-shaped inhaling device for dispersing powdered medicaments through the respiratory tract |
| US20020134382A1 (en) | 2000-05-10 | 2002-09-26 | Snow John M. | Medicament container with same side airflow inlet and outlet and method of use |
| US20030005927A1 (en) | 1996-03-29 | 2003-01-09 | Van Oort Michiel Mary | Process and device for inhalation of particulate medicaments |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4227899A1 (en) * | 1993-09-24 | 1994-02-24 | Pfeiffer Erich Gmbh & Co Kg | Discharge mechanism for fluidic media with discharge head(s) - has distributor(s) with medium receiver(s) for distribution and stationary reception of at least one medium |
| DE10225470A1 (en) * | 2002-06-08 | 2003-12-18 | Boehringer Ingelheim Int | Mechanical memory aid for marking specified events comprises joinable base and setting elements which are movable relative to one another and are provided with their respective markings |
| AU2005262940B2 (en) * | 2004-04-02 | 2010-07-01 | Creare Incorporated | Aerosol delivery systems and methods |
| JP2008515606A (en) * | 2004-10-12 | 2008-05-15 | アラダイム コーポレーション | Apparatus and method for generating an aerosol from a liquid formulation and ensuring its sterility |
| WO2008049433A1 (en) * | 2006-10-27 | 2008-05-02 | Trendtech A/S | Hand-held drug inhaler for administration of pharmaceutical or technical products |
-
2009
- 2009-12-03 WO PCT/DK2009/000248 patent/WO2010063286A2/en active Application Filing
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030005927A1 (en) | 1996-03-29 | 2003-01-09 | Van Oort Michiel Mary | Process and device for inhalation of particulate medicaments |
| US20020134382A1 (en) | 2000-05-10 | 2002-09-26 | Snow John M. | Medicament container with same side airflow inlet and outlet and method of use |
| US20020121277A1 (en) | 2001-03-01 | 2002-09-05 | Pera Ivo E. | Pen-shaped inhaling device for dispersing powdered medicaments through the respiratory tract |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104049093A (en) * | 2014-06-17 | 2014-09-17 | 江苏大学 | Numerical-control dosing metering pump for detecting COD (chemical oxygen demand) and metering method |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2010063286A3 (en) | 2010-07-22 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US6125844A (en) | Portable oxygen based drug delivery system | |
| US20220126036A1 (en) | Systems and methods of aerosol delivery with airflow regulation | |
| EP0940154B1 (en) | Device for delivering aerosolized medicaments | |
| US9757528B2 (en) | Nebulizer having different negative pressure threshold settings | |
| AU2008203465B2 (en) | Device, system and method for targeting aerosolized particles to a specific area of the lungs | |
| AU2010266231B2 (en) | Nebulizer for infants and respiratory compromised patients | |
| ES2623577T3 (en) | Computer-readable methods, systems and products to optimize the administration of aerosol particles to the lungs | |
| JP2927836B2 (en) | Drug supply device | |
| EP3950028A1 (en) | Systems and methods of aerosol delivery with airflow regulation | |
| US20170368275A1 (en) | Nebulizer for infants and respiratory compromised patients | |
| HU225182B1 (en) | Systems and methods for aerosolizing pharmaceutical formulations | |
| JP2002504833A (en) | Device for administering insulin at a controlled dose by controlling the total inhalation volume | |
| KR20130099125A (en) | Inhaler | |
| US6539939B2 (en) | Multi-function oral breathing support system | |
| JPH06509958A (en) | powder dispenser | |
| NL1025556C1 (en) | Device and method for administering a fluid to a human or mammal. | |
| WO2010063286A2 (en) | A hand-held inhaler | |
| WO2008049433A1 (en) | Hand-held drug inhaler for administration of pharmaceutical or technical products | |
| US20230302233A1 (en) | Edta for treatment of cystic fibrosis and other pulmonary diseases and disorders | |
| AU2013209385B2 (en) | Nebulizer for infants and respiratory compromised patients | |
| Gardenhire et al. | Respiratory Therapists |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 09795685 Country of ref document: EP Kind code of ref document: A2 |
|
| 122 | Ep: pct application non-entry in european phase |
Ref document number: 09795685 Country of ref document: EP Kind code of ref document: A2 |