KR850001689A - Preparation of Aerosol Composition - Google Patents

Preparation of Aerosol Composition Download PDF

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KR850001689A
KR850001689A KR1019840004923A KR840004923A KR850001689A KR 850001689 A KR850001689 A KR 850001689A KR 1019840004923 A KR1019840004923 A KR 1019840004923A KR 840004923 A KR840004923 A KR 840004923A KR 850001689 A KR850001689 A KR 850001689A
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component
chamber
components
mixing chamber
mixture
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로드릭로스(외 2) 앨라스테어
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원본미기재
스터어링 드럭그 인코포레이팃드
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/127Liposomes
    • A61K9/1277Processes for preparing; Proliposomes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans

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  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
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  • Pulmonology (AREA)
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  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

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Description

에어로솔 조성물의 제법Preparation of Aerosol Composition

본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음As this is a public information case, the full text was not included.

Claims (45)

물로 구성된 제1성분과 지방물질로 구성된 제2성분, 적어도 2개의 분리된 성분을 가압하에 함께 혼합한 다음 혼합물을 가압하에 노즐 또는 기타 니른 장치를 통해 통과시켜 저방입자를 함유하는 에어로솔 스프레이를 생성하는 것으로 구성된 지방입자 제조방법.A first component consisting of water, a second component consisting of fatty material, and at least two separate components are mixed together under pressure and then the mixture is passed under pressure through a nozzle or other niche device to produce an aerosol spray containing low particle size. Fat particle manufacturing method consisting of. 제1항에 있어서, 상기 제1성분 또는 제2성분중 적어도 하나가 생물학적으로 활성이며, 거나 인간 또는 동물체 치료에 유용한 비지방 활성물질을 함유하는 방법.The method of claim 1, wherein at least one of the first component or the second component is biologically active or contains a nonfat active substance useful for treating a human or animal body. 제2항에 있어서, 상기 활성물질이 제1 또는 제2성분중에 용액으로 존재하는방법.The method of claim 2, wherein the active substance is present in solution in the first or second component. 제2항 또는 3항에 있어서, 활성성분이 생물학적으로 활성인 시약인 방법.The method of claim 2 or 3, wherein the active ingredient is a biologically active reagent. 제2항 내지 5항중 어느 하나에서 활성물질이 항원 또는 항체인 방법.The method according to any one of claims 2 to 5, wherein the active substance is an antigen or an antibody. 제 2항 또는 3항에 있어서, 상기 활성물질이 치료용으로 또는 화장품용으로 활성인 방법.4. A method according to claim 2 or 3, wherein said active substance is active for therapeutic or cosmetic use. 제6항에 있어서, 활성물질이 기관지확장제, 항천식화합물, 항종양제, 항염제, 피임약 또는 단백동화스테로이드인 방법.The method of claim 6, wherein the active substance is a bronchodilator, an asthma compound, an antitumor agent, an anti-inflammatory agent, a contraceptive pill or an anabolic steroid. 제6항에 있어서, 활성물질이 비톨테롤 및 그에스테르, 스태노졸롤, 하이드로코리손 및 그 에스테르, 스태노졸롤, 하이드로코티손 및 그 에스테르, 베타메타손 및 그 에스테르살부타믈, 레오필린, 나트륨 크로모글리케이트 아세틸-무라밀-알라닐-이소글루타민 또는 프로프라놀졸로부터 선택된 화합물인 방법.7. The active substance according to claim 6, wherein the active substance is bitolterol and its esters, stanozolol, hydrocortisone and its esters, stanozolol, hydrocortisone and its esters, betamethasone and its esters salbutaml, leophylline, sodium chromogly Kate acetyl-muramil-alanyl-isoglutamine or propranosol. 제2항 또는 3항에 있어서, 활성성분이 영양가를 가지고 있는 하나 또는 그 이상의 화합물인 방법.The method according to claim 2 or 3, wherein the active ingredient is one or more compounds having nutritional value. 제1항 내지 9항중 어느 하나에서 제2성분의 지방물질이 양성, 음성 또는 중성지방입자가 제공되도록 선택된 인지질 물질인 방법.10. The method of any one of claims 1 to 9, wherein the fatty substance of the second component is a phospholipid substance selected to provide positive, negative or triglyceride particles. 제10항에 있어서, 제2성분중 지방물질이 포스파티딜콜린, 포스파티딜에탄올아민 또는 포스파티딜세린 단독이거나 또는 하나 또는 그 이상의 지방물질과 콜레스테롤 및/또는 적어도 하나의 디세틸 포스페이트, 포스파티드산 또는 스테아릴아민으로 구성된 인지질인 방법.11. The method of claim 10, wherein the fatty substance in the second component is phosphatidylcholine, phosphatidylethanolamine or phosphatidylserine alone or one or more fatty substances and cholesterol and / or at least one dicetyl phosphate, phosphatidic acid or stearylamine. Method that is composed of phospholipids. 제11항에 있어서, 제2성분이 중성지방입자가 얻어지도록 선택되며, 포스파티딜콜린과 콜레스테롤이 8 : 1-2 몰비로 구성되어 있는 방법.12. The method of claim 11, wherein the second component is selected such that triglyceride particles are obtained and the phosphatidylcholine and cholesterol are comprised in an 8: 1 to 1 molar ratio. 제11항에 있어서, 제2성분이 음성 하전 지방입자가 언어지도록 선택되며 포스파티딜콜린, 콜레스테롤과 디세틸포스페이트가 8 : 1-2 : 1-0.5의 몰비로 구성되어 있는 인지질로 구성된 방법.12. The method of claim 11, wherein the second component is selected so that the negatively charged fat particles are lingual, and consists of phospholipids consisting of phosphatidylcholine, cholesterol and dicetylphosphate in a molar ratio of 8: 1: 1: 10.5. 제11항에 있어서, 제2성분이 음성하전 지방입자가 얻어지도록 선택되며 포스파티딜콜린, 콜레스테롤과 포스파티드산 이 약 8 : 1-2 : 1-0.1 몰비로 구성되어 있는 인지질로 구성된 방법.12. The method of claim 11, wherein the second component is selected to obtain a negatively charged fat particle and consists of phospholipids comprising about 8: 1: 1: 10.1 phosphatidylcholine, cholesterol and phosphatidic acid. 제11항에 있어서, 제2성분이 음성하전 지방입자가 제공되도록 선택되며 포스파티딜콜린, 콜레스테롤과 스테아릴아민이 8 : 1-2 : 1-0.5의 몰비로 구성된 인지질로 되어 있는 방법.12. The method of claim 11, wherein the second component is selected to provide negatively charged fat particles and wherein the phosphatidylcholine, cholesterol and stearylamine consist of a phospholipid consisting of a molar ratio of 8: 1: 1: 1-0.5. 제11항 내지 15항중 어느 하나에서 포스파티딜콜린이 디팔미토일 포스파티딜콜린이거나 또는 레시틴 형태인 방법.The method of any one of claims 11-15, wherein the phosphatidylcholine is dipalmitoyl phosphatidylcholine or in the lecithin form. 제1항 내지 제16항중 어느 하나에서 제1성분 pH가 생리적범위내로 유지되기에 적합한 양의 완충제 또는 완충시스템을 함유하고 있는 방법.The method of any one of claims 1-16, wherein the method contains an amount of buffer or buffer system suitable for maintaining the first component pH within the physiological range. 제1항 내지 17항중 어느 하나에서 제2성분이 생리적으로 허용되는 액체 부형제를 포함하는 방법.18. The method of any of claims 1 to 17, wherein the second component comprises a physiologically acceptable liquid excipient. 제18항에 있어서, 부형제가 지방물질과 상기한 어떤 활성성분이 모두 녹을 수 있는 휘발성 유기용매인 방법.19. The method of claim 18, wherein the excipient is a volatile organic solvent in which both the fatty substance and any of the above active ingredients are soluble. 제18항에 있어서, 액체 부형제가 에탄올, 클로로포름, 에테르 또는 이소프로필 알콜인 방법.The method of claim 18, wherein the liquid excipient is ethanol, chloroform, ether or isopropyl alcohol. 제1항 내지 20항중 어느 하나에서 제1성분이 생리적으로 허용되는 액체부형제외에 몰을 포함하는 방법.21. The method of any of claims 1-20, wherein the first component comprises mole in addition to the physiologically acceptable liquid excipient. 제21항에 있어서, 부형제가 휘발성, 수혼화성유유기용매인 방법.The method of claim 21 wherein the excipient is a volatile, water miscible organic solvent. 제22항에 있어서, 용매가 에탄올인 방법.The method of claim 22, wherein the solvent is ethanol. 제1항 내지 23항중 어느 하나에서 제1 및 제2성분을 적어도 하나의 에어로솔분사체에 의해 생성된 압력하에 혼합하는 방법.24. The method of any of claims 1 to 23, wherein the first and second components are mixed under pressure generated by at least one aerosol spray. 제24항에 있어서, 분사체가 하나 또는 두 성분 모두의 구성원인 방법.The method of claim 24, wherein the spray is a member of one or both components. 제25항에 있어서, 분사체가 제2성분의 구성원이며 압력이 분사체를 경유하여 그로부터 분리되어 있는 제1성분내로 적용되는 방법.27. The method of claim 25 wherein the injector is a member of a second component and pressure is applied into the first component separated from there via the injector. 제24항 내지 26항중 어느 하나에서 하나 또는 각각의 분사체가 할로겐화탄화수소나 할로겐화탄화수소의 혼합물인 방법.27. The method of any one of claims 24 to 26, wherein one or each of the sprays is a halogenated hydrocarbon or a mixture of halogenated hydrocarbons. 제24항 내지 27항중 어느 하나에서 하나의 또는 각각의 분사체가 디클로로디플루오로메탄인 방법.28. The method of any one of claims 24 to 27, wherein one or each of the sprays is dichlorodifluoromethane. 제24항 내지 27항중 어느 하나에서 하나의 또는 각각의 분사체가 약 25-30psi까지 압력을 내는 저압 분사체인 방법.28. The method of any one of claims 24 to 27, wherein one or each of the injectors is a low pressure injector that pressurizes to about 25-30 psi. 제29항에 있어서, 하나의 또는 각각의 분사체가 디클로로디플루오로메탄과 디클로로테트라디플루오로에탄의 20 : 80w/w 혼합물인 방법.30. The method of claim 29, wherein one or each of the sprays is a 20:80 w / w mixture of dichlorodifluoromethane and dichlorotetradifluoroethane. 제24항 내지 27항중 어느 하나에서 하나의 또는 각각의 분사체가 약 70psi까지 압력을 내는 고압분사체인 방법.28. The method of any one of claims 24 to 27, wherein one or each of the injectors is a high pressure jet pressurized to about 70 psi. 제31항에 있어서, 하나의 또는 각각의 분사체가 디클로로디플루오로메탄과 디클로로테트라디플루오로에탄의 80 : 20w/w 혼합물인 방법.32. The method of claim 31, wherein one or each of the sprays is an 80:20 w / w mixture of dichlorodifluoromethane and dichlorotetradifluoroethane. 제1항 내지 32항중 어느 하나에서 상기 제1 및 제2성분이 각기 서로 분리되어 공급되며 성분들 각각이 그들 자신의 분사체압력하에서 혼합실 내에 조절된 용량으로 공급되며 이렇게 형성된 혼합물을 혼합분사체압력하에 오리피스를 통해 혼합실로부터 배출되는 방법.33. The mixture spray of any of claims 1 to 32, wherein the first and second components are supplied separately from each other and each of the components is supplied at a controlled capacity in the mixing chamber under their own spray pressure. Discharge from the mixing chamber through an orifice under pressure. 제2항 내지 33항중 어느 하나에서 제1 및 제2성분이 상기 활성물질이 계량된 양 공급되는 방식으로 혼합되는 방법.34. The method of any one of claims 2 to 33, wherein the first and second components are mixed in such a way that the active substance is metered in. 제33항 또는 34항에 있어서 제1성분을 혼합실내로 공급하여 혼합실을 채운 다음 제2성분 계량된 양을 두 개의 성분이 난류혼합될 수 있는 방식으로 혼합실내 공급해준 다음 혼합물을 배출시키는 방법.35. A method according to claim 33 or 34, wherein the first component is fed into the mixing chamber to fill the mixing chamber and then the metered amount of the second component is fed into the mixing chamber in such a way that the two components can be turbulently mixed and then the mixture is discharged. . 팩이 적어도 제1실 및 제2실로 구성되며 그중 1실이 물로 구성된 제1성분을 함유하며 나머지 1실이 액체 물질로 구성된 제2성분을 함유하며 2실중 어느 하나나 또는 두 개 모두 또는 제3실이 분사체물질을 함유하며 책이 분사체물질(들)에 의해 전개된 압력하에 각실로부터 공급된 제1 및 제2성분의 혼합물을 스프레이로서 분배하는 장치를 포함하는 지방 입자에어로솔을 제조하는데 사용되는 팩.The pack consists of at least a first chamber and a second chamber, one chamber containing a first component consisting of water and the other chamber containing a second component consisting of a liquid substance, either or both or a third of the two chambers. Used to produce a fatty particle aerosol comprising a device containing a spray material and a device for dispensing, as a spray, a mixture of the first and second components supplied from each chamber under pressure developed by the spray material (s). Being pack. 제36항에 있어서, 상기 제1 또는 제2성분중 적어도 하나가 생물학적활성인 및/또는 인간 또는 동물치료에 유용한 비 지방 활성물질을 포함하는 팩.37. The pack of claim 36, wherein at least one of said first or second components comprises a non-fatally active substance that is biologically active and / or useful for human or animal treatment. 제37항에 있어서, 분배장치가 성분들의 혼합비를 조절된 범위내로조절할 수 있어 바라는 개량된 양의 상기한 활성물질을 분배할 수 있는 그런것인 팩.38. The pack of claim 37, wherein the dispensing device is capable of adjusting the mixing ratio of the ingredients within a controlled range so as to dispense the desired amount of the active substance described above. 제36항 내지 38항중 어느 하나에서 하나 또는 그 이상의 분사체에 의해 전개된 압력하에 각 실로부터 상기 제1 및 제2성분을 혼합실내로 분배되게 해주며, 성분들의 비를 계량된 범위내로 조절해주어 바라는 계량된 양의 혼합물이 배출공을 통해 분배될 수 있게 해주는 배출공과 밸브장치 및 혼합실을 포함하는 팩.39. The method according to any one of claims 36 to 38, which allows the first and second components to be dispensed from each chamber into the mixing chamber under pressure developed by one or more injectors, and by controlling the ratio of the components within the metered range. A pack containing a vent and valve arrangement and a mixing chamber that allows the desired metered amount of the mixture to be dispensed through the vent. 제39항 또는 40항에 있어서, 상기 밸브장치가 제1성분을 혼합실내로 공급되게 하여 혼합실을 채우고 계량된 양의 제2성분을 이들 두 성분의 난류혼합이 생길수 있도록 혼합실내에 공급해준 다음 혼합물을 배출되게 해주는 장치를 구성되어 있는 팩.41. The method as claimed in claim 39 or 40, wherein the valve device feeds the first component into the mixing chamber to fill the mixing chamber and supplies a metered amount of the second component into the mixing chamber so that turbulent mixing of these two components can occur. Pack consisting of devices which allow the mixture to be discharged. 제39항 또는 40항에 있어서 제1 및 제2실이 종단으로 배열된 각각 밸브장치를 갖고 있는 밀실로 그 사이에 혼합실이 배열되어 있는 팩.41. The pack according to claim 39 or 40, wherein the first and second chambers each have a valve arrangement in which the first and second chambers are arranged longitudinally, with the mixing chamber arranged therebetween. 제39항 또는 40항에 있어서 제1실과 제2실이 옆으로 나란히 배열된 각기 밸브장치를 가진 밀실로서 그 사이에 그 상부에 혼합실이 배치되어 있는 펙.41. The peck according to claim 39 or 40, wherein the first chamber and the second chamber each have a valve device arranged side by side, with a mixing chamber disposed therebetween. 제39항 또는 40항에 있어서 제1실과 제2실이 하나가 다른 하나 내부에 배열된 밀실로서, 밸브 장치와 혼합실이 바깥실내부나 상부에 위치해 있는 팩.41. A pack according to claim 39 or 40, wherein the first chamber and the second chamber are arranged one inside the other, with the valve arrangement and the mixing chamber located at the top or outside of the chamber. 제40항 내지 43항중 어느 하나에서, 그의 내부에 각실이 배치되어 있으며, 그를 통해 밸브장치가 작동될 수 있는 외곽하우징을 포함하는 팩.44. A pack according to any one of claims 40 to 43, wherein the chamber is disposed therein and includes an outer housing through which the valve device can be operated. 제44항에 있어서, 제2성분이 분사체를 함유하며, 내부강벽을 가진 밀실내 배치되어 있으며 제2성분이 외부 가요성-벽을 가진 밀실내 배치되어 있으며, 하우징이 강벽하우징이며, 바깥 밀실과 그를 둘러서는 하우징 사이의 공간이 분사체를 함유하 팩.45. The method of claim 44, wherein the second component contains injectors, disposed in a closed chamber with inner steel walls, and the second component is disposed in a closed chamber with outer flexible-walls, the housing being a steel wall housing, the outer closed chamber And the space between the housing surrounding it packs containing injectors. ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.※ Note: The disclosure is based on the initial application.
KR1019840004923A 1983-08-17 1984-08-16 Preparation of Aerosol Composition KR850001689A (en)

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