KR20000068171A - 에어로졸 약제성분 - Google Patents
에어로졸 약제성분 Download PDFInfo
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- KR20000068171A KR20000068171A KR1019997001274A KR19997001274A KR20000068171A KR 20000068171 A KR20000068171 A KR 20000068171A KR 1019997001274 A KR1019997001274 A KR 1019997001274A KR 19997001274 A KR19997001274 A KR 19997001274A KR 20000068171 A KR20000068171 A KR 20000068171A
- Authority
- KR
- South Korea
- Prior art keywords
- aerosol
- composition
- mmad
- low volatility
- hfa
- Prior art date
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- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 description 1
- 235000010449 maltitol Nutrition 0.000 description 1
- 229940035436 maltitol Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
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- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 229940071648 metered dose inhaler Drugs 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- NJTGANWAUPEOAX-UHFFFAOYSA-N molport-023-220-454 Chemical compound OCC(O)CO.OCC(O)CO NJTGANWAUPEOAX-UHFFFAOYSA-N 0.000 description 1
- IJDNQMDRQITEOD-UHFFFAOYSA-N n-butane Chemical compound CCCC IJDNQMDRQITEOD-UHFFFAOYSA-N 0.000 description 1
- 230000003472 neutralizing effect Effects 0.000 description 1
- 229940038384 octadecane Drugs 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 210000003300 oropharynx Anatomy 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 150000003904 phospholipids Chemical class 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 239000011118 polyvinyl acetate Substances 0.000 description 1
- 229920002689 polyvinyl acetate Polymers 0.000 description 1
- 229920002451 polyvinyl alcohol Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 239000001294 propane Substances 0.000 description 1
- HNJBEVLQSNELDL-UHFFFAOYSA-N pyrrolidin-2-one Chemical compound O=C1CCCN1 HNJBEVLQSNELDL-UHFFFAOYSA-N 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 235000019204 saccharin Nutrition 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 229940081974 saccharin Drugs 0.000 description 1
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 229920006395 saturated elastomer Polymers 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
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- 235000007586 terpenes Nutrition 0.000 description 1
- 231100001274 therapeutic index Toxicity 0.000 description 1
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- 229930003799 tocopherol Natural products 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays 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]
-
- 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
Abstract
Description
BDP10㎎/10㎖에타놀 7.9% | BDP10㎎/10㎖에타놀12.9-13.0% | BDP20㎎/10㎖에타놀 7.9% | BDP20㎎/10㎖에타놀 13.0% | |
평균방사도스량(㎍) | 44.7 | 45.1 | 84.8 | 87.6 |
미립도스량(㎍) | 31.1 | 24.5 | 63.1 | 46.2 |
MMAD ± GSD | 0.8±1.8 | 0.9±2.0 | 1.0±1.8 | 1.0±1.9 |
쇼트(shot)중량(㎎) | 59.0 | 58.7 | 59.1 | 57.6 |
복제수(replications) | 6 | 2 | 6 | 2 |
BDP10㎎/10㎖에타놀 13.7%H2O 0.1% | BDP10㎎/10㎖에타놀 13.6%H2O 0.5% | BDP50㎎/10㎖에타놀 14.9%H2O 0.1% | BDP50㎎/10㎖에타놀 14.9%H2O 0.5% | |
평균방사도스량(㎍) | 43.2 | 42.9 | 222.1 | 215.1 |
미립도스량(㎍) | 14.9 | 12.7 | 67.4 | 60.2 |
MMAD ± GSD | 1.0±2.2 | 1.0±2.1 | 1.8±2.2 | 1.7±2.2 |
쇼트(shot)중량(㎎) | 58.1 | 58.0 | 59.0 | 57.5 |
복제수(replications) | 6 | 6 | 6 | 6 |
처방 | CFC-IPBr | HFA134a/에타놀25%-IPBr** | HFA134a-IPBr* | ||
글리세롤함량(%) | 0 | 0 | 0.5 | 1.0 | |
평균방사도스량(㎍) | 18.8 | 17.1 | 16.1 | 18.7 | 18.8 |
미립도스량(㎍) | 6.1 | 2.6 | 3.9 | 6.9 | 5.6 |
MMAD ± GSD | 2.8±1.8 | 1.3±2.0 | 1.2±1.9 | 1.9±2.0 | 2.5±2.1 |
쇼트(shot)중량(㎎) | 75.4 | 55.7 | 58.0 | 59.0 | 58.3 |
복제수(replications) | 3 | 4 | 6 | 6 | 6 |
프로필렌 글리콜 함량 | ||||
0.0%(w/w) | 1.1%(w/w) | 3.2%(w/w) | 6.8%(w/w) | |
평균방사도스량(㎍) | 41.8 | 44.0 | 43.6 | 44.9 |
미립도스량(㎍) | 10.3 | 9.3 | 7.3 | 4.9 |
MMAD ± GSD | 1.1±2.3 | 1.6±3.4 | 2.9±4.1 | 4.6±3.9 |
복제수(replications) | 2 | 6 | 6 | 6 |
프로필렌 글리콜 함량 | ||||
0.0%(w/w) | 0.7%(w/w) | 2.8%(w/w) | 6.3%(w/w) | |
평균방사도스량(㎍) | 209.1 | 218.4 | 204.2 | 242.6 |
미립도스량(㎍) | 41.6 | 41.1 | 32.1 | 25.2 |
MMAD ± GSD | 1.7±2.3 | 2.1±2.7 | 3.3±3.2 | 4.4±3.8 |
복제수(replications) | 3 | 3 | 3 | 3 |
글리세롤 함량 | ||||
0.0%(w/w) | 1.0%(w/w) | 1.3%(w/w) | 1.6%(w/w) | |
평균방사도스량(㎍) | 205.8 | 218.3 | 220.8 | 228.0 |
미립도스량(㎍) | 105.9 | 94.4 | 100.3 | 296.6 |
MMAD ± GSD | 1.4±1.9 | 2.4±2.0 | 2.6±2.0 | 2.7±2.0 |
복제수(replications) | 6 | 3 | 3 | 2 |
글리세롤 함량 | ||||
0.0%(w/w) | 1.0%(w/w) | 1.3%(w/w) | 1.6%(w/w) | |
평균방사도스량(㎍) | 222.1 | 227.9 | 228.4 | 2231.7 |
미립도스량(㎍) | 67.4 | 55.9 | 54.3 | 50.9 |
MMAD ± GSD | 1.8±2.2 | 2.8±2.2 | 3.1±2.3 | 3.1±2.3 |
복제수(replications) | 6 | 4 | 3 | 2 |
PEG 400 PEG 8000 | |||
1.1%(w/w) | 1.0%(w/w) | 0.0%(w/w) | |
평균방사도스량(㎍) | 218.9 | 215.0 | 222.1 |
미립도스량(㎍) | 55.6 | 55.6 | 67.4 |
MMAD ± GSD | 2.5±2.2 | 2.5±2.2 | 1.8±2.2 |
복제수(replications) | 2 | 1 | 6 |
멘톨%(w/w) | 글리세롤%(w/w) | 미립도스량(㎍) | MMAD | GSD | 방사도스량(㎍) | 복제수(n) |
0 | 0 | 76.85 | 1.8 | 2.15 | 217.1 | 2 |
0.4 | 0.9 | 77.84 | 2.9 | 2.1 | 221.6 | 5 |
글리세롤%(w/w) | 올레인산%(w/w) | 방사도스량(㎍) | FPD(㎍) | MMAD(㎛) | GSD | 복제수(n) |
0 | 0.35 | 85.8 | 29.1 | 1.7 | 2.3 | 1 |
1.3 | 0.36 | 92.0 | 25.2 | 2.8 | 2.4 | 1 |
글리세롤%(w/w) | 올레인산%(w/w) | BDP | 살부타몰기 | 활성오리피스(mm) | n | ||||||
방사도스량(㎍) | FPD(㎍) | MMAD(㎛) | GSD | 방사도스량(㎍) | FPD(㎍) | MMAD(㎛) | GSD | ||||
0 | 0 | 208.9 | 67.8 | 1.7 | 2.4 | 82.5 | 26.9 | 1.7 | 2.2 | 0.33 | 2 |
0 | 0.3 | 212.7 | 60.6 | 2.2 | 2.3 | 84.8 | 24.0 | 2.0 | 2.6 | 0.33 | 2 |
0 | 1.3 | 212.5 | 58.5 | 2.4 | 2.2 | 85.9 | 23.9 | 2.4 | 2.1 | 0.30 | 1 |
1.2 | 0.3 | 210.8 | 63.3 | 2.9 | 2.1 | 85.3 | 25.1 | 3.0 | 2.0 | 0.30 | 1 |
HFA 227 | ||
0산%(w/w)글리세롤 | 1.42산%(w/w) 글리세롤 | |
FPD(㎍) | 62.1 | 43.5 |
MMAD(㎛) | 2.2 | 4.1 |
GSD | 2.6 | 2.4 |
평균방사도스량(㎍) | 221.25 | 230.5 |
복제수 | 2 | 2 |
Claims (23)
- 에어로졸 흡입기(aerosol inbaler)에 사용하는 조성물은, 활성재료(active material), 촉진제로 구성되고 이 촉진제는 하이드로 플루오로알칸(hydrofluoroalkane : HFA), 코솔벤트로 이루어지며, 또한 저휘발성 성분을 추가로 구성하므로써 흡입기의 활성화에 에어로졸 입자의 매스 메디안 공기역학적 직경(mass median aerodynamic dimeter : MMAD)을 증가시키도록 한 약제 에어로졸 조성(pharmaceutical aerosol composition)
- 제 1항에 있어서, 상기 저휘발성 성분은 25℃에서 0.1KPa 를 넘지않는 증기압을 가지는 약제에어로졸 조성
- 제 2항에 있어서, 상기 저휘발성 성분은 25℃에서 0.05KPa 를 넘지않는 증기압을 가지는 약제에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 코솔벤트는 25℃에서 3KPa 를 넘지않는 증기압을 가지는 약제에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 코솔벤트는 25℃에서 5KPa 를 넘지않는 증기압을 가지는 약제에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 코솔벤트는 알콜로 되는 약제에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 저휘발성 성분은 글리콜(glycol)을 함유하는 약제에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 저휘발성 성분은 올레인산(oleic acid)을 함유하는 약제에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 촉진제는 HFA 134a및 HFA 227 을 구성하는 군으로부터 선택되는 하나 이상의 HFAs를 함유하는 약제 에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 조성은 저휘발성 성분의 중량의 20% 이하를 함유하는 약제 에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 조성은 저휘발성 성분의 중량의 0.2% 이상을 함유하는 약제 에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 조성은 사용중에 있는 에어로졸 흡입기의 활성화에 있어 에어로졸 입자의 MMAD가 2㎛ 이상 되도록 한 약제 에어로졸 조성
- 앞서의 전항중 어느 하나의 항에 있어서, 상기 조성은 용액의 형태로 이루어지도록 한 약제 에어로졸 조성
- 에어로졸 흡입기용 조서에 있어 저휘발성 성분의 사용은 이 조성이 활성재료, 촉진제로 이루어지고 이 촉진제는 하이드로 플루오로-알칸(HFA) 및 코솔벤트로 구성되므로써 상기 흡입기의 활성화에서의 에어로졸 입자의 매스 메디언 공기역학적 직경(MMAD)을 증가시키도록 하는 저휘발성 성분의 용도(use of a low volatility component)
- 제 14항에 있어서, 상기 저휘발성 성분의 사용은 에어로졸 입자의 MMAD가 2㎛이상 되도록 하여주는 저휘발성 성분의 용도
- 제 14항 또는 제 15항에 있어서, 상기 저휘발성 성분은 그 증기압이 25℃에서 0.1KPa 를 넘지 않도록 한 저휘발성 성분의 용도
- 제 14항 내지 제 16항중 어느 하나의 항에 있어서, 상기 조성은 제 1∼13항 중 어느 하나의 항에서 청구한 조성으로 되도록 한 저휘발성 성분의 용도
- 제 1∼13항 중 어느 하나의 항에서 청구된 조성을 함유하는 에어로졸 흡입기(An aerosol inhaler)
- 조성으로 에어로졸 흡입기를 채우는 방법은 다음의 성분을 흡입기 속으로 채우고 다음 하이드로 플루오로알칸(HFA)을 함유하는 촉진제에 첨가가 뒤따르는 에어로졸 흡입기 충전방법a. 하나 이상의 활성화재료b. 하나 이상의 저휘발성 성분c. 하나 이상의 코솔벤트
- 제 19항에 있어서, 상기 조성은 제 1∼13항 중 어느 하나의 항에서 청구되는 조성이 되도록 한 에어로졸 흡입기 충전방법
- 에어로졸 흡입기로 부터 방사되는 에어로졸 입자는 활성화 성분, 하이드로 플루오로-알칸(HFA)을 함유하는 촉진제, 코솔벤트 및 저휘발성 성분을 함유하는 조성으로 이루어지고, 여기에서 에어로졸 입자의 매스 메디언 공기역학적 직경(MMAD)은 2㎛ 이상이 되는 에어로졸 입자(Aerosol particle)
- 제 21항에 있어서, 상기 입자의 MMAD는 2.5㎛ 이상이 되는 에어로졸 입자
- 제 21항 또는 제 22항에 있어서, 상기 조성은 청구항 제 1∼13항중 어느 하나의 항에서 청구된 조성으로 되는 에어로졸 입자
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB9712434,1 | 1997-06-13 | ||
GB9712434A GB2326334A (en) | 1997-06-13 | 1997-06-13 | Pharmaceutical aerosol compositions |
Publications (2)
Publication Number | Publication Date |
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KR20000068171A true KR20000068171A (ko) | 2000-11-25 |
KR100546239B1 KR100546239B1 (ko) | 2006-01-26 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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KR1019997001274A KR100546239B1 (ko) | 1997-06-13 | 1998-06-10 | 약제 에어로졸 조성물 |
Country Status (45)
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR101113003B1 (ko) * | 2003-03-20 | 2012-02-24 | 베링거 인겔하임 파마슈티칼즈, 인코포레이티드 | 추진제로 하이드로-플루오로-알칸을 사용하는 계량 흡입기용 제형 |
Families Citing this family (34)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
GB9616237D0 (en) | 1996-08-01 | 1996-09-11 | Norton Healthcare Ltd | Aerosol formulations |
US20010031244A1 (en) | 1997-06-13 | 2001-10-18 | Chiesi Farmaceutici S.P.A. | Pharmaceutical aerosol composition |
IT1303788B1 (it) | 1998-11-25 | 2001-02-23 | Chiesi Farma Spa | Formulazioni di aerosol medicinali. |
DZ2947A1 (fr) | 1998-11-25 | 2004-03-15 | Chiesi Farma Spa | Inhalateur à compteur de dose sous pression. |
IT1313553B1 (it) | 1999-07-23 | 2002-09-09 | Chiesi Farma Spa | Formulazioni ottimizzate costituite da soluzioni di steroidi dasomministrare per inalazione. |
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KR101113003B1 (ko) * | 2003-03-20 | 2012-02-24 | 베링거 인겔하임 파마슈티칼즈, 인코포레이티드 | 추진제로 하이드로-플루오로-알칸을 사용하는 계량 흡입기용 제형 |
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