KR101074936B1 - 도세탁셀 주사제용 조성물 및 그의 제조방법 - Google Patents
도세탁셀 주사제용 조성물 및 그의 제조방법 Download PDFInfo
- Publication number
- KR101074936B1 KR101074936B1 KR1020090045356A KR20090045356A KR101074936B1 KR 101074936 B1 KR101074936 B1 KR 101074936B1 KR 1020090045356 A KR1020090045356 A KR 1020090045356A KR 20090045356 A KR20090045356 A KR 20090045356A KR 101074936 B1 KR101074936 B1 KR 101074936B1
- Authority
- KR
- South Korea
- Prior art keywords
- docetaxel
- composition
- polysorbate
- solution
- injectable composition
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (9)
- 약리활성성분으로 도세탁셀, 가용화제로 폴리옥시에틸렌 솔비탄 지방산 에스테르(폴리솔베이트) 및 안정화제로 젖산(lactic acid)을 중량비 5.2 : 135.2 : 0.41로 포함하며 에탄올을 포함하지 않는 도세탁셀 주사제용 조성물.
- 제 1 항에 있어서, 도세탁셀이 무수의 도세탁셀 또는 도세탁셀 삼수화물인 도세탁셀 주사제용 조성물.
- 제 1 항에 있어서, 폴리솔베이트가 폴리솔베이트 80인 도세탁셀 주사제용 조성물.
- 제 1 항 내지 제3항 중 어느 한 항에 있어서, 조성물의 pH가 3.0 내지 4.5인 도세탁셀 주사제용 조성물.
- 제 4 항에 있어서, 도세탁셀이 조성물의 총 중량 대비 1 내지 5중량% 함유된 것인 도세탁셀 주사제용 조성물.
- 제 4 항에 있어서, 도세탁셀이 36 내지 44 mg/mL으로 함유된 것인 도세탁셀 주사제용 조성물.
- 제 4 항에 있어서, 폴리옥시에틸렌 솔비탄 지방산 에스테르(폴리솔베이트)가 800 내지 1200 mg/mL으로 함유된 것인 도세탁셀 주사제용 조성물.
- 제 4 항에 있어서, 젖산이 조성물의 총 중량 대비 0.25 내지 0.35 중량%로 함유되는 도세탁셀 주사제용 조성물.
- 삭제
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020090045356A KR101074936B1 (ko) | 2009-05-25 | 2009-05-25 | 도세탁셀 주사제용 조성물 및 그의 제조방법 |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020090045356A KR101074936B1 (ko) | 2009-05-25 | 2009-05-25 | 도세탁셀 주사제용 조성물 및 그의 제조방법 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20100126924A KR20100126924A (ko) | 2010-12-03 |
KR101074936B1 true KR101074936B1 (ko) | 2011-10-18 |
Family
ID=43504321
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020090045356A KR101074936B1 (ko) | 2009-05-25 | 2009-05-25 | 도세탁셀 주사제용 조성물 및 그의 제조방법 |
Country Status (1)
Country | Link |
---|---|
KR (1) | KR101074936B1 (ko) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JO3685B1 (ar) * | 2012-10-01 | 2020-08-27 | Teikoku Pharma Usa Inc | صيغ التشتيت الجسيمي للتاكسين غير المائي وطرق استخدامها |
CN117177737A (zh) * | 2023-05-06 | 2023-12-05 | 北京德立英捷医药科技有限公司 | 可自乳化的多西他赛注射用组合物及其制备方法 |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008026048A2 (en) * | 2006-08-31 | 2008-03-06 | Wockhardt Research Centre | Stable injectable pharmaceutical compositions of docetaxel |
WO2008087076A1 (en) * | 2007-01-17 | 2008-07-24 | Sandoz Ag | Pharmaceutical composition of improved stability containing taxane derivatives |
-
2009
- 2009-05-25 KR KR1020090045356A patent/KR101074936B1/ko active IP Right Grant
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008026048A2 (en) * | 2006-08-31 | 2008-03-06 | Wockhardt Research Centre | Stable injectable pharmaceutical compositions of docetaxel |
WO2008087076A1 (en) * | 2007-01-17 | 2008-07-24 | Sandoz Ag | Pharmaceutical composition of improved stability containing taxane derivatives |
Also Published As
Publication number | Publication date |
---|---|
KR20100126924A (ko) | 2010-12-03 |
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