KR100499320B1 - 염산 탐스로신 함유 방출 조절형 제제 - Google Patents
염산 탐스로신 함유 방출 조절형 제제 Download PDFInfo
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- KR100499320B1 KR100499320B1 KR1020040046049A KR20040046049A KR100499320B1 KR 100499320 B1 KR100499320 B1 KR 100499320B1 KR 1020040046049 A KR1020040046049 A KR 1020040046049A KR 20040046049 A KR20040046049 A KR 20040046049A KR 100499320 B1 KR100499320 B1 KR 100499320B1
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- Prior art keywords
- weight
- tamsulosin
- release
- controlled release
- drug
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- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
-
- 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
- A61K31/13—Amines
- A61K31/145—Amines having sulfur, e.g. thiurams (>N—C(S)—S—C(S)—N< and >N—C(S)—S—S—C(S)—N<), Sulfinylamines (—N=SO), Sulfonylamines (—N=SO2)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/20—Elemental chlorine; Inorganic compounds releasing chlorine
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
코팅층 | 구성성분 | 실시예 2 | 실시예 3 | 실시예 4 | 실시예 5 | 실시예 6 |
과립코어 | 슈가스피어 | 761g | 761g | 761g | 761g | 700g |
약물코팅층 | 염산 탐스로신 | 1g | 1g | 1g | 1g | 1.078g |
유드라짓 RS 30D® | 203g | 203g | 203g | 203g | 219g | |
트리에칠시트레이트 | 7.3g | 12.2g | 6.1g | 8.5g | 13.1g | |
프로필렌글리콜 | 4.9g | - | 6.1g | 3.7g | - | |
탈크 | 12.2g | 12.2g | 12.2g | 12.2g | 13.1g | |
방출제어층 | 콜리코트 SR 30D® | 116g | 93g | 145g | 113g | - |
유드라짓 RS 30D® | - | - | - | - | 200g | |
초산호박산히드록시프로필메칠셀룰로오스 | 5.2g | 7.0g | 10.9g | 8.5g | 6.0g | |
트리에칠시트레이트 | 2.8g | 3.5g | 5.4g | 3.0g | 13.2g | |
프로필렌글리콜 | 1.2g | - | - | 1.3g | - | |
탈크 | 8.0g | 7.0g | 10.9g | 8.5g | 13.2g |
Claims (7)
- (a) 과립코어,(b) (i) 에칠셀룰로오스; 히드록시에칠셀룰오스; 에칠 아크릴레이트 1 중량부, 메칠 메타아크릴레이트 2 중량부 및 트리메칠암모니오에칠 메타아크릴레이트 클로라이드 0.1 중량부의 공중합체[poly(ethyl acrylate, methyl methacrylate, trimethylammonioethyl methacrylate chloride) 1 : 2 : 0.1]; 및 폴리비닐아세테이트[poly(vinylacetate)]로 이루어진 군에서 선택된 방출조절제와 (ii) 염산 탐스로신을 포함하는, 상기 과립코어 상에 코팅된 약물코팅층,(c) (i) 에칠셀룰로오스; 히드록시에칠셀룰오스; 에칠 아크릴레이트 1 중량부, 메칠 메타아크릴레이트 2 중량부 및 트리메칠암모니오에칠 메타아크릴레이트 클로라이드 0.1 중량부의 공중합체; 및 폴리비닐아세테이트로 이루어진 군에서 선택된 방출조절제, 및 (ii) 카르복시메칠에칠셀룰로오스, 프탈산히드록시프로필메칠셀룰로오스, 초산호박산히드록시프로필메칠셀룰로오스, 초산프탈산셀룰로오스, 메타아크릴산-아크릴산에칠 공중합체, 메타아크릴산-메타아크릴산메칠 공중합체, 쉘락, 및 이들의 혼합물로 이루어진 군으로부터 선택된 장용성 채널 형성제가 상기 약물코팅층 상에 추가로 코팅된 방출제어층을 포함하는 염산 탐스로신 함유 방출 조절형 제제.
- 제1항에 있어서, 상기 약물코팅층 중의 염산 탐스로신 및 방출조절제의 중량비가 1 : 10 내지 1 : 200인 것을 특징으로 하는 염산 탐스로신 함유 방출 조절형 제제.
- 제1항에 있어서, 상기 방출제어층 중의 상기 방출조절제의 함량이 염산 탐스로신 1 중량부에 대하여 30 내지 100 중량부인 것을 특징으로 하는 염산 탐스로신 함유 방출 조절형 제제.
- 제1항에 있어서, 상기 방출제어층 중의 상기 장용성 채널 형성제의 함량이 염산 탐스로신 1 중량부에 대하여 5 내지 30 중량부인 것을 특징으로 하는 염산 탐스로신 함유 방출 조절형 제제.
- 제1항 내지 제4항 중 어느 한 항에 있어서, 상기 방출조절제가 에칠 아크릴레이트 1 중량부, 메칠 메타아크릴레이트 2 중량부 및 트리메칠암모니오에칠 메타아크릴레이트 클로라이드 0.1 중량부의 공중합체 또는 폴리비닐아세테이트인 것을 특징으로 하는 염산 탐스로신 함유 방출 조절형 제제.
- 제1항 내지 제4항 중 어느 한 항에 있어서, 상기 장용성 채널 형성제가 초산호박산히드록시프로필메칠셀룰로오스인 것을 특징으로 하는 염산 탐스로신 함유 방출 조절형 제제.
- 제5항에 있어서, 상기 장용성 채널 형성제가 초산호박산히드록시프로필메칠셀룰로오스인 것을 특징으로 하는 염산 탐스로신 함유 방출 조절형 제제.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020040046049A KR100499320B1 (ko) | 2004-06-21 | 2004-06-21 | 염산 탐스로신 함유 방출 조절형 제제 |
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KR1020040046049A KR100499320B1 (ko) | 2004-06-21 | 2004-06-21 | 염산 탐스로신 함유 방출 조절형 제제 |
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Publication Number | Publication Date |
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KR100499320B1 true KR100499320B1 (ko) | 2005-07-04 |
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KR1020040046049A KR100499320B1 (ko) | 2004-06-21 | 2004-06-21 | 염산 탐스로신 함유 방출 조절형 제제 |
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KR (1) | KR100499320B1 (ko) |
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2004
- 2004-06-21 KR KR1020040046049A patent/KR100499320B1/ko active IP Right Grant
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