KR100378031B1 - 술포알킬 에테르 시클로덱스트린과 치료제의 물리적혼합물을 함유하는 솔리드형 약학적 제제 - Google Patents
술포알킬 에테르 시클로덱스트린과 치료제의 물리적혼합물을 함유하는 솔리드형 약학적 제제 Download PDFInfo
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- KR100378031B1 KR100378031B1 KR10-1999-7010182A KR19997010182A KR100378031B1 KR 100378031 B1 KR100378031 B1 KR 100378031B1 KR 19997010182 A KR19997010182 A KR 19997010182A KR 100378031 B1 KR100378031 B1 KR 100378031B1
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- KR
- South Korea
- Prior art keywords
- therapeutic agent
- cyclodextrin
- sae
- tablet
- sbe
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- 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
- A61K47/40—Cyclodextrins; 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
SAE-CD 종류 | 결합 상수 | 용해도(mg/mL) |
SBE4β | 700 | 5.62 |
SBE7β | 710 | 5.95 |
SBE11β | 960 | 6.73 |
SBE4γ | 2600 | 14.74 |
pH | SBE7β-CD 농도(M) | DP 용해도(㎍/mL) |
7.0 | 0 | 3.56 |
7.0 | 0.1 | 504 |
4.0 | 0 | 1990 |
4.0 | 0.1 | 16000 |
Claims (20)
- 하기 화학식 (I)의 술포알킬 에테르-시클로덱스트린 유도체(들)와 치료학적 유효량의 치료제의 물리적 혼합물 및 약학적으로 허용 가능한 담체를 포함하는 약학 조성물로서, 상기 치료제의 50% 이상이 상기 술포알킬 에테르-시클로덱스트린 유도체에 복합체화되지 않은 것을 특징으로 하는 약학적 조성물.화학식 (I)상기 식 중,n은 4, 5 또는 6이고,R1, R2, R3, R4, R5, R6, R7, R8및 R9는 각각 독립적으로 -O- 또는 -O-(C2-C6 알킬렌)-SO3-인데, 여기서 R1및 R2중 하나 이상은 독립적으로 -O-(C2-C6 알킬렌)-SO3-이며,S1, S2, S3, S4, S5, S6, S7, S8및 S9는 각각 독립적으로 약학적으로 허용 가능한 양이온이다.
- 삭제
- 제1항에 있어서, R1및 R2중 하나 이상은 -O-(CH2)m-SO3-이며, m은 2, 3, 4, 5 또는 6인 것을 특징으로 하는 약학적 조성물.
- 제3항에 있어서, S1, S2, S3, S4, S5, S6, S7, S8및 S9는 각각 독립적으로, 알칼리 금속 양이온, 알칼리토금속 양이온, 4차 암모늄 양이온, 3차 암모늄 양이온 및 2차 암모늄 양이온으로 이루어진 군 중에서 선택되는 것을 특징으로 하는 약학적 조성물.
- 삭제
- 제3항에 있어서, 치료제의 75% 이상이 복합체화되지 않은 것을 특징으로 하는 약학적 조성물.
- 제4항에 있어서, 치료제의 95% 이상이 복합체화되지 않은 것을 특징으로 하는 약학적 조성물.
- 하기 화학식 (I)의 술포알킬 에테르-시클로덱스트린 유도체(들)와, 약학적 담체와, 50% 이상이 술포알킬 에테르-시클로덱스트린 유도체에 복합체화되지 않은 유효량의 치료제로 이루어진 물리적 혼합물을 포함하는 솔리드형 코어를 형성시키는 단계와,상기 솔리드형 코어를 막 형성제와 공극 형성제를 포함하는 막 피복물로 피복하여 약학적으로 허용 가능한 솔리드형 투여 형태를 제공하는 단계를 포함하는 것을 특징으로 하는 술포알킬 에테르-시클로덱스트린 함유 약학적 투여 형태의 제조 방법.화학식 (I)상기 식 중,n은 4, 5 또는 6이고,R1, R2, R3, R4, R5, R6, R7, R8및 R9는 각각 독립적으로 -O- 또는 -O-(C2-C6 알킬렌)-SO3-인데, 여기서 R1및 R2중 하나 이상은 독립적으로 -O-(C2-C6 알킬렌)-SO3-이며,S1, S2, S3, S4, S5, S6, S7, S8및 S9는 각각 독립적으로 약학적으로 허용 가능한 양이온이다.
- 삭제
- 삭제
- 제8항에 있어서, 상기 화학식 (I)의 술포알킬 에테르-시클로덱스트린 유도체는 R1, R2및 R3가 각각 독립적으로 -O-(C2-C6 알킬렌)-SO3-인 것으로 정의되는 것을 특징으로 하는 제조 방법.
- 제8항에 있어서, 상기 화학식 (I)의 술포알킬 에테르-시클로덱스트린 유도체는 R4, R6및 R8중 하나 이상이 독립적으로 -O-(C2-C6 알킬렌)-SO3-이고, R5, R7및 R9는 모두 -O-인 것으로 정의되는 것을 특징으로 하는 제조 방법.
- 제8항에 있어서, 상기 화학식 (I)의 술포알킬 에테르-시클로덱스트린 유도체는 R4, R6및 R8이 각가 독립적으로 -O-(C2-C6 알킬렌)-SO3-인 것으로 정의되는 것을 특징으로 하는 제조 방법.
- 막 피복물 및 솔리드형 코어를 포함하는 솔리드형 약학적 제제로서, 상기 막 피복물은 막 형성제 및 공극 형성제를 포함하고, 상기 솔리드형 코어는 치료학적 유효량의 치료제와 술포알킬 에테르-시클로덱스트린(SAE-CD)의 물리적 혼합물 및 약학적으로 허용 가능한 담체를 포함하며, 상기 치료제의 50% 이상이 SAE-CD에 복합체화되지 않은 것을 특징으로 하는 솔리드형 약학적 제제.
- 제14항에 있어서, 상기 막 형성제는 셀룰로스 아세테이트, 에틸 셀룰로스, 메틸 셀룰로스, 왁스, 유드라기트(EUDRAGIT) E100, 유드라기트 RS, 유드라기트 RL, 유드라기트 L, 유드라기트 S, 셀룰로스 아세테이트 프탈레이트, 히드록시프로필 메틸셀룰로스 프탈레이트, 히드록시프로필 메틸셀룰로스 아세테이트 숙시네이트, 셀룰로스 아세테이트 부티레이트, 셀룰로스 아세테이트 프로피오네이트, 셀룰로스 프로피오네이트, 히드록시프로필 메틸셀룰로스, 카라기난, 셀룰로스 니트레이트, 히드록시에틸 셀룰로스, 폴리(비닐 아세테이트), 아카시아, 트라가칸트, 구아 검, 젤라틴 및 이들의 조합물로 이루어지는 군 중에서 선택되는 것을 특징으로 하는 솔리드형 약학적 제제.
- 제14항에 있어서, 상기 공극 형성제는 상기 제제가 물에 노출될 때 상기 막 피복물 내에 공극이 형성되는 것을 촉진하는 것을 특징으로 하는 솔리드형 약학적 제제.
- 제14항에 있어서, 상기 공극 형성제는 상기 막 피복물의 투수성을 증가시키는 것을 특징으로 하는 솔리드형 약학적 제제.
- 제14항에 있어서, 상기 제제는 정제, 소형 정제, 과립, 펠릿, 분말 또는 결정인 것을 특징으로 하는 솔리드형 약학적 제제.
- 제14항에 있어서, 상기 제제는 상기 치료제 및 상기 술포알킬 에테르-시클로덱스트린에 대해 지연 방출형, 지속 방출형 또는 조절 방출형 프로필을 나타내는 것을 특징으로 하는 솔리드형 약학적 제제.
- 제19항에 있어서, 상기 제제는 상기 치료제 및 상기 술포알킬 에테르-시클로덱스트린에 대해 실질적으로 동일한 방출 프로필을 나타내는 것을 특징으로 하는 솔리드형 약학적 제제.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/851,006 | 1997-05-05 | ||
US08/851,006 US5874418A (en) | 1997-05-05 | 1997-05-05 | Sulfoalkyl ether cyclodextrin based solid pharmaceutical formulations and their use |
US8/851,006 | 1997-05-05 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20010012233A KR20010012233A (ko) | 2001-02-15 |
KR100378031B1 true KR100378031B1 (ko) | 2003-04-16 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR10-1999-7010182A KR100378031B1 (ko) | 1997-05-05 | 1998-04-20 | 술포알킬 에테르 시클로덱스트린과 치료제의 물리적혼합물을 함유하는 솔리드형 약학적 제제 |
Country Status (10)
Country | Link |
---|---|
US (1) | US5874418A (ko) |
EP (1) | EP0980262B1 (ko) |
JP (1) | JP3745382B2 (ko) |
KR (1) | KR100378031B1 (ko) |
AT (1) | ATE234634T1 (ko) |
AU (1) | AU729671B2 (ko) |
CA (1) | CA2289202C (ko) |
DE (1) | DE69812343T2 (ko) |
ES (1) | ES2190075T3 (ko) |
WO (1) | WO1998050077A1 (ko) |
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1997
- 1997-05-05 US US08/851,006 patent/US5874418A/en not_active Expired - Lifetime
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- 1998-04-20 JP JP54813698A patent/JP3745382B2/ja not_active Expired - Lifetime
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DE69812343D1 (de) | 2003-04-24 |
US5874418A (en) | 1999-02-23 |
CA2289202A1 (en) | 1998-11-12 |
EP0980262B1 (en) | 2003-03-19 |
WO1998050077A1 (en) | 1998-11-12 |
AU7153598A (en) | 1998-11-27 |
JP2002503267A (ja) | 2002-01-29 |
CA2289202C (en) | 2005-03-15 |
ATE234634T1 (de) | 2003-04-15 |
EP0980262A1 (en) | 2000-02-23 |
AU729671B2 (en) | 2001-02-08 |
JP3745382B2 (ja) | 2006-02-15 |
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