KR100680574B1 - 속방성 및 서방성 약물 모두를 송달하는 경구 투약 형태의제조방법 - Google Patents
속방성 및 서방성 약물 모두를 송달하는 경구 투약 형태의제조방법 Download PDFInfo
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- KR100680574B1 KR100680574B1 KR1020047011934A KR20047011934A KR100680574B1 KR 100680574 B1 KR100680574 B1 KR 100680574B1 KR 1020047011934 A KR1020047011934 A KR 1020047011934A KR 20047011934 A KR20047011934 A KR 20047011934A KR 100680574 B1 KR100680574 B1 KR 100680574B1
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- drug
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- sustained release
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
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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
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
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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
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Diabetes (AREA)
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- Obesity (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (10)
- 경구 섭취시 즉각 방출에 의해 제 1 약물을 송달하고, 섭취 1시간후 상기 제 2 약물의 적어도 40%를 방출되지 않은 채로 남기기에 충분히 느린 위액으로의 방출 속도로 정의된 지속 방출에 의해 제 2 약물을 송달하며, 상기 제 1 약물은 물에 조금 녹거나(sparingly soluble) 불용성이고 상기 제 1 약물 대 상기 제 2 약물의 중량비는 0.01:1 이하인 약학 정제의 제조 방법으로서,고체 기질에서 제 2 약물을 분산시켜, 상기 제 2 약물이 전부 방출될 때까지 상기 고체 기질의 덩어리의 부분 또는 전체를 응집체로서 보유하면서, 위액에 침지시 지속 방출에 의해 상기 제 2 약물을 방출하는 단일 코어를 형성하는 단계,상기 제 2 약물에 대해 상기 중량비를 달성하기 위해 선택된 상당량의 상기 제 1 약물을 사용하여, 상기 단일 코어의 표면위에 직경이 10 미크론 이하인 상기 제 1 약물의 입자들의 수성 현탁액을 부착시키는 단계, 및그렇게 부착된 상기 수성 현탁액으로부터 물을 증발시켜 상기 단일 코어를 싸고 상기 제 1 약물을 함유하는 고체 껍질을 남기는 단계를 포함하는 것을 특징으로 하는 약학 정제의 제조 방법.
- 경구 섭취시 즉각 방출에 의해 제 1 약물을 송달하고, 섭취 1시간후 제 2 약물의 적어도 40%를 방출되지 않은 채로 남기기에 충분히 느린 위액으로의 방출 속도로 정의된 지속 방출에 의해 상기 제 2 약물을 송달하며, 상기 제 1 약물은 물에 조금 녹거나 불용성이고 상기 제 1 약물 대 상기 제 2 약물의 중량비는 0.01:1 이하인 약학 정제의 제조 방법으로서,제 2 약물을, 응집체로 형성되고 위액에 침지될 때, 상기 제 2 약물이 전부 방출될 때까지 상기 제 1 고체 기질의 덩어리의 부분 또는 전체를 응집체로서 보유하면서 지속 방출에 의해 상기 제 2 약물을 방출하는 물질인 제 1 고체 기질과 조합시켜 서방성 층을 형성하는 단계,상기 중량비를 달성하기 위해 선택된 제 1 및 제 2 약물의 양을 사용하여, 직경 10 미크론 이하의 상기 제 1 약물의 입자들을, 위액에 침지되는 즉시 분리성 기질 입자들로 분리되는 물질인 제 2 고체 기질의 입자들과 조합하여 층상 정제로서 상기 서방성 층에 인접한 속방성 층을 형성하는 단계를 포함하는 것을 특징으로 하는 약학 정제의 제조 방법.
- 제 1항 또는 제 2항에 있어서, 상기 제 1 약물의 상기 입자들이 0.3 미크론 내지 10 미크론의 직경인 것을 특징으로 하는 방법.
- 제 1항 또는 제 2항에 있어서, 상기 제 1 약물은 37℃에서 2중량% 미만의 물에서의 용해도를 갖는 것을 특징으로 하는 방법.
- 제 1항 또는 제 2항에 있어서, 상기 제 1 약물은 술포닐 우레아이고 상기 제 2 약물은 메트포르민 염산염, 반코마이신 염산염, 캅토프릴, 에리트로마이신 락토비오네이트, 라니티딘 염산염, 세르트랄린 염산염, 티클로피딘 염산염, 아목시실린, 세푸록심 악세틸, 세파클러, 클린다마이신, 독시플루리딘, 트라마돌, 플루옥시틴 염산염, 시프로플록사신, 간시클로버, 부프로피온, 리시노프릴, 세파클러, 시프로플록사신, 사귀나비어, 리토나비어, 넬피나비어, 클라리트로마이신, 아지트로마이신, 세프타지딘, 시클로스포린, 디곡신, 파클리탁셀, 철 염, 토피라메이트, 및 케토코나졸로 구성되는 군으로부터 선택된 일원인 것을 특징으로 하는 방법.
- 제 1항 또는 제 2항에 있어서, 상기 제 1 약물은 글리메피리드, 글리부리드, 및 글리피지드로 구성되는 군으로부터 선택된 술포닐우레아이고, 상기 제 2 약물은 메트포르민 염산염인 것을 특징으로 하는 방법.
- 제 1항 또는 제 2항에 있어서, 상기 제 1 약물은 글리메피리드이고 상기 제 2 약물은 메트포르민 염산염인 것을 특징으로 하는 방법.
- 제 1항 또는 제 2항에 있어서, 상기 고체 기질은 폴리(에틸렌 옥사이드), 히드록시프로필 메틸 셀룰로스, 및 폴리(에틸렌 옥사이드)와 히드록시프로필 메틸 셀룰로스의 조합으로 구성되는 군으로부터 선택된 일원인 것을 특징으로 하는 방법.
- 제 1항에 있어서, 상기 수성 현탁액은 그 안에 용해된 현탁제를 갖는 것을 특징으로 하는 방법.
- 제 2항에 있어서, 상기 제 2 고체 기질은 락토오스, 미정질 셀룰로스, 및 락토오스와 미정질 셀룰로스의 조합으로 구성되는 군으로부터 선택된 일원인 것을 특징으로 하는 방법.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/066,146 | 2002-02-01 | ||
US10/066,146 US6682759B2 (en) | 2002-02-01 | 2002-02-01 | Manufacture of oral dosage forms delivering both immediate-release and sustained-release drugs |
PCT/US2003/002809 WO2003066028A1 (en) | 2002-02-01 | 2003-01-28 | Manufacture of oral dosage forms delivering both immediate-release and sustained-release drugs |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20040079980A KR20040079980A (ko) | 2004-09-16 |
KR100680574B1 true KR100680574B1 (ko) | 2007-02-08 |
Family
ID=27658647
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020047011934A KR100680574B1 (ko) | 2002-02-01 | 2003-01-28 | 속방성 및 서방성 약물 모두를 송달하는 경구 투약 형태의제조방법 |
Country Status (11)
Country | Link |
---|---|
US (1) | US6682759B2 (ko) |
EP (1) | EP1469838A4 (ko) |
JP (1) | JP2005521674A (ko) |
KR (1) | KR100680574B1 (ko) |
AU (1) | AU2003207755B2 (ko) |
CA (1) | CA2417686C (ko) |
IL (1) | IL163205A (ko) |
MX (1) | MXPA04007371A (ko) |
NZ (1) | NZ534312A (ko) |
TW (1) | TWI280141B (ko) |
WO (1) | WO2003066028A1 (ko) |
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- 2003-01-28 WO PCT/US2003/002809 patent/WO2003066028A1/en active Application Filing
- 2003-01-28 AU AU2003207755A patent/AU2003207755B2/en not_active Ceased
- 2003-01-28 EP EP03705993A patent/EP1469838A4/en not_active Withdrawn
- 2003-01-28 NZ NZ534312A patent/NZ534312A/en not_active IP Right Cessation
- 2003-01-28 KR KR1020047011934A patent/KR100680574B1/ko active IP Right Grant
- 2003-01-28 MX MXPA04007371A patent/MXPA04007371A/es active IP Right Grant
- 2003-01-30 CA CA002417686A patent/CA2417686C/en not_active Expired - Fee Related
- 2003-01-30 TW TW092102293A patent/TWI280141B/zh not_active IP Right Cessation
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WO2016108507A3 (ko) * | 2014-12-31 | 2016-08-25 | 건일제약 주식회사 | 멜라토닌 및 설트랄린을 포함하는 경구용 복합정제 |
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EP1469838A1 (en) | 2004-10-27 |
JP2005521674A (ja) | 2005-07-21 |
EP1469838A4 (en) | 2009-03-25 |
CA2417686C (en) | 2006-06-06 |
IL163205A (en) | 2009-07-20 |
TWI280141B (en) | 2007-05-01 |
AU2003207755A1 (en) | 2003-09-02 |
US6682759B2 (en) | 2004-01-27 |
AU2003207755B2 (en) | 2006-10-12 |
CA2417686A1 (en) | 2003-08-01 |
KR20040079980A (ko) | 2004-09-16 |
TW200302743A (en) | 2003-08-16 |
MXPA04007371A (es) | 2004-11-26 |
US20030147952A1 (en) | 2003-08-07 |
WO2003066028A1 (en) | 2003-08-14 |
NZ534312A (en) | 2006-02-24 |
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