KR101078636B1 - 약학 활성원의 지연 및 조절된 방출을 위한 생약 미세입자구강 제제 - Google Patents
약학 활성원의 지연 및 조절된 방출을 위한 생약 미세입자구강 제제 Download PDFInfo
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Abstract
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Claims (21)
- 페린도프릴을 제외한 하나 이상의 활성원 (AP)의 지연 및 조절된 방출을 위한 구강 미세입자 약학 형태로서, 상기 AP(활성원)은 생체 내에서의 흡수창이 상부위장관에 본질적으로 제한된 것으로, 상기 형태는 하기를 특징으로 하고:- AP(활성원)의 방출은, 하나는 pH의 변이에 기초한 것이며 다른 하나는 위 내에서 미리 결정된 체류 시간 이후 AP(활성원)의 방출을 가능하게 하는 것인, 2개의 상이한 개시 기작에 의해 결정되며,- 그리고, 그의 생체 밖에서의 용해 양태 (European Pharmacopeia, 3판, 제목 'Dissolution test for solid oral forms'에 제시된 바와 같이 측정함; SINK 조건 하에서 37℃에서 유지하며, 100rpm으로 교반하며 Type II dissolutest 시행)는 하기와 같음;- 일정 pH 1.4에서, 용해 프로필은, 5시간 이하의 기간의 잠복 상태를 포함함,- 그리고, 잠복 상태 동안의 pH 1.4에서 6.8 로의 변화는, 잠복기 없이 시작하는 방출 상태를 낳음,및 하기를 특징으로 하며,일정한 pH 1.4에서, 잠복 상태 이후의 조절된 방출 상태는, AP(활성원)의 50% 방출 시간 (t1/2)이 하기 (시간)로 정의됨;0.25 ≤ t1/2 ≤ 35,아울러 하기를 특징으로 하는 약학 형태:페린도프릴을 제외한 하나 이상의 활성원 (AP)을 함유하는 미세 캡슐의 '저장고'를 포함하고, 상기 미세캡슐은 하기의 타입이며:◆ 하나 이상의 필름으로 각각 코팅된 AP(활성원)의 입자로 이루어지며, 이러한 코팅 필름은 하기와 같은 복합 물질로 이루어지고:- (메트)아크릴산/알킬 (메트)아크릴레이트 코폴리머 및 이들의 혼합물,- 셀룰로스 유도체,- 및 이들의 혼합물,- 상호 혼합물 또는 단독으로의 식물 왁스;- 상호 혼합물 또는 단독으로의 수소화 식물 왁스,- 하나 이상의 지방산과의 글리세롤의 트리에스터,- 하나 이상의 지방산과의 글리세롤의 모노에스터 및 트리에스터의 혼합물,- 하나 이상의 지방산과의 글리세롤의 디에스터 및 트리에스터의 혼합물,- 하나 이상의 지방산과의 글리세롤의 모노에스터, 디에스터 및 트리에스터의 혼합물,- 및 이들의 혼합물;◆ 그리고, 2000 마이크론 미만의 직경을 가짐,이들의 코팅 필름은 하기와 같은 친수성 폴리머 A 및 소수성 화합물 B에 기초한 복합물로 이루어짐을 특징으로 함:→ 소수성 화합물 B/친수성 폴리머 A의 중량비는 0.5-1.5이며,→ 그리고 소수성 화합물 B는 고체 상태에서 결정성이고 융점 TfB가 40℃이상인 제품으로부터 선택됨.
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- 제 1 항에 있어서, 잠복기 없이 발생하는 pH 1.4에서 pH 6.8로의 변이에 따른 방출 상태는, AP(활성원)의 50% 방출 시간 (t1/2)이 하기 (시간)로 정의됨을 특징으로 하는 약학 형태;0.25 ≤ t1/2 ≤ 20.
- 제 1 항 또는 제 6 항에 있어서, 상이한 지연 및 조절 방출 프로필을 갖는 미세캡슐의 혼합물을 포함하여, 하나 이상의 방출파를 나타내는 방출 프로필을 생성함을 특징으로 하는 약학 형태.
- 제 1 항 또는 제 6 항에 있어서, 상이한 지연 및 조절 방출 프로필을 갖는 미세캡슐의 혼합물을 포함하여, 상이한 분획을 조절함으로써 AP(활성원) 혈장 농도 수준을 일정하게 보장함을 특징으로 하는 약학 형태.
- 제 1 항 또는 제 6 항에 있어서, 생체에서 즉각적으로 사용될 수 있는 양의 AP(활성원)과 미세캡슐의 혼합물을 포함함을 특징으로 하는 약학 형태.
- 제 1 항에 있어서, 미세캡슐이 단일 복합 코팅 필름을 함유함을 특징으로 하는 약학 형태.
- 제 1 항 또는 제 6 항에 있어서, AP(활성원)이, 200-800 마이크론의 직경을 가지는 중성 핵에 침착됨을 특징으로 하는 약학 형태.
- 제 11 항에 있어서, 중성 핵이-슈크로스, 또는-덱스트로스, 또는-락토스, 또는-슈크로스 및 덱스트로스, 또는-슈크로스 및 락토스, 또는-덱스트로스 및 락토스, 또는-슈크로스, 덱스트로스 및 락토스를 함유함을 특징으로 하는 약학 형태.
- 제 11 항에 있어서, 중성 핵이 셀룰로스 미세구임을 특징으로 하는 약학 형태.
- 제 1 항 또는 제 6 항에 있어서, 사용된 AP(활성원)은 하기의 활성 물질 패밀리 중 하나 이상에 속함을 특징으로 하는 약학 형태: 항궤양제, 항당뇨제, 항응집제, 항트롬빈제, 저지혈증제, 항부정맥제, 혈관팽창제, 항편도염제, 항고혈압제, 혈관보호제, 임신촉진제, 분만 유도제 및 억제제, 피임제, 항생제, 항진균제, 항바이러스제, 항암제, 항감염제, 마취제, 항발작제, 항파킨슨제, 신경이완제, 최면제, 불안제거제, 신경흥분제, 항편두통제, 항우울제, 항해소제, 항히스타민제 및 항알러지제.
- 제 14 항에 있어서, AP(활성원)은 하기의 화합물들로부터 선택됨을 특징으로 하는 약학 형태: 아목시실린, 메트포르민, 아세틸살리실산, 펜톡시필린, 프라조신, 아시클로비어, 니페디핀, 딜티아젬, 나프록센, 아이뷰프로펜, 플루비프로펜, 케토프로펜, 페노프로펜, 인도메타신, 디클로페낙, 펜티아작, 에스트라디올 발레레이트, 메토프롤롤, 설피라이드, 캅토프릴, 시메티딘, 지도부딘, 니카르디핀, 테르페나딘, 아테놀롤, 살뷰타몰, 카르바마제핀, 라니티딘, 에날라프릴, 심바스타틴, 플루옥세틴, 알프라졸람, 파모티딘, 잔시클로비어, 팜시클로비어, 스피로노락톤, 5-asa, 퀴니딘, 모르핀, 펜타조신, 파라세타몰, 오메프라졸, 메토클로프라미드, 및 이들의 혼합물.
- 제 1 항 또는 제 6 항에 있어서, 정제, 분말 또는 젤라틴 캡슐임을 특징으로 하는 약학 형태.
- 제 1 항 또는 제 6 항에 있어서, 하나의 동일한 젤라틴 캡슐, 정제 또는 분말 내에 방출 키네틱이 상이한 미세캡슐 2 가지 이상의 타입을 혼합한 젤라틴 캡슐, 정제 또는 분말임을 특징으로 하는 약학 형태.
- 정제, 분말 또는 젤라틴 캡슐인 구강 미세입자 약학 형태 제조를 위해, 제 1 항에 정의된 미세캡슐을 사용하는 방법.
- 제 1 항 또는 제 6 항에 있어서, 잠복기 없이 발생하는 pH 1.4에서 pH 6.8로의 변이에 따른 방출 상태는, AP(활성원)의 50% 방출 시간 (t1/2)이 하기 (시간)로 정의됨을 특징으로 하는 약학 형태;0.5 ≤ t1/2 ≤ 15.
- 제 1 항 또는 제 6 항에 있어서, AP(활성원)이, 200-600 마이크론의 직경을 가지는 중성 핵에 침착됨을 특징으로 하는 약학 형태.
- 제 1 항 또는 제 6 항에 있어서, 소수성 화합물 B 가 수소화 목화씨 오일, 수소화 대두 오일, 수소화 야자 오일 및 이들의 혼합물을 포함하는 군에서 선택되는 것을 특징으로 하는 약학 형태.
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Application Number | Priority Date | Filing Date | Title |
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FR01/12999 | 2001-10-09 | ||
FR0112999A FR2830447B1 (fr) | 2001-10-09 | 2001-10-09 | Forme galenique orale microparticulaire pour la liberation retardee et controlee de principes actifs pharmaceutiques |
PCT/FR2002/003443 WO2003030878A2 (fr) | 2001-10-09 | 2002-10-09 | Forme galenique orale microparticulaire |
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KR1020107010770A Division KR20100063825A (ko) | 2001-10-09 | 2002-10-09 | 약학 활성원의 지연 및 조절된 방출을 위한 생약 미세입자 구강 제제 |
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KR20040073433A KR20040073433A (ko) | 2004-08-19 |
KR101078636B1 true KR101078636B1 (ko) | 2011-11-01 |
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KR1020107010770A KR20100063825A (ko) | 2001-10-09 | 2002-10-09 | 약학 활성원의 지연 및 조절된 방출을 위한 생약 미세입자 구강 제제 |
KR1020047005213A KR101078636B1 (ko) | 2001-10-09 | 2002-10-09 | 약학 활성원의 지연 및 조절된 방출을 위한 생약 미세입자구강 제제 |
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KR1020107010770A KR20100063825A (ko) | 2001-10-09 | 2002-10-09 | 약학 활성원의 지연 및 조절된 방출을 위한 생약 미세입자 구강 제제 |
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US (1) | US20050037077A1 (ko) |
EP (1) | EP1434572B1 (ko) |
JP (1) | JP4718116B2 (ko) |
KR (2) | KR20100063825A (ko) |
CN (1) | CN100341493C (ko) |
AU (1) | AU2002362712A1 (ko) |
BR (1) | BRPI0213175B8 (ko) |
CA (1) | CA2463134C (ko) |
ES (1) | ES2661723T3 (ko) |
FR (1) | FR2830447B1 (ko) |
HK (1) | HK1072898A1 (ko) |
IL (2) | IL160795A0 (ko) |
MX (1) | MXPA04003367A (ko) |
WO (1) | WO2003030878A2 (ko) |
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US8101209B2 (en) * | 2001-10-09 | 2012-01-24 | Flamel Technologies | Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles |
KR20050005437A (ko) | 2002-04-09 | 2005-01-13 | 플라멜 테크놀로지스 | 아목시실린의 변형 방출을 위한 마이크로캡슐 수성 현탁액형태의 경구 제약학적 제제 |
MXPA04009968A (es) | 2002-04-09 | 2004-12-13 | Flamel Tech Sa | Formulacion farmaceutica oral bajo forma de suspension acuosa de microcapsulas que permiten la liberacion modificada de principio (s) activo (s). |
ES2665464T3 (es) * | 2003-03-28 | 2018-04-25 | Sigmoid Pharma Limited | Forma de dosificación oral sólida que contiene microcápsulas sin costuras |
EP1691789B1 (en) * | 2003-11-25 | 2017-12-20 | SmithKline Beecham (Cork) Limited | Carvedilol free base, salts, anhydrous forms or solvate thereof, corresponding pharmaceutical compositions, controlled release formulations, and treatment or delivery methods |
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FR2862536B1 (fr) * | 2003-11-21 | 2007-11-23 | Flamel Tech Sa | Formulations pharmaceutiques pour la liberation prolongee de principe(s) actif(s), ainsi que leurs applications notamment therapeutiques |
CA2581775A1 (en) * | 2004-09-27 | 2006-04-06 | Sigmoid Biotechnologies Limited | Dihydropyrimidine microcapsule - formulations |
FR2881652B1 (fr) * | 2005-02-08 | 2007-05-25 | Flamel Technologies Sa | Forme pharmaceutique orale microparticulaire anti-mesuage |
US20070166378A1 (en) * | 2005-06-09 | 2007-07-19 | Flamel Technologies, Inc. | Oral ribavirin pharmaceutical compositions |
-
2001
- 2001-10-09 FR FR0112999A patent/FR2830447B1/fr not_active Expired - Lifetime
-
2002
- 2002-10-09 AU AU2002362712A patent/AU2002362712A1/en not_active Abandoned
- 2002-10-09 JP JP2003533910A patent/JP4718116B2/ja not_active Expired - Lifetime
- 2002-10-09 EP EP02800645.0A patent/EP1434572B1/fr not_active Expired - Lifetime
- 2002-10-09 CN CNB028200667A patent/CN100341493C/zh not_active Expired - Lifetime
- 2002-10-09 KR KR1020107010770A patent/KR20100063825A/ko not_active Application Discontinuation
- 2002-10-09 CA CA2463134A patent/CA2463134C/fr not_active Expired - Lifetime
- 2002-10-09 ES ES02800645.0T patent/ES2661723T3/es not_active Expired - Lifetime
- 2002-10-09 MX MXPA04003367A patent/MXPA04003367A/es active IP Right Grant
- 2002-10-09 BR BRPI0213175A patent/BRPI0213175B8/pt not_active IP Right Cessation
- 2002-10-09 IL IL16079502A patent/IL160795A0/xx unknown
- 2002-10-09 US US10/492,129 patent/US20050037077A1/en not_active Abandoned
- 2002-10-09 KR KR1020047005213A patent/KR101078636B1/ko active IP Right Grant
- 2002-10-09 WO PCT/FR2002/003443 patent/WO2003030878A2/fr active Application Filing
-
2004
- 2004-03-09 IL IL160795A patent/IL160795A/en active IP Right Grant
- 2004-03-29 ZA ZA2004/02460A patent/ZA200402460B/en unknown
-
2005
- 2005-06-29 HK HK05105498A patent/HK1072898A1/xx not_active IP Right Cessation
Patent Citations (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0383967A1 (en) * | 1989-02-17 | 1990-08-29 | Dojin Iyaku-Kako Co., Ltd. | Long acting diclofenac sodium preparation |
Also Published As
Publication number | Publication date |
---|---|
CA2463134A1 (fr) | 2003-04-17 |
HK1072898A1 (en) | 2005-09-16 |
US20050037077A1 (en) | 2005-02-17 |
JP4718116B2 (ja) | 2011-07-06 |
IL160795A0 (en) | 2004-08-31 |
ES2661723T3 (es) | 2018-04-03 |
CN100341493C (zh) | 2007-10-10 |
AU2002362712A1 (en) | 2003-04-22 |
CA2463134C (fr) | 2012-01-03 |
BR0213175A (pt) | 2004-09-14 |
FR2830447A1 (fr) | 2003-04-11 |
ZA200402460B (en) | 2005-08-31 |
MXPA04003367A (es) | 2005-01-25 |
KR20040073433A (ko) | 2004-08-19 |
BRPI0213175B8 (pt) | 2021-05-25 |
JP2005506336A (ja) | 2005-03-03 |
WO2003030878A2 (fr) | 2003-04-17 |
CN1568181A (zh) | 2005-01-19 |
FR2830447B1 (fr) | 2004-04-16 |
BRPI0213175B1 (pt) | 2017-06-20 |
EP1434572B1 (fr) | 2017-12-13 |
IL160795A (en) | 2010-11-30 |
KR20100063825A (ko) | 2010-06-11 |
WO2003030878A3 (fr) | 2003-12-04 |
EP1434572A2 (fr) | 2004-07-07 |
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