KR910018016A - 피복 조성물 및 그의 제조방법 - Google Patents
피복 조성물 및 그의 제조방법 Download PDFInfo
- Publication number
- KR910018016A KR910018016A KR1019910005907A KR910005907A KR910018016A KR 910018016 A KR910018016 A KR 910018016A KR 1019910005907 A KR1019910005907 A KR 1019910005907A KR 910005907 A KR910005907 A KR 910005907A KR 910018016 A KR910018016 A KR 910018016A
- Authority
- KR
- South Korea
- Prior art keywords
- hot melt
- melt material
- coating composition
- coating
- active substance
- Prior art date
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Classifications
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Nanotechnology (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Crystallography & Structural Chemistry (AREA)
- Biophysics (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Glanulating (AREA)
- Polyurethanes Or Polyureas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
내용 없음
Description
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 후술되는 실시예 3에서 수득된 피복 과립, 및 용해 매질로 제1시험액 및 정제수를 사용하여 측정한 용해곡선을 나타낸다. 제2도는 후술되는 실시예 4에서 수득된 피복 과립, 및 용해 매질로 제1시험액 및 정제수를 사용하여 측정한 용해 곡선을 나타낸다.
Claims (16)
- 결합체인 제1열용융 물질의 도움으로 서로 응집하는 열-안정성 약 학상 활성 물질 미립자를 함유하는 과립을 함유하며, 이들 과립의 각각이 제1열용융 물질의 융점보다 저융점을 갖는 제2열용융 물질로 피복되고, 이들 과립이 용매 부재하에 원심력 과립화 방법에 의해 제조됨을 특징으로 하는, 열-안정성 약학상 활성 물질을 함유하는 피복 조성물.
- 제1항에 있어서, 경구 투여성인 피복 조성물,
- 제1항에 있어서, 과립제인 피복 조성물.
- 제1항에 있어서, 활성 물질이 4-구아니디노메틸 시클로헥산카르복실산2′-벤질옥시카르보닐페닐 에스테르 히드로클로덱스트린의 시클로덱스트린 내포 화합물인 피복 조성물.
- 열-안정성 약학상 활성 물질 및 결합제로 제1열용융 물질을 함유하는 혼합물을 가열하에 용매 부재하에 원심 과립화하고, 생성 과립을 제1열용융 물질의 융점보다 저융점을 갖는 제2열용융 물질을 피복 물질로 사용하여 가열하에 피복 시킴을 특징으로 하는, 열-안정성 약학상 활성 물질을 함유하는 피복 조성물의 제조방법.
- 제5항에 있어서, 과립화가 제1열용융 물질이용융 상태로 유지되는 조건하에 혼합물을 회전시킴으로써 수행되는 방법.
- 제5항에 있어서, 피복이 제2열용융 물질이 용융 상태로 유지되는 조건하에 제2열용융 물질을 가하면서 과립을 회전시킴으로써 수행되는 방법.
- 제5항에 있어서, 제2열용융 물질이 혼합물을 기준으로 약 5∼30중량%의 친수성 물질 및 약 10∼60중량%의 소수성 물질을 함유하는 혼합물인 방법.
- 제5항에 있어서, 제1열용융 물질이 폴리에틸렌 글리콜을 함유하는 방법.
- 제9항에 있어서, 폴리에틸렌 글리콜이 평균 분자량 약1,000 이상을 갖는 방법.
- 제5항에 있어서, 제1열용융 물질이 소량의-d-토코페롤을 부가적으로 함유하는 방법.
- 제5항에 있어서, 제1열용융 물질이 친수성이며 물에 용이하게 용해될 수 있는 방법.
- 제5항에 있어서, 피복물이 2층으로 형성되는 방법.
- 제13항에 있어서, 2층이 친수성 물질을 갖는 내부층 및 소수성 물질을 갖는 외부층을 함유하는 방법.
- 제5항에 있어서, 피복 조성물이 경구 투여성인 방법.
- 제5항에 있어서, 피복 조성물이 과립제인 방법.※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP9666390 | 1990-04-12 | ||
JP96663/1990 | 1990-04-12 | ||
JP096663/1990 | 1990-04-12 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR910018016A true KR910018016A (ko) | 1991-11-30 |
KR0168849B1 KR0168849B1 (ko) | 1999-01-15 |
Family
ID=14171060
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1019910005907A KR0168849B1 (ko) | 1990-04-12 | 1991-04-12 | 피목 조성물 및 그의 제조방법 |
Country Status (8)
Country | Link |
---|---|
EP (1) | EP0452145B1 (ko) |
JP (1) | JP3191948B2 (ko) |
KR (1) | KR0168849B1 (ko) |
AT (1) | ATE145131T1 (ko) |
DE (1) | DE69123075T2 (ko) |
DK (1) | DK0452145T3 (ko) |
ES (1) | ES2096624T3 (ko) |
GR (1) | GR3021606T3 (ko) |
Families Citing this family (29)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE4217920C2 (de) * | 1992-05-30 | 1996-05-09 | Goldwell Gmbh | Verfahren zur Herstellung von pulverförmigen Mitteln zum Blondieren von menschlichen Haaren |
US5429825A (en) * | 1992-06-26 | 1995-07-04 | Mcneil-Ppc, Inc. | Rotomelt granulation |
IL109460A (en) | 1993-05-10 | 1998-03-10 | Euro Celtique Sa | Controlled release formulation comprising tramadol |
GB9310030D0 (en) * | 1993-05-15 | 1993-06-30 | Scras | Dry processed particles and process for the preparation of the same |
FR2705677B1 (fr) * | 1993-05-28 | 1995-08-11 | Roquette Freres | Micro-granules obtenus par extrusion-sphéronisation contenant une cyclodextrine. |
IL110014A (en) | 1993-07-01 | 1999-11-30 | Euro Celtique Sa | Solid controlled-release oral dosage forms of opioid analgesics |
US7740881B1 (en) | 1993-07-01 | 2010-06-22 | Purdue Pharma Lp | Method of treating humans with opioid formulations having extended controlled release |
US5879705A (en) * | 1993-07-27 | 1999-03-09 | Euro-Celtique S.A. | Sustained release compositions of morphine and a method of preparing pharmaceutical compositions |
US5891471A (en) | 1993-11-23 | 1999-04-06 | Euro-Celtique, S.A. | Pharmaceutical multiparticulates |
KR100354702B1 (ko) | 1993-11-23 | 2002-12-28 | 유로-셀티크 소시에떼 아노뉨 | 약학조성물의제조방법및서방형조성물 |
US5843480A (en) | 1994-03-14 | 1998-12-01 | Euro-Celtique, S.A. | Controlled release diamorphine formulation |
GB9422154D0 (en) | 1994-11-03 | 1994-12-21 | Euro Celtique Sa | Pharmaceutical compositions and method of producing the same |
US5965161A (en) | 1994-11-04 | 1999-10-12 | Euro-Celtique, S.A. | Extruded multi-particulates |
JP3466921B2 (ja) * | 1998-06-03 | 2003-11-17 | 大塚製薬株式会社 | 味マスキング医薬製剤 |
US6806294B2 (en) | 1998-10-15 | 2004-10-19 | Euro-Celtique S.A. | Opioid analgesic |
AU1323400A (en) * | 1998-10-27 | 2000-05-15 | Fuisz Technologies Ltd. | Microparticles containing peg and/or peg glyceryl esters |
AT407111B (de) | 1998-12-22 | 2000-12-27 | Gergely Dr & Co | Zucker- und/oder zuckeralkoholhältiges matrixmaterial und verfahren zu seiner herstellung |
DE19918325A1 (de) | 1999-04-22 | 2000-10-26 | Euro Celtique Sa | Verfahren zur Herstellung von Arzneiformen mit regulierter Wirkstofffreisetzung mittels Extrusion |
MXPA02004293A (es) | 1999-10-29 | 2002-10-31 | Euro Celtique Sa | Formulaciones de hidrocodona de liberacion controlada.. |
US10179130B2 (en) | 1999-10-29 | 2019-01-15 | Purdue Pharma L.P. | Controlled release hydrocodone formulations |
JP4658306B2 (ja) * | 2000-10-18 | 2011-03-23 | ナガセ医薬品株式会社 | 錠剤用医薬組成物 |
CN100518827C (zh) | 2000-10-30 | 2009-07-29 | 欧罗赛铁克股份有限公司 | 控释氢可酮制剂 |
US20110104214A1 (en) | 2004-04-15 | 2011-05-05 | Purdue Pharma L.P. | Once-a-day oxycodone formulations |
UA81224C2 (uk) | 2001-05-02 | 2007-12-25 | Euro Celtic S A | Дозована форма оксикодону та її застосування |
JP2005506323A (ja) * | 2001-09-05 | 2005-03-03 | ベクトゥラ・リミテッド | 経口送達用機能性散剤 |
JP2005298412A (ja) * | 2004-04-13 | 2005-10-27 | Minato Pharmaceutical Co Ltd | 被覆粒子 |
KR20100015845A (ko) * | 2007-04-26 | 2010-02-12 | 에자이 알앤드디 매니지먼트 가부시키가이샤 | 정제의 제조 방법 |
CN115209877A (zh) * | 2020-03-11 | 2022-10-18 | 泽井制药株式会社 | 颗粒和使用该颗粒的制剂 |
WO2023145865A1 (ja) * | 2022-01-31 | 2023-08-03 | 住友精化株式会社 | 製剤用ポリアルキレンオキシド粒子、医薬用組成物、製剤用組成物及び製剤 |
Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5838250A (ja) * | 1981-09-01 | 1983-03-05 | Teikoku Chem Ind Corp Ltd | 複合体 |
US4797288A (en) * | 1984-10-05 | 1989-01-10 | Warner-Lambert Company | Novel drug delivery system |
US4940665A (en) * | 1985-12-27 | 1990-07-10 | Showa Denko K. K. | Method for granulation of enzyme |
US5019302A (en) * | 1986-03-12 | 1991-05-28 | Washington University Technology Associates, Inc. | Method for granulation |
DE3721721C1 (de) * | 1987-07-01 | 1988-06-09 | Hoechst Ag | Verfahren zur Umhuellung von Granulaten |
NZ231281A (en) * | 1988-11-08 | 1991-01-29 | Takeda Chemical Industries Ltd | Sustained release pharmaceutical preparations comprising the active agent dispersed in a solid matrix of a fatty acid ester of a polyglycerol |
-
1991
- 1991-04-12 DE DE69123075T patent/DE69123075T2/de not_active Expired - Fee Related
- 1991-04-12 DK DK91303256.1T patent/DK0452145T3/da active
- 1991-04-12 ES ES91303256T patent/ES2096624T3/es not_active Expired - Lifetime
- 1991-04-12 AT AT91303256T patent/ATE145131T1/de not_active IP Right Cessation
- 1991-04-12 EP EP91303256A patent/EP0452145B1/en not_active Expired - Lifetime
- 1991-04-12 KR KR1019910005907A patent/KR0168849B1/ko not_active IP Right Cessation
- 1991-04-12 JP JP07984391A patent/JP3191948B2/ja not_active Expired - Fee Related
-
1996
- 1996-11-14 GR GR960402815T patent/GR3021606T3/el unknown
Also Published As
Publication number | Publication date |
---|---|
EP0452145B1 (en) | 1996-11-13 |
GR3021606T3 (en) | 1997-02-28 |
ATE145131T1 (de) | 1996-11-15 |
DK0452145T3 (da) | 1996-12-02 |
DE69123075D1 (de) | 1996-12-19 |
KR0168849B1 (ko) | 1999-01-15 |
ES2096624T3 (es) | 1997-03-16 |
JPH04217913A (ja) | 1992-08-07 |
DE69123075T2 (de) | 1997-03-20 |
EP0452145A2 (en) | 1991-10-16 |
EP0452145A3 (en) | 1993-03-10 |
JP3191948B2 (ja) | 2001-07-23 |
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