JPH07505126A - 放出持続性ジルチアゼム製剤 - Google Patents
放出持続性ジルチアゼム製剤Info
- Publication number
- JPH07505126A JPH07505126A JP5509045A JP50904593A JPH07505126A JP H07505126 A JPH07505126 A JP H07505126A JP 5509045 A JP5509045 A JP 5509045A JP 50904593 A JP50904593 A JP 50904593A JP H07505126 A JPH07505126 A JP H07505126A
- Authority
- JP
- Japan
- Prior art keywords
- pharmaceutically acceptable
- diltiazem
- layer
- membrane layer
- polymeric material
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K9/5078—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 with drug-free core
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (7)
- 1.経口投与のための放出持続性ジルチアゼム製剤において、刺激的作用を有す ることのある有機酸の無い微顆粒を備え、該微顆粒は、(a)中心の不活性な球 状粒子、 (b)該球状粒子の周囲を複数の交互になった第1と第2の層で囲んでコアが形 成され、該第1の層は、水溶性、製薬上許容される重合体材料を備え、かつ該第 2の層はジルチアゼムまたは製薬上許容されるそれらの塩類を備え、および、( c)該コアに設けられた第1の内部膜層、該第1の内部膜層は第1の製薬上許容 される不溶性の重合体を備え、および該第1の内部膜層の周囲に相対的に厚くか つ均質な層として形成さ札、かつ該第1の製薬上許容される不溶性の重合体と異 なる第2の製薬上許容される不溶性の重合体材料を備える単一の外部膜とを備え た外部被覆、とを備え、 該第1の内部膜層の数と該単一の外部膜の厚さは、該微顆粒からのジルチアゼム の放出が経口投与後24時間の期間を超えてそれの吸収が制御されるような速度 で起こるように選択されており、その速度は米国薬局方XXIIに相当する次の 溶解パターン、 (a)全ジルチアゼムの15から40%が測定の4時間後に放出され、(b)全 ジルチアゼムの40から70%が測定の8時間後に放出され、(c)全ジルチア ゼムの50から85%が測定の12時間後に放出され、および(d)全ジルチア ゼムの70から100%が測定の24時間後に放出され、に従ったタイプ2の溶 解装置において測定される時の微顆粒の溶解速度としてインビトロて測定される ものである、上記の製剤。
- 2.経口投与のための放出持続性ジルチアゼム製剤において、刺激的作用を有す ることのある有機酸の無い微顆粒を備え、該ペレットは、(a)中心の不活性な 球体、 (b)該球体の周囲を複数の交互になった第1と第2の層で囲んでコアが形成さ れ、該第1の層は、水溶性、製薬上許容される重合体材料を備え、かつ該第2の 層はジルチアゼムまたは製薬上許容されるそれらの塩類を備え、および、(c) 該コアに設けられた第1の内部膜層、該第1の内部膜層は第1の製薬上許容され る不溶性の重合体を備え、および該第1の内部膜層の周囲に相村的に厚くかつ均 質な層として形成され、かつ該第1の製薬上許容される不溶性の重合体と別の第 2の製薬上許容される不溶性の重合体材料を備える単一の外部膜とを備えた外部 被覆、とを備え、 該第1の内部膜層の数と該単一の外部膜の厚さは、該微顆粒からのジルチアゼム の放出が経口投与後12から24時間の期間を越えてそれの吸収が製御されるよ うな速度で起こる、上記の製剤。
- 3.該水溶性、製薬上許容される重合体材料が、ポリビニルビロリドン、ポリエ チレングリコール、ポリビニルアルコールおよびそれらの混合物より成る群から 選択されることを特徴とする請求の範囲第1項又は第2項記載の製剤。
- 4.該第1の製薬上許容される不溶性の重合体材料がエチルセルロースであり、 かつ第2の製薬上許容される不溶性の重合体材料が、アクリル及びメタクリル酸 エステルのコポリマー、酢酸セルロースフタレート、および登録商標EUDRA GITL、EUDRAGITRSおよびAQUACOATとして流通しているそ れらのもの、より成る群から選択されるものであることを特徴とする請求の範囲 第1項又は第2項記載の製剤。
- 5.該第1の膜層中と該単一の外部膜中に滑剤を含み、該滑剤はタルク、ステア リン酸カルシウム、ステアリン酸亜鉛、ステアリン酸マグネシウムより成る群か ら選択されたものであることを特徴とする請求の範囲第1項又は第2項記載の製 剤。
- 6.該単一の外部膜中に可塑剤を含むことを特徴とする請求の範囲第1項又は第 2項記載の製剤。
- 7.該可塑剤か、フタル酸ジエチル、ポリエチレングリコール、フタル酸ジブチ ルおよびトリアセチンより成る群から選択されたものであることを特徴とする請 求の範囲第6項記載の製剤。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/797,496 US5229135A (en) | 1991-11-22 | 1991-11-22 | Sustained release diltiazem formulation |
US797,496 | 1991-11-22 | ||
PCT/FR1992/001083 WO1993009767A1 (fr) | 1991-11-22 | 1992-11-23 | Formulation a base de diltiazem a liberation prolongee |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH07505126A true JPH07505126A (ja) | 1995-06-08 |
JP3009467B2 JP3009467B2 (ja) | 2000-02-14 |
Family
ID=25170994
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP5509045A Expired - Lifetime JP3009467B2 (ja) | 1991-11-22 | 1992-11-23 | 放出持続性ジルチアゼム製剤 |
Country Status (7)
Country | Link |
---|---|
US (1) | US5229135A (ja) |
EP (1) | EP0613370B1 (ja) |
JP (1) | JP3009467B2 (ja) |
CA (1) | CA2124012C (ja) |
DE (1) | DE69203242T2 (ja) |
ES (1) | ES2074387T3 (ja) |
WO (1) | WO1993009767A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000506500A (ja) * | 1995-12-22 | 2000-05-30 | ラボラトワール、デ、プロデュイ、エティック、エティファルム | 活性成分としてジルチアゼムを含有してなる徐放性微粒子 |
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Family Cites Families (6)
Publication number | Priority date | Publication date | Assignee | Title |
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IE55745B1 (en) * | 1983-04-06 | 1991-01-02 | Elan Corp Plc | Sustained absorption pharmaceutical composition |
PH18946A (en) * | 1983-04-21 | 1985-11-14 | Elan Corp Plc | Controlled absorption pharmaceutical composition |
IE56999B1 (en) * | 1983-12-22 | 1992-03-11 | Elan Corp Plc | Pharmaceutical formulation |
US4894240A (en) * | 1983-12-22 | 1990-01-16 | Elan Corporation Plc | Controlled absorption diltiazem formulation for once-daily administration |
US5002776A (en) * | 1983-12-22 | 1991-03-26 | Elan Corporation, Plc | Controlled absorption diltiazem formulations |
FR2623714B1 (fr) * | 1987-11-26 | 1990-04-20 | Ethypharm Sa | Forme a liberation prolongee du diltiazem, et son medicament ainsi obtenu |
-
1991
- 1991-11-22 US US07/797,496 patent/US5229135A/en not_active Expired - Fee Related
-
1992
- 1992-11-23 JP JP5509045A patent/JP3009467B2/ja not_active Expired - Lifetime
- 1992-11-23 DE DE69203242T patent/DE69203242T2/de not_active Expired - Lifetime
- 1992-11-23 WO PCT/FR1992/001083 patent/WO1993009767A1/fr active IP Right Grant
- 1992-11-23 EP EP93901758A patent/EP0613370B1/fr not_active Expired - Lifetime
- 1992-11-23 CA CA002124012A patent/CA2124012C/fr not_active Expired - Lifetime
- 1992-11-23 ES ES93901758T patent/ES2074387T3/es not_active Expired - Lifetime
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2000506500A (ja) * | 1995-12-22 | 2000-05-30 | ラボラトワール、デ、プロデュイ、エティック、エティファルム | 活性成分としてジルチアゼムを含有してなる徐放性微粒子 |
Also Published As
Publication number | Publication date |
---|---|
WO1993009767A1 (fr) | 1993-05-27 |
ES2074387T3 (es) | 1995-09-01 |
EP0613370B1 (fr) | 1995-06-28 |
CA2124012A1 (fr) | 1993-05-27 |
JP3009467B2 (ja) | 2000-02-14 |
CA2124012C (fr) | 2000-02-01 |
US5229135A (en) | 1993-07-20 |
DE69203242D1 (de) | 1995-08-03 |
EP0613370A1 (fr) | 1994-09-07 |
DE69203242T2 (de) | 1996-03-14 |
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