CN1335768A - 多颗粒改进释放组合物 - Google Patents
多颗粒改进释放组合物 Download PDFInfo
- Publication number
- CN1335768A CN1335768A CN99814002A CN99814002A CN1335768A CN 1335768 A CN1335768 A CN 1335768A CN 99814002 A CN99814002 A CN 99814002A CN 99814002 A CN99814002 A CN 99814002A CN 1335768 A CN1335768 A CN 1335768A
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- active component
- composition
- modified release
- multiparticulate modified
- release composition
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4458—Non condensed piperidines, e.g. piperocaine only substituted in position 2, e.g. methylphenidate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
Description
表1:即时释放成分溶液 | |
组分盐酸哌醋甲酯聚乙二醇6000聚乙烯吡咯烷酮纯水 | 量%(w/w) |
(i) (ii)13.0 13.00.5 0.53.583.5 86.5 |
表2:改进释放成分包衣溶液 | |
组分EudragitRS12.5EudragitS12.5EudragitL12.5聚乙烯吡咯烷酮邻苯二甲酸二乙酯柠檬酸三乙酯异丙醇丙酮滑石1 | 量%(w/w) |
(i) (ii) (iii) (iv) (v) (vi) (vii) (viii)49.7 42.0 47.1 53.2 40.6 - - 25.0- - - - 54.35 46.5 -- - - - - - - 25.0- - - 0.35 0.3 - - -0.5 0.5 0.6 1.35 0.6 1.3 1.1 -- - - - - - - 1.2539.8 33.1 37.2 45.1 33.8 44.35 49.6 46.510.0 8.3 9.3 - 8.4 - - -- 16.0 5.9 - 16.3 - 2.8 2.25 |
表3(a):用表2中给出的包衣溶液配制的改进释放成分的溶解数据 | |
包表层配方 | (i) (i) (i) (ii) (ii) (ii) (iii) (iii) |
包衣层含量(%所得重量) | 4% 6% 10% 4% 6% 8% 4% 6% |
时间(小时) | 活性组分释放的% |
1246810 | 0 0 0 8.5 1.3 1.4 6.1 3.017.0 3.3 0 36.9 7.1 3.7 21.3 8.251.5 22.1 0 80.0 40.3 15.1 62.3 26.375.8 46.5 0 92.8 72.4 31.2 82.1 52.686.0 65.5 10.2 97.5 83.0 47.5 91.3 73.091.3 76.5 17.3 - - - 97.7 86.5 |
表3(b):用表2中给出的包衣溶液配制的改进释放成分的溶解数据 | |
包衣层配方 | (iv) (iv) (iv) (v) (v) |
包衣层含量(%重量增加) | 10% 15% 20% 10% 12.5% |
时间(小时) | 活性组分释放的% |
1246810 | 3.5 0.9 1.1 1.3 1.013.4 5.4 2.9 6.1 2.947.1 22.5 13.8 42.4 21.280.0 52.0 36.9 77.5 54.494.8 70.3 61.0 92.4 79.7103 81.5 76.1 - - |
表3(c):用表2中给出的包衣溶液配制的改进释放成分的溶解数据 | |
包衣层配方 | (vi) (vi) (vi) (vi)* (vii) (vii) (viii) (viii) |
包衣层含量(%所得重量) | 5% 10% 15% 15% 15% 20% 20% 30% |
时间(小时) | 活性组分释放的% |
1246810 | 33.2 0.4 0 0 3.9 0.6 3.8 2.180.6 9.8 0 0.5 52.0 12.4 7.4 3.192.2 43.5 10.1 44.0 85.0 61.6 43.7 8.993.9 61.6 29.9 80.2 89.9 75.3 72.4 39.694.3 67.5 48.4 69.0 91.4 79.6 79.2 63.994.4 - 60.0 - - - 79.5 73.4 |
表4.含有IR成分和改进释放成分的组合物的溶解数据 | |
MR包衣制剂 | (vii) (viii) |
包衣层含量(重量增加%) | 30% 30% |
0 | 0 0 |
0.5 | 49.7 50.2 |
1 | 49.7 50.5 |
2 | 49.8 51.1 |
4 | 56.1 54.1 |
6 | 65.2 68.0 |
8 | 72.2 81.8 |
10 | 76.6 87.0 |
IR成分 %(w/w)盐酸哌醋甲酯 10微晶纤维素 40乳糖 45聚维酮 5 | MR成分 %(w/w)盐酸哌醋甲酯 10微晶纤维素 40EudragitRS 45聚维酮 5 |
表5(b):用50mg进释放(MR)成分给50mgIR成分包囊而得到20mg剂量浓度的产品 | |
IR成分 %(w/w)盐酸哌醋甲酯 20微晶纤维素 50乳糖 28聚维酮 2 | MR成分 %(w/w)盐酸哌醋甲酯 20微晶纤维素 50EudragitS 28聚维酮 5 |
Claims (36)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10672698P | 1998-11-02 | 1998-11-02 | |
US60/106,726 | 1998-11-02 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN02132215A Division CN1403076A (zh) | 1998-11-02 | 2002-08-30 | 多颗粒改进释放组合物 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1335768A true CN1335768A (zh) | 2002-02-13 |
CN100444830C CN100444830C (zh) | 2008-12-24 |
Family
ID=22312931
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB998140023A Expired - Lifetime CN100444830C (zh) | 1998-11-02 | 1999-11-01 | 多颗粒改进释放组合物 |
CN02132215A Pending CN1403076A (zh) | 1998-11-02 | 2002-08-30 | 多颗粒改进释放组合物 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN02132215A Pending CN1403076A (zh) | 1998-11-02 | 2002-08-30 | 多颗粒改进释放组合物 |
Country Status (31)
Country | Link |
---|---|
US (7) | US6228398B1 (zh) |
EP (3) | EP1126826B3 (zh) |
JP (2) | JP4613275B2 (zh) |
KR (3) | KR20080032661A (zh) |
CN (2) | CN100444830C (zh) |
AR (1) | AR021858A1 (zh) |
AT (1) | ATE411011T3 (zh) |
AU (4) | AU770645B2 (zh) |
BR (1) | BRPI9914977B8 (zh) |
CA (2) | CA2653839A1 (zh) |
CO (1) | CO5261536A1 (zh) |
CY (1) | CY1110421T1 (zh) |
CZ (1) | CZ303495B6 (zh) |
DE (1) | DE69939748D1 (zh) |
DK (1) | DK1126826T6 (zh) |
ES (1) | ES2313797T7 (zh) |
HK (1) | HK1050487A1 (zh) |
HU (1) | HU230454B1 (zh) |
ID (1) | ID29852A (zh) |
IL (4) | IL142896A0 (zh) |
MX (1) | MXPA01004381A (zh) |
MY (1) | MY122159A (zh) |
NO (1) | NO343240B1 (zh) |
NZ (1) | NZ511442A (zh) |
PE (1) | PE20001322A1 (zh) |
PL (1) | PL205109B1 (zh) |
PT (1) | PT1126826E (zh) |
RU (1) | RU2236847C2 (zh) |
SK (1) | SK287674B6 (zh) |
TR (1) | TR200101216T2 (zh) |
WO (1) | WO2000025752A1 (zh) |
Cited By (5)
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CN101111230B (zh) * | 2005-03-29 | 2010-05-19 | 赢创罗姆有限责任公司 | 包含对活性成分具有调节释放作用的小丸的多颗粒药用形式 |
CN101933913A (zh) * | 2010-09-16 | 2011-01-05 | 孙卫东 | 一种盐酸右哌甲酯双释放制剂及其制备方法 |
CN102429884A (zh) * | 2011-12-29 | 2012-05-02 | 天津市嵩锐医药科技有限公司 | 盐酸哌甲酯口腔崩解药物组合物 |
CN105025883A (zh) * | 2013-03-29 | 2015-11-04 | 沃克哈特有限公司 | 右哌甲酯或其盐的调节释放的药物组合物 |
CN106794147A (zh) * | 2014-07-28 | 2017-05-31 | Sk化学株式会社 | 包含亮丙瑞林并同时具有立即释放和持续释放特性的药物组合物 |
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101111230B (zh) * | 2005-03-29 | 2010-05-19 | 赢创罗姆有限责任公司 | 包含对活性成分具有调节释放作用的小丸的多颗粒药用形式 |
CN101933913A (zh) * | 2010-09-16 | 2011-01-05 | 孙卫东 | 一种盐酸右哌甲酯双释放制剂及其制备方法 |
CN102429884A (zh) * | 2011-12-29 | 2012-05-02 | 天津市嵩锐医药科技有限公司 | 盐酸哌甲酯口腔崩解药物组合物 |
CN105025883A (zh) * | 2013-03-29 | 2015-11-04 | 沃克哈特有限公司 | 右哌甲酯或其盐的调节释放的药物组合物 |
CN106794147A (zh) * | 2014-07-28 | 2017-05-31 | Sk化学株式会社 | 包含亮丙瑞林并同时具有立即释放和持续释放特性的药物组合物 |
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