CN1382051A - 可注射的丁丙诺啡微粒组合物及其用途 - Google Patents
可注射的丁丙诺啡微粒组合物及其用途 Download PDFInfo
- Publication number
- CN1382051A CN1382051A CN00814728A CN00814728A CN1382051A CN 1382051 A CN1382051 A CN 1382051A CN 00814728 A CN00814728 A CN 00814728A CN 00814728 A CN00814728 A CN 00814728A CN 1382051 A CN1382051 A CN 1382051A
- Authority
- CN
- China
- Prior art keywords
- microgranule
- buprenorphine
- weight
- microparticle compositions
- poly
- 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.)
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
-
- 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
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/32—Alcohol-abuse
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
Abstract
Description
批号 | 狗ID | 纳 曲 酮载 药量,目标重量% | 纳 曲 酮载 药量,实际重量% | 包胶囊效率,% | 温度℃ | 聚合物的内 在 粘力,dL/g | 平均粒径,μm |
92 | 2062-HM | 50 | 38.3 | 77 | 1.07 | 57.76 | |
2067-HM | |||||||
2073-IM | |||||||
142 | 2063-JM | 50 | 42.5 | 85 | 1.07 | 44.36 | |
2066-JM | |||||||
2070-KM | |||||||
118a | 2065-FM | 60 | 49.0 | 82 | 22 | 1.07 | 39.78 |
2072-FM | |||||||
2075-GM | |||||||
a连续相在室温(22℃)下并且是用3%乙酸乙酯饱和的水 |
a.重制74b.用分散的药物批量制备c.将连续相冷却到11℃并且不含乙酸乙酯d.连续相在室温(22℃)下并且是用3%乙酸乙酯饱和的水 | e.在30℃、在0.5dL/g的浓度下、在CHCl3中测量比浓对数粘度f.含有2%重量羧甲基纤维素钠和1%重量吐温的注射媒介物 |
批号 | 纳曲酮剂量,mg | 微球剂量 | 媒 介物,ml | 在血浆中的纳 曲 酮(ng/ml)(hrs) | |||||
1hr | 2hr | 4hr | 8hr | 24hr | 48hr | ||||
92 | 165 | 430.8 | 1.8 | 6.8 | 2.79 | 1.82 | 0.73 | 0.82 | 0.81 |
147 | 383.8 | 1.8 | 6.33 | 4.14 | 2.34 | 0.64 | 0.86 | ||
202.5 | 528.7 | 1.7 | 9.66 | 5.28 | 2.41 | 0.89 | 1.13 | 0.61 | |
142 | 135 | 317.6 | 1.8 | 6.22 | 4.14 | 2.27 | 0.67 | 1.24 | 1.23 |
165 | 388.2 | 1.8 | 5.19 | 3.5 | 2.33 | 0.68 | 0.72 | 1.04 | |
191.3 | 566.5 | 1.7 | 17.28 | 8.79 | 3.21 | 1.35 | 1.02 | 0.84 | |
118 | 165 | 336.7 | 1.8 | 15.56 | 7.39 | 1.25 | 1.81 | 1.8 | |
133.5 | 272.4 | 1.9 | 7.6 | 4.04 | 1.77 | 0.79 | 0.71 | 0.9 | |
225 | 459.2 | 1.8 | 13.02 | 6.62 | 3.2 | 1.02 | 1.41 | 1.28 |
a.重制74b.用分散的药物批量制备c.将连续相冷却到11℃并且不含乙酸乙酯d.连续相在室温(22℃)下并且是用3%乙酸乙酯饱和的水 | e.在30℃、在0.5dL/g的浓度下、在CHCl3中测量比浓对数粘度f.含有2%重量羧甲基纤维素钠和1%重量吐温的注射媒介物 |
批号 | 在血浆中的纳曲酮ng/ml | |||||||
3天 | 7天 | 11天 | 14天 | 18天 | 21天 | 29天 | 35天 | |
92 | 1.17 | 24.95 | 5.14 | 3.99 | 3.27 | 3.63 | 1.38 | 0.7 |
0.62 | 18.04 | 11.13 | 7.22 | 4.87 | 3.42 | 1.8 | 1.55 | |
1.29 | 40.1 | 17.71 | 7.74 | 4.43 | 4.2 | 1.26 | NA | |
142 | 1.55 | 30.35 | 7.7 | 2.79 | 1.74 | 1.31 | 0.99 | 0.86 |
1.03 | 23.3 | 5.82 | 2.38 | 2.1 | 2.15 | 1.46 | 0.87 | |
1.14 | 32.27 | 11.98 | 2.73 | 7.18 | 5.74 | 1.8 | NA | |
118e | 2.44 | 45.3 | 7.17 | 4.65 | 1.22 | 0.48 | BQL | |
1.02 | 28.4 | 1.98 | 0.71 | BQL | ||||
2.21 | 35.01 | 5.63 | 2.07 | 1.44 | 0.54 | BQL | ||
BQL=在定量水平以下 |
a.重制74b.用分散的药物批量制备c.将连续相冷却到11℃并且不含乙酸乙酯d.连续相在室温(22℃)下并且是用3%乙酸乙酯饱和的水 | e.在30℃、在0.5dL/g的浓度下、在CHCl3中测量比浓对数粘度f.含有2%重量羧甲基纤维素钠和1%重量吐温的注射媒介物 |
批号 | 聚(DL-交酯)IV.dL/ga | 药物含量%重量丁丙诺啡 | 平均粒径,μm |
J606-019-00 | 0.37 | 21.2 | 52.8 |
J606-023-00 | 0.37 | 43.1 | 57.2 |
J606-037-00 | 1.07 | 44.1 | 63.1 |
J606-103-00 | 1.07 | 60.9 | 64.9 |
时间 | 丁丙诺啡血浆浓度,ng/ml | ||
J606-019-00 | J606-023-00 | J606-037-00 | |
1小时 | 7.23 | 2.86 | 4.98 |
2小时 | 10.3 | 5.80 | 7.13 |
4小时 | 13.2 | 3.75 | 4.92 |
8小时 | 9.42 | 2.62 | 2.58 |
24小时 | 2.22 | 2.45 | 2.27 |
48小时 | 3.01 | 1.85 | 1.15 |
72小时 | 2.54 | 1.42 | 0.86 |
5天 | 1.26 | 1.22 | 0.6 |
6天 | 1.16 | 0.98 | 0.66 |
7天 | 1.03 | 0.94 | 0.6 |
8天 | 1.39 | 1.45 | 0.59 |
12天 | 1.05 | 2.71 | 3.37 |
15天 | 0.96 | 4.41 | 3.02 |
19天 | 1.00 | 3.25 | 3.21 |
22天 | 1.30 | 3.01 | 2.64 |
26天 | 0.81 | 3.33 | 2.62 |
30天 | BQLa | 2.33 | 3.40 |
32天 | 0.66 | 1.63 | 3.25 |
36天 | 0.68 | 1.75 | 4.04 |
39天 | 0.58 | 1.82 | 3.53 |
43天 | BQL | 1.30 | 3.34 |
46天 | BQL | 1.00 | 3.35 |
50天 | BQL | 1.36 | 3.66 |
53天 | BQL | 1.26 | 3.74 |
57天 | BQL | 1.12 | 4.18 |
60天 | BQL | 1.03 | 3.53 |
64天 | BQL | 0.98 | 4.32 |
Claims (10)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15111299P | 1999-08-27 | 1999-08-27 | |
US60/151,112 | 1999-08-27 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2005100927174A Division CN100387228C (zh) | 1999-08-27 | 2000-08-25 | 可注射的美沙酮、部分类鸦片激动剂或类鸦片拮抗剂微粒组合物及其用途 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1382051A true CN1382051A (zh) | 2002-11-27 |
CN1248689C CN1248689C (zh) | 2006-04-05 |
Family
ID=22537367
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2005100927174A Expired - Fee Related CN100387228C (zh) | 1999-08-27 | 2000-08-25 | 可注射的美沙酮、部分类鸦片激动剂或类鸦片拮抗剂微粒组合物及其用途 |
CNB008147280A Expired - Fee Related CN1248689C (zh) | 1999-08-27 | 2000-08-25 | 可注射的美沙酮、丁丙诺啡微粒组合物及其用途 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CNB2005100927174A Expired - Fee Related CN100387228C (zh) | 1999-08-27 | 2000-08-25 | 可注射的美沙酮、部分类鸦片激动剂或类鸦片拮抗剂微粒组合物及其用途 |
Country Status (24)
Country | Link |
---|---|
US (2) | US6495155B1 (zh) |
EP (1) | EP1212061B1 (zh) |
JP (1) | JP4913298B2 (zh) |
KR (1) | KR100730440B1 (zh) |
CN (2) | CN100387228C (zh) |
AT (1) | ATE280579T1 (zh) |
AU (1) | AU765496C (zh) |
BR (1) | BR0013650A (zh) |
CA (1) | CA2382577C (zh) |
CY (1) | CY1106043T1 (zh) |
CZ (1) | CZ2002728A3 (zh) |
DE (1) | DE60015370T2 (zh) |
EA (1) | EA009080B1 (zh) |
ES (1) | ES2230154T3 (zh) |
HK (1) | HK1046858B (zh) |
HU (1) | HUP0203613A3 (zh) |
IL (2) | IL148343A0 (zh) |
MX (1) | MXPA02002105A (zh) |
NO (2) | NO322650B1 (zh) |
NZ (1) | NZ517997A (zh) |
PL (1) | PL198334B1 (zh) |
PT (1) | PT1212061E (zh) |
RO (1) | RO121631B1 (zh) |
WO (1) | WO2001015699A1 (zh) |
Cited By (5)
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CN102836131A (zh) * | 2012-09-28 | 2012-12-26 | 山东大学 | 丁丙诺啡皮下注射用缓释微球制剂及其制备方法 |
CN102164588B (zh) * | 2008-09-24 | 2015-07-08 | 赢创罗姆有限公司 | 耐受乙醇影响的pH依赖性受控释放的药物组合物 |
CN104984343A (zh) * | 2008-09-24 | 2015-10-21 | 赢创罗姆有限公司 | 耐受乙醇影响的非阿片类药物的pH依赖性受控释放的药物组合物 |
CN105377301A (zh) * | 2013-03-15 | 2016-03-02 | 奥克伍德实验室有限责任公司 | 高药物载量的丁丙诺啡微球和生产其的方法 |
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Cited By (8)
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CN102164588B (zh) * | 2008-09-24 | 2015-07-08 | 赢创罗姆有限公司 | 耐受乙醇影响的pH依赖性受控释放的药物组合物 |
CN104984343A (zh) * | 2008-09-24 | 2015-10-21 | 赢创罗姆有限公司 | 耐受乙醇影响的非阿片类药物的pH依赖性受控释放的药物组合物 |
US9757343B2 (en) | 2008-09-24 | 2017-09-12 | Evonik Röhm Gmbh | PH-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol |
CN104984343B (zh) * | 2008-09-24 | 2019-04-02 | 赢创罗姆有限公司 | 耐受乙醇影响的非阿片类药物的pH依赖性受控释放的药物组合物 |
US10933024B2 (en) | 2008-09-24 | 2021-03-02 | Evonik Operations Gmbh | PH-dependent controlled release pharmaceutical composition for non-opioids with resistance against the influence of ethanol |
CN102836131A (zh) * | 2012-09-28 | 2012-12-26 | 山东大学 | 丁丙诺啡皮下注射用缓释微球制剂及其制备方法 |
CN105377301A (zh) * | 2013-03-15 | 2016-03-02 | 奥克伍德实验室有限责任公司 | 高药物载量的丁丙诺啡微球和生产其的方法 |
CN105377301B (zh) * | 2013-03-15 | 2020-06-05 | 奥克伍德实验室有限责任公司 | 高药物载量的丁丙诺啡微球和生产其的方法 |
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