CN108348474B - 胃内滞留型活性递送系统 - Google Patents
胃内滞留型活性递送系统 Download PDFInfo
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- CN108348474B CN108348474B CN201680065309.6A CN201680065309A CN108348474B CN 108348474 B CN108348474 B CN 108348474B CN 201680065309 A CN201680065309 A CN 201680065309A CN 108348474 B CN108348474 B CN 108348474B
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Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K31/05—Phenols
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
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- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Mycology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
Description
材料 | 供应商 |
氯化钠 | Merck KGaA(Darmstadt,德国) |
盐酸 | Merck KGaA(Darmstadt,德国) |
纯净水 | - |
化合物 | 量[g] | 干物质[g] |
HPMC(粘度:2-25cPs) | 57.3 | 57.3 |
纯净水 | 515.7 | XX |
参数 | 单位 | 范围 |
进气温度 | [℃] | 29-31 |
产物温度 | [℃] | 22-24 |
进气流速 | [m<sup>3</sup>/h] | 138-142 |
喷射速率 | [g/min] | 7.3–12.8 |
雾化压力 | [巴] | 2.0 |
包衣时间 | [min] | 54 |
参数 | 单位 | 实施例4 | 实施例5 | 实施例6 |
进气温度 | [℃] | 29-31 | 29-31 | 26-30 |
产物温度 | [℃] | 23–25 | 23–25 | 21–25 |
进气流速 | [m<sup>3</sup>/h] | 138-142 | 142-148 | 140–163 |
喷射速率 | [g/min] | 8.5–13.5 | 8.3–13.9 | 8.4–10.2 |
雾化压力 | [巴] | 2.0 | 2.0 | 2.0 |
包衣时间 | [min] | 79 | 79 | 84 |
参数 | 单位 | 范围 |
进气温度 | [℃] | 28-32 |
产物温度 | [℃] | 24–25 |
进气流速 | [m<sup>3</sup>/h] | 150-157 |
喷射速率 | [g/min] | 8–11 |
雾化压力 | [巴] | 2.0 |
包衣时间 | [min] | 113 |
实施例7 | |
时间[min] | 释放[%] |
0 | 0 |
30 | 8.3 |
45 | 8.9 |
60 | 9.5 |
75 | 14 |
90 | 26 |
105 | 35 |
120 | 43 |
150 | 55 |
180 | 62 |
240 | 72 |
参数 | 单位 | 实施例8 | 实施例9 | 实施例10 |
进气温度 | [℃] | 39–41 | 39-40 | 28-34 |
产物温度 | [℃] | 32–34 | 32–34 | 28–30 |
进气流速 | [m<sup>3</sup>/h] | 138–142 | 180–220 | 180–220 |
喷射速率 | [g/min] | 8–13 | 3–10 | 3–7 |
雾化压力 | [巴] | 2.0 | 2.0 | 2.0 |
包衣时间 | [min] | 90 | 180 | 300 |
时间 | 实施例3 | 实施例6 | 实施例7 | 实施例8 |
min | 释放[%] | 释放[%] | 释放[%] | 释放[%] |
0 | 0 | 0 | 0 | 0 |
30 | 6.6 | 8.9 | 8.2 | 6.2 |
45 | 7.4 | 52 | 29 | 6.6 |
60 | 8.7 | 97 | 78 | 6.9 |
75 | 10 | 100 | 99 | 7.6 |
90 | 20 | 101 | 101 | 8.9 |
105 | 31 | 101 | 102 | 12 |
120 | 41 | 102 | 102 | 15 |
150 | 71 | 102 | 102 | 28 |
180 | 78 | 102 | 103 | 39 |
240 | 86 | 102 | 103 | 45 |
漂浮时间>2h | 是 | 否 | 否 | 是 |
参数 | 单位 | 范围 |
进气温度 | [℃] | 30-32 |
产物温度 | [℃] | 24–25 |
进气流速 | [m<sup>3</sup>/h] | 118-122 |
喷射速率 | [g/min] | 7.5–11 |
雾化压力 | [巴] | 2.0 |
包衣时间 | [min] | 87 |
实施例11 | |
时间[min] | 释放[%] |
0 | 0.2 |
30 | 0.2 |
45 | 0.1 |
60 | 0.1 |
75 | 0.1 |
90 | 0.1 |
105 | 0.8 |
120 | 0.5 |
150 | 0.6 |
180 | 0.3 |
240 | 0.4 |
漂浮时间>2h | 是 |
Claims (16)
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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EP15193887.5 | 2015-11-10 | ||
EP15193887.5A EP3167879A1 (en) | 2015-11-10 | 2015-11-10 | Gastric retention active delivery systems |
PCT/EP2016/075872 WO2017080833A1 (en) | 2015-11-10 | 2016-10-27 | Gastric retention active delivery systems |
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Publication Number | Publication Date |
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CN108348474A CN108348474A (zh) | 2018-07-31 |
CN108348474B true CN108348474B (zh) | 2021-05-25 |
Family
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CN201680065309.6A Expired - Fee Related CN108348474B (zh) | 2015-11-10 | 2016-10-27 | 胃内滞留型活性递送系统 |
Country Status (10)
Country | Link |
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US (1) | US10682307B2 (zh) |
EP (2) | EP3167879A1 (zh) |
JP (1) | JP2018532746A (zh) |
KR (1) | KR102095885B1 (zh) |
CN (1) | CN108348474B (zh) |
AU (1) | AU2016351701A1 (zh) |
CA (1) | CA3004615C (zh) |
ES (1) | ES2855873T3 (zh) |
HK (1) | HK1254725A1 (zh) |
WO (1) | WO2017080833A1 (zh) |
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WO2019096833A1 (en) | 2017-11-17 | 2019-05-23 | Evonik Röhm Gmbh | Process for preparing a coated hard shell capsule |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101505736A (zh) * | 2006-08-25 | 2009-08-12 | 贝林格尔.英格海姆国际有限公司 | 控制释放系统及其制造方法 |
EP1732522B1 (en) * | 2004-03-25 | 2012-07-04 | Sun Pharma Advanced Research Company Limited | Gastric retention system |
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FR2752732B1 (fr) * | 1996-08-28 | 1998-11-20 | Pf Medicament | Forme galenique a liberation prolongee de milnacipran |
SE9702533D0 (sv) * | 1997-07-01 | 1997-07-01 | Astra Ab | New oral formulation |
GB2462611A (en) * | 2008-08-12 | 2010-02-17 | Cambridge Lab | Pharmaceutical composition comprising tetrabenazine |
KR20110042366A (ko) * | 2008-08-18 | 2011-04-26 | 팀 아카데미 오브 파마슈티컬 사이언스 | 위장체류 약물 전달 시스템, 제작 방법 및 그것들의 사용 |
CA2790164A1 (en) * | 2010-02-17 | 2011-08-25 | Sun Pharma Advanced Research Company Ltd. | Method of treating a disease condition susceptible to baclofen therapy |
EP2605759B1 (en) * | 2010-08-18 | 2018-11-21 | Evonik Röhm GmbH | Gastric resistant pharmaceutical or nutraceutical formulation comprising one or more salts of alginic acid |
RS54024B1 (en) * | 2012-10-12 | 2015-10-30 | Omya International Ag | GASTRORETENCY FORMULATION OF MEDICINES AND SYSTEMS FOR DELIVERY AND METHODS OF THEIR PREPARATION USING FUNCTIONALIZED CALCIUM CARBONATE |
JP2018184387A (ja) * | 2017-04-26 | 2018-11-22 | 大正製薬株式会社 | 固形組成物 |
-
2015
- 2015-11-10 EP EP15193887.5A patent/EP3167879A1/en not_active Withdrawn
-
2016
- 2016-10-27 US US15/774,395 patent/US10682307B2/en active Active
- 2016-10-27 KR KR1020187013120A patent/KR102095885B1/ko active IP Right Grant
- 2016-10-27 CN CN201680065309.6A patent/CN108348474B/zh not_active Expired - Fee Related
- 2016-10-27 ES ES16787457T patent/ES2855873T3/es active Active
- 2016-10-27 AU AU2016351701A patent/AU2016351701A1/en not_active Abandoned
- 2016-10-27 WO PCT/EP2016/075872 patent/WO2017080833A1/en active Application Filing
- 2016-10-27 EP EP16787457.7A patent/EP3373915B1/en active Active
- 2016-10-27 CA CA3004615A patent/CA3004615C/en not_active Expired - Fee Related
- 2016-10-27 JP JP2018521414A patent/JP2018532746A/ja active Pending
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2018
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Publication number | Priority date | Publication date | Assignee | Title |
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EP1732522B1 (en) * | 2004-03-25 | 2012-07-04 | Sun Pharma Advanced Research Company Limited | Gastric retention system |
CN101505736A (zh) * | 2006-08-25 | 2009-08-12 | 贝林格尔.英格海姆国际有限公司 | 控制释放系统及其制造方法 |
Also Published As
Publication number | Publication date |
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EP3167879A1 (en) | 2017-05-17 |
JP2018532746A (ja) | 2018-11-08 |
KR20180079334A (ko) | 2018-07-10 |
HK1254725A1 (zh) | 2019-07-26 |
US10682307B2 (en) | 2020-06-16 |
CN108348474A (zh) | 2018-07-31 |
EP3373915B1 (en) | 2020-12-02 |
CA3004615A1 (en) | 2017-05-18 |
ES2855873T3 (es) | 2021-09-24 |
KR102095885B1 (ko) | 2020-04-01 |
US20190282493A1 (en) | 2019-09-19 |
WO2017080833A1 (en) | 2017-05-18 |
CA3004615C (en) | 2020-03-24 |
EP3373915A1 (en) | 2018-09-19 |
AU2016351701A1 (en) | 2018-05-24 |
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