CA2616081C - Gastroretentive formulations and manufacturing process thereof - Google Patents
Gastroretentive formulations and manufacturing process thereof Download PDFInfo
- Publication number
- CA2616081C CA2616081C CA2616081A CA2616081A CA2616081C CA 2616081 C CA2616081 C CA 2616081C CA 2616081 A CA2616081 A CA 2616081A CA 2616081 A CA2616081 A CA 2616081A CA 2616081 C CA2616081 C CA 2616081C
- Authority
- CA
- Canada
- Prior art keywords
- formulation according
- group
- gastroretentive
- weak
- gastroretentive formulation
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0053—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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- 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
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
-
- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Obesity (AREA)
- Inorganic Chemistry (AREA)
- Heart & Thoracic Surgery (AREA)
- Communicable Diseases (AREA)
- Emergency Medicine (AREA)
- Endocrinology (AREA)
- Hematology (AREA)
- Oncology (AREA)
- Cardiology (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Cosmetics (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05291542.8 | 2005-07-19 | ||
| EP05291542A EP1745775B1 (en) | 2005-07-19 | 2005-07-19 | Gastroretentive formulations and manufacturing process thereof. |
| PCT/IB2006/002636 WO2007010400A2 (en) | 2005-07-19 | 2006-07-19 | Gastroretentive formulations and manufacturing process thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2616081A1 CA2616081A1 (en) | 2007-01-25 |
| CA2616081C true CA2616081C (en) | 2013-09-10 |
Family
ID=35517256
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2616081A Active CA2616081C (en) | 2005-07-19 | 2006-07-19 | Gastroretentive formulations and manufacturing process thereof |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US9629800B2 (enExample) |
| EP (2) | EP1745775B1 (enExample) |
| JP (1) | JP5199084B2 (enExample) |
| KR (1) | KR101367814B1 (enExample) |
| CN (1) | CN101237858B (enExample) |
| AT (1) | ATE396710T1 (enExample) |
| AU (1) | AU2006271314B2 (enExample) |
| BR (1) | BRPI0612901B8 (enExample) |
| CA (1) | CA2616081C (enExample) |
| DE (1) | DE602005007205D1 (enExample) |
| RU (1) | RU2376983C2 (enExample) |
| WO (1) | WO2007010400A2 (enExample) |
Families Citing this family (23)
| Publication number | Priority date | Publication date | Assignee | Title |
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| KR20080076382A (ko) * | 2007-02-15 | 2008-08-20 | (주)아모레퍼시픽 | 실로스타졸의 제어방출 제제 및 그 제조방법 |
| CA2738114A1 (en) | 2008-09-22 | 2010-04-08 | Rubicon Research Private Limited | Compositions exhibiting delayed transit through the gastrointestinal tract |
| FR2945947B1 (fr) | 2009-05-29 | 2011-07-29 | Flamel Tech Sa | Compositions pharmaceutiques flottantes a liberation controlee |
| EP2457561A4 (en) | 2009-07-06 | 2014-03-05 | Kyorin Seiyaku Kk | TABLET WITH HIGH STRUCTURE |
| EP2361615A1 (en) | 2010-02-19 | 2011-08-31 | Alfred E. Tiefenbacher GmbH & Co. KG | Dipyridamole prolonged-release tablet |
| EP2544666A2 (en) | 2010-03-09 | 2013-01-16 | Council of Scientific and Industrial Research | Gastroretentive, extended release composition of therapeutic agent |
| CN104258408B (zh) * | 2010-03-31 | 2017-10-03 | 持田制药株式会社 | 易服用性固体制剂 |
| CN101919817B (zh) * | 2010-07-23 | 2012-05-30 | 山东齐都药业有限公司 | 一种拉呋替丁胃内滞留控制释放组合物 |
| CA2847614C (en) | 2011-09-30 | 2018-10-23 | Mochida Pharmaceutical Co., Ltd. | Easily dosable solid preparation |
| DE102012102414A1 (de) | 2012-03-21 | 2013-10-10 | Michael Dittgen | Pharmazeutische Zusammensetzung für die einmal tägliche Anwendung antidiabetischer Arzneimittel wie Metformin mit Zwei-Puls-Freisetzung |
| WO2013168179A2 (en) * | 2012-04-03 | 2013-11-14 | Rubicon Research Private Limited | Controlled release pharmaceutical formulations of antiviral agents |
| CN103110601B (zh) * | 2013-02-04 | 2014-10-29 | 成都恒瑞制药有限公司 | 一种格列齐特胃漂浮片及其制备方法 |
| FR3014692B1 (fr) * | 2013-12-18 | 2016-01-29 | Ethypharm Sa | Compositions pharmaceutiques orales a retention gastrique. |
| TWI705814B (zh) * | 2014-06-20 | 2020-10-01 | 美商梅琳塔有限責任公司 | 醫藥組成物及其用途 |
| KR102414503B1 (ko) | 2016-03-17 | 2022-06-29 | 티오제네시스 테라퓨틱스, 인크. | 시스테아민의 조절 방출을 위한 조성물 및 시스테아민 민감성 장애의 전신 치료 |
| CN107184560B (zh) * | 2017-06-03 | 2021-02-02 | 寿光富康制药有限公司 | 二甲双胍胃滞留片及制备方法 |
| US11612576B2 (en) | 2017-09-20 | 2023-03-28 | Thiogenesis Therapeutics, Inc. | Methods for the treatment of cysteamine sensitive disorders |
| IL275312B2 (en) | 2017-12-18 | 2024-09-01 | Tris Pharma Inc | Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system |
| US11337919B2 (en) * | 2017-12-18 | 2022-05-24 | Tris Pharma, Inc. | Modified release drug powder composition comprising gastro-retentive RAFT forming systems having trigger pulse drug release |
| US11337920B2 (en) | 2017-12-18 | 2022-05-24 | Tris Pharma, Inc. | Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release |
| CN109602714B (zh) * | 2018-12-29 | 2020-06-12 | 广东中润药物研发有限公司 | 一种利伐沙班胃滞留片及其制备方法 |
| GB2599950A (en) * | 2020-10-16 | 2022-04-20 | Zentiva Ks | Pharmaceutical compositions with low amounts of nitrosamine impurities and methods for producing the same |
| CN117042629A (zh) * | 2021-01-13 | 2023-11-10 | 杜邦营养美国公司 | 胃滞留药物递送系统 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61148115A (ja) * | 1984-12-21 | 1986-07-05 | Tooa Eiyoo Kk | 難溶性薬物の徐放性製剤及びその製造法 |
| GB8618847D0 (en) * | 1986-08-01 | 1986-09-10 | Smith Kline French Lab | Pharmaceutical formulations |
| FR2653337B1 (fr) * | 1989-10-23 | 1992-02-07 | Dow Corning Sa | Element a liberation prolongee et procede pour le fabriquer. |
| US6635280B2 (en) | 1997-06-06 | 2003-10-21 | Depomed, Inc. | Extending the duration of drug release within the stomach during the fed mode |
| ES2234139T3 (es) * | 1997-08-11 | 2005-06-16 | Alza Corporation | Forma de dosificacion de un agente activo de liberacion prolongada adaptada para la retencion gastrica. |
| IN186245B (enExample) | 1997-09-19 | 2001-07-14 | Ranbaxy Lab Ltd | |
| CA2320900C (en) * | 1998-03-19 | 2009-10-27 | Bristol-Myers Squibb Company | Biphasic controlled release delivery system for high solubility pharmaceuticals and method |
| ID29843A (id) * | 1998-09-14 | 2001-10-18 | Ranbaxy Lab Ltd | Sistem pemberian obat melalui mulut yang dikontrol secara teratur yang memberikan pengontrolan tempat dan bersifat sementara |
| US6797283B1 (en) | 1998-12-23 | 2004-09-28 | Alza Corporation | Gastric retention dosage form having multiple layers |
| DE69927708T2 (de) * | 1998-12-23 | 2006-07-06 | Alza Corp., Mountain View | Dosierungsformen, die poröse partikel enthalten |
| US6635281B2 (en) * | 1998-12-23 | 2003-10-21 | Alza Corporation | Gastric retaining oral liquid dosage form |
| EA200200914A1 (ru) * | 2000-03-03 | 2003-02-27 | Рэнбакси Лабораториз Лимитед | Система контроля дозирования для однократного ежедневного приема назначенного ципрофлоксацина |
| KR20040018394A (ko) * | 2001-07-04 | 2004-03-03 | 썬 파마슈티컬 인더스트리스 리미티드 | 위 정체 제어되는 약물 전달 계 |
| EP1509208A1 (en) * | 2002-02-04 | 2005-03-02 | Ranbaxy Laboratories Limited | Hydrodynamically balancing oral drug delivery system with biphasic release |
| GB0205253D0 (en) * | 2002-03-06 | 2002-04-17 | Univ Gent | Immediate release pharmaceutical granule compositions and a continuous process for making them |
| WO2003101431A1 (en) | 2002-06-04 | 2003-12-11 | J.B. Chemicals & Pharmaceuticals Ltd. | Pharmaceutical composition for controlled drug delivery system |
| WO2005060942A1 (en) * | 2003-12-19 | 2005-07-07 | Aurobindo Pharma Ltd | Extended release pharmaceutical composition of metformin |
-
2005
- 2005-07-19 DE DE602005007205T patent/DE602005007205D1/de not_active Expired - Lifetime
- 2005-07-19 EP EP05291542A patent/EP1745775B1/en not_active Expired - Lifetime
- 2005-07-19 AT AT05291542T patent/ATE396710T1/de not_active IP Right Cessation
-
2006
- 2006-07-19 EP EP06795542A patent/EP1904034A2/en not_active Withdrawn
- 2006-07-19 CN CN2006800265896A patent/CN101237858B/zh active Active
- 2006-07-19 US US11/996,023 patent/US9629800B2/en active Active
- 2006-07-19 CA CA2616081A patent/CA2616081C/en active Active
- 2006-07-19 JP JP2008522096A patent/JP5199084B2/ja not_active Expired - Fee Related
- 2006-07-19 BR BRPI0612901A patent/BRPI0612901B8/pt active IP Right Grant
- 2006-07-19 RU RU2008106220/15A patent/RU2376983C2/ru active
- 2006-07-19 KR KR1020087003902A patent/KR101367814B1/ko not_active Expired - Fee Related
- 2006-07-19 WO PCT/IB2006/002636 patent/WO2007010400A2/en not_active Ceased
- 2006-07-19 AU AU2006271314A patent/AU2006271314B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| US20080220060A1 (en) | 2008-09-11 |
| WO2007010400A2 (en) | 2007-01-25 |
| RU2376983C2 (ru) | 2009-12-27 |
| KR20080048461A (ko) | 2008-06-02 |
| JP2009501777A (ja) | 2009-01-22 |
| AU2006271314B2 (en) | 2011-07-07 |
| CA2616081A1 (en) | 2007-01-25 |
| AU2006271314A1 (en) | 2007-01-25 |
| CN101237858A (zh) | 2008-08-06 |
| US9629800B2 (en) | 2017-04-25 |
| EP1904034A2 (en) | 2008-04-02 |
| BRPI0612901A2 (pt) | 2010-12-07 |
| BRPI0612901B8 (pt) | 2021-05-25 |
| CN101237858B (zh) | 2012-07-04 |
| DE602005007205D1 (de) | 2008-07-10 |
| EP1745775B1 (en) | 2008-05-28 |
| BRPI0612901B1 (pt) | 2020-08-04 |
| RU2008106220A (ru) | 2009-08-27 |
| HK1122729A1 (en) | 2009-05-29 |
| EP1745775A1 (en) | 2007-01-24 |
| KR101367814B1 (ko) | 2014-02-27 |
| WO2007010400A3 (en) | 2007-04-05 |
| JP5199084B2 (ja) | 2013-05-15 |
| ATE396710T1 (de) | 2008-06-15 |
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