WO2007010400A2 - Gastroretentive formulations and manufacturing process thereof - Google Patents

Gastroretentive formulations and manufacturing process thereof Download PDF

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Publication number
WO2007010400A2
WO2007010400A2 PCT/IB2006/002636 IB2006002636W WO2007010400A2 WO 2007010400 A2 WO2007010400 A2 WO 2007010400A2 IB 2006002636 W IB2006002636 W IB 2006002636W WO 2007010400 A2 WO2007010400 A2 WO 2007010400A2
Authority
WO
WIPO (PCT)
Prior art keywords
formulation according
optionally
group
anyone
mixtures
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.)
Ceased
Application number
PCT/IB2006/002636
Other languages
English (en)
French (fr)
Other versions
WO2007010400A3 (en
Inventor
Mahendra Chaudhari
Omprakash D. Chandwani
Rajashree S. Yelegaonkar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethypharm SAS
Original Assignee
Ethypharm SAS
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ethypharm SAS filed Critical Ethypharm SAS
Priority to JP2008522096A priority Critical patent/JP5199084B2/ja
Priority to EP06795542A priority patent/EP1904034A2/en
Priority to CN2006800265896A priority patent/CN101237858B/zh
Priority to KR1020087003902A priority patent/KR101367814B1/ko
Priority to CA2616081A priority patent/CA2616081C/en
Priority to BRPI0612901A priority patent/BRPI0612901B8/pt
Priority to AU2006271314A priority patent/AU2006271314B2/en
Priority to US11/996,023 priority patent/US9629800B2/en
Priority to HK08113911.1A priority patent/HK1122729B/xx
Publication of WO2007010400A2 publication Critical patent/WO2007010400A2/en
Publication of WO2007010400A3 publication Critical patent/WO2007010400A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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

Definitions

  • the invention relates to gastroretentive formulations, in particular tablets, and to the process for manufacturing said formulations .
  • the ratio of the weak gelling agent to the strong gelling agent ranges between 1:1 to 1:10, preferably from 1:2 to 1:8 and even more preferably between 1:3 to 1:5.
  • the ratio of the substance active to both weak and strong gelling agents ranges from 1:99 to 99:1, preferably from 1:1 to 20 : 1, and even more preferably from 2:1 to 15 :1
  • the gas generating agent is a compound which generates gas when it is in contact with an acidic medium, such as gastric fluid.
  • Said gas generating agent is selected from the group consisting in water soluble carbonates, sulfites and bicarbonates, such as sodium carbonate, sodium bicarbonate, sodium metabisulfite, calcium carbonate, and mixtures thereof.
  • the amount of gas generating agent ranges from 5 to 30%, preferably from 10 to 25 % and even more preferably from 12 to 22% by weight of the total weight of the formulation.
  • a binder selected from the group consisting in low
  • the gas generating agent is dry mixed with granules obtained from step ( 2) optionally with excipients selected from the group comprising diluents, lubricating agents, wetting agents, sweetners, flavours, colorants and mixtures thereof,
  • Metformin Hydrochloride 2 % Extra quantity taken ) , Avicel CL 611, xanthan gum were mixed together in a suitable mixer such as high shear mixer or planetory mixer.
  • the blend was granulated with a solution of PVP K 30 in isopropyl alcohol and water. The wet mass was dried in a drier till a moisture content between 3.5 to 5.5 % was obtained.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Cosmetics (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
PCT/IB2006/002636 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof Ceased WO2007010400A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
JP2008522096A JP5199084B2 (ja) 2005-07-19 2006-07-19 胃保持型製剤およびそれらの製造方法
EP06795542A EP1904034A2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
CN2006800265896A CN101237858B (zh) 2005-07-19 2006-07-19 胃滞留制剂及其制备方法
KR1020087003902A KR101367814B1 (ko) 2005-07-19 2006-07-19 위장체류 제제 및 이의 제조 방법
CA2616081A CA2616081C (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
BRPI0612901A BRPI0612901B8 (pt) 2005-07-19 2006-07-19 formulações gastrorretentivas e processo para preparação das mesmas
AU2006271314A AU2006271314B2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
US11/996,023 US9629800B2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof
HK08113911.1A HK1122729B (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof

Applications Claiming Priority (2)

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.

Publications (2)

Publication Number Publication Date
WO2007010400A2 true WO2007010400A2 (en) 2007-01-25
WO2007010400A3 WO2007010400A3 (en) 2007-04-05

Family

ID=35517256

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2006/002636 Ceased WO2007010400A2 (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)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010519201A (ja) * 2007-02-15 2010-06-03 アモーレパシフィック コーポレイション シロスタゾールを含む制御放出製剤及びその製造方法
WO2010136739A2 (fr) 2009-05-29 2010-12-02 Flamel Technologies Compositions pharmaceutiques flottantes à libération contrôlée
US9603805B2 (en) 2011-09-30 2017-03-28 Mochida Pharmaceutical Co., Ltd. Easily dosable solid preparation
US11666546B2 (en) 2017-12-18 2023-06-06 Tris Pharma, Inc GHB pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
US12201720B2 (en) 2017-12-18 2025-01-21 Tris Pharma Inc Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release

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* Cited by examiner, † Cited by third party
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WO2010038237A2 (en) 2008-09-22 2010-04-08 Rubicon Research Private Limited Compositions exhibiting delayed transit through the gastrointestinal tract
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
WO2011111068A2 (en) 2010-03-09 2011-09-15 Council Of Scientific And Industrial Research Gastroretentive, extended release composition of therapeutic agent
CA2788732C (en) * 2010-03-31 2017-08-15 Yumio Kudou Easily dosable solid preparation
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
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
CN109310653A (zh) 2016-03-17 2019-02-05 硫创治疗公司 用于控制释放半胱胺和系统治疗半胱胺敏感性病症的组合物
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
ES3024932T3 (en) 2017-09-20 2025-06-05 Thiogenesis Therapeutics Inc Compounds for the treatment of cysteamine sensitive disorders
AU2018388577B2 (en) * 2017-12-18 2024-06-06 Tris Pharma, Inc. Modified release drug powder composition comprising 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
WO2022152741A1 (en) * 2021-01-13 2022-07-21 DuPont Nutrition USA, Inc. A gastroretentive drug delivery system

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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
WO1999007342A1 (en) * 1997-08-11 1999-02-18 Alza Corporation Prolonged release active agent dosage form adapted for gastric retention
IN186245B (enExample) 1997-09-19 2001-07-14 Ranbaxy Lab Ltd
CN1203846C (zh) 1998-03-19 2005-06-01 布里斯托尔-迈尔斯斯奎布公司 高溶解性药物的双相控释递送系统和方法
NZ523747A (en) * 1998-09-14 2004-04-30 Ranbaxy Lab Ltd Pharmaceutical composition comprising a drug, a gas generating component, a swelling agent, a viscolyzing agent and a gel forning polymer
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AP2001002084A0 (en) * 2000-03-03 2001-03-31 Ranbaxy Lab Ltd Orally administered controlled delivery system for once daily adminstration of ciprofloxacin
WO2003097018A1 (en) * 2002-02-04 2003-11-27 Ranbaxy Laboratories Limited Hydrodynamically balancing oral drug delivery system with biphasic release
MXPA03012041A (es) * 2001-07-04 2004-03-26 Sun Pharmaceutical Ind Ltd Sistema de administracion controlada de farmacos de retencion gastrica.
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

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010519201A (ja) * 2007-02-15 2010-06-03 アモーレパシフィック コーポレイション シロスタゾールを含む制御放出製剤及びその製造方法
WO2010136739A2 (fr) 2009-05-29 2010-12-02 Flamel Technologies Compositions pharmaceutiques flottantes à libération contrôlée
US9561179B2 (en) 2009-05-29 2017-02-07 Flamel Ireland Limited Controlled-release floating pharmaceutical compositions
US10092511B2 (en) 2009-05-29 2018-10-09 Flamel Ireland Limited Controlled-release floating pharmaceutical compositions
US9603805B2 (en) 2011-09-30 2017-03-28 Mochida Pharmaceutical Co., Ltd. Easily dosable solid preparation
US9789068B2 (en) 2011-09-30 2017-10-17 Mochida Pharmaceutical Co., Ltd. Easily dosable solid preparation
US11666546B2 (en) 2017-12-18 2023-06-06 Tris Pharma, Inc GHB pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
US12201720B2 (en) 2017-12-18 2025-01-21 Tris Pharma Inc Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release

Also Published As

Publication number Publication date
RU2008106220A (ru) 2009-08-27
KR20080048461A (ko) 2008-06-02
CN101237858A (zh) 2008-08-06
BRPI0612901A2 (pt) 2010-12-07
DE602005007205D1 (de) 2008-07-10
HK1122729A1 (en) 2009-05-29
JP2009501777A (ja) 2009-01-22
AU2006271314B2 (en) 2011-07-07
EP1745775A1 (en) 2007-01-24
AU2006271314A1 (en) 2007-01-25
BRPI0612901B8 (pt) 2021-05-25
CA2616081A1 (en) 2007-01-25
EP1904034A2 (en) 2008-04-02
US20080220060A1 (en) 2008-09-11
RU2376983C2 (ru) 2009-12-27
KR101367814B1 (ko) 2014-02-27
US9629800B2 (en) 2017-04-25
CA2616081C (en) 2013-09-10
CN101237858B (zh) 2012-07-04
BRPI0612901B1 (pt) 2020-08-04
EP1745775B1 (en) 2008-05-28
JP5199084B2 (ja) 2013-05-15
WO2007010400A3 (en) 2007-04-05
ATE396710T1 (de) 2008-06-15

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