AU2006271314B2 - Gastroretentive formulations and manufacturing process thereof - Google Patents

Gastroretentive formulations and manufacturing process thereof Download PDF

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Publication number
AU2006271314B2
AU2006271314B2 AU2006271314A AU2006271314A AU2006271314B2 AU 2006271314 B2 AU2006271314 B2 AU 2006271314B2 AU 2006271314 A AU2006271314 A AU 2006271314A AU 2006271314 A AU2006271314 A AU 2006271314A AU 2006271314 B2 AU2006271314 B2 AU 2006271314B2
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AU
Australia
Prior art keywords
formulation according
optionally
group
anyone
mixtures
Prior art date
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AU2006271314A
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English (en)
Other versions
AU2006271314A1 (en
Inventor
Omprakash D. Chandwani
Mahendra Chaudhari
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
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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
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Application filed by Ethypharm SAS filed Critical Ethypharm SAS
Publication of AU2006271314A1 publication Critical patent/AU2006271314A1/en
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Publication of AU2006271314B2 publication Critical patent/AU2006271314B2/en
Active legal-status Critical Current
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0065Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Obesity (AREA)
  • Oncology (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Cosmetics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU2006271314A 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof Active AU2006271314B2 (en)

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
AU2006271314A1 AU2006271314A1 (en) 2007-01-25
AU2006271314B2 true AU2006271314B2 (en) 2011-07-07

Family

ID=35517256

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2006271314A Active AU2006271314B2 (en) 2005-07-19 2006-07-19 Gastroretentive formulations and manufacturing process thereof

Country Status (12)

Country Link
US (1) US9629800B2 (https=)
EP (2) EP1745775B1 (https=)
JP (1) JP5199084B2 (https=)
KR (1) KR101367814B1 (https=)
CN (1) CN101237858B (https=)
AT (1) ATE396710T1 (https=)
AU (1) AU2006271314B2 (https=)
BR (1) BRPI0612901B8 (https=)
CA (1) CA2616081C (https=)
DE (1) DE602005007205D1 (https=)
RU (1) RU2376983C2 (https=)
WO (1) WO2007010400A2 (https=)

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KR20080076382A (ko) * 2007-02-15 2008-08-20 (주)아모레퍼시픽 실로스타졸의 제어방출 제제 및 그 제조방법
WO2010038237A2 (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
CA2767143A1 (en) 2009-07-06 2011-01-13 Kyorin Pharmaceutical Co., Ltd. Tablet having hollow 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
KR101767288B1 (ko) * 2010-03-31 2017-08-10 모찌다 세이야쿠 가부시끼가이샤 복용 용이성 고형 제제
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
WO2013046453A1 (ja) 2011-09-30 2013-04-04 持田製薬株式会社 易服用性固形製剤
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
JP7418958B2 (ja) 2016-03-17 2024-01-22 チオジェネシス セラピューティクス, インコーポレイテッド システアミンの制御放出のための組成物及びシステアミン感受性障害の全身治療
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
JP7208982B2 (ja) 2017-09-20 2023-01-19 チオジェネシス セラピューティクス, インコーポレイテッド システアミン感受性障害の治療方法
WO2019126216A1 (en) 2017-12-18 2019-06-27 Tris Phama, Inc. Pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
EP3737353A1 (en) 2017-12-18 2020-11-18 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
WO2019126214A1 (en) 2017-12-18 2019-06-27 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
JP2024502378A (ja) * 2021-01-13 2024-01-18 デュポン・ニュートリション・ユーエスエイ,インコーポレイテッド 胃内滞留型薬物送達系

Citations (1)

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US20030232081A1 (en) * 2002-06-04 2003-12-18 J. B. Chemicals & Pharmaceuticals Pharmaceutical composition for controlled 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
PT1003476E (pt) * 1997-08-11 2005-05-31 Alza Corp Forma de dosagem de agente activo de libertacao prolongada adaptada para retencao gastrica
IN186245B (https=) 1997-09-19 2001-07-14 Ranbaxy Lab Ltd
EP1063973B1 (en) 1998-03-19 2016-11-16 Bristol-Myers Squibb Company Biphasic controlled release delivery system for high solubility pharmaceuticals and method
ATE245414T1 (de) * 1998-09-14 2003-08-15 Ranbaxy Lab Ltd Oral verabreichtes system zur zeitlich und räumlich gesteuerten arzneistoffabgabe
US6797283B1 (en) 1998-12-23 2004-09-28 Alza Corporation Gastric retention dosage form having multiple layers
EP1140027B1 (en) * 1998-12-23 2005-10-12 Alza Corporation Dosage forms comprising porous particles
US6635281B2 (en) * 1998-12-23 2003-10-21 Alza Corporation Gastric retaining oral liquid dosage form
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Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US20030232081A1 (en) * 2002-06-04 2003-12-18 J. B. Chemicals & Pharmaceuticals Pharmaceutical composition for controlled drug delivery system

Also Published As

Publication number Publication date
CA2616081A1 (en) 2007-01-25
EP1745775A1 (en) 2007-01-24
JP2009501777A (ja) 2009-01-22
HK1122729A1 (en) 2009-05-29
CN101237858B (zh) 2012-07-04
US20080220060A1 (en) 2008-09-11
JP5199084B2 (ja) 2013-05-15
WO2007010400A3 (en) 2007-04-05
CA2616081C (en) 2013-09-10
DE602005007205D1 (de) 2008-07-10
WO2007010400A2 (en) 2007-01-25
RU2008106220A (ru) 2009-08-27
CN101237858A (zh) 2008-08-06
BRPI0612901A2 (pt) 2010-12-07
RU2376983C2 (ru) 2009-12-27
AU2006271314A1 (en) 2007-01-25
EP1745775B1 (en) 2008-05-28
BRPI0612901B1 (pt) 2020-08-04
ATE396710T1 (de) 2008-06-15
BRPI0612901B8 (pt) 2021-05-25
EP1904034A2 (en) 2008-04-02
US9629800B2 (en) 2017-04-25
KR101367814B1 (ko) 2014-02-27
KR20080048461A (ko) 2008-06-02

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