BRPI0612901B8 - formulações gastrorretentivas e processo para preparação das mesmas - Google Patents

formulações gastrorretentivas e processo para preparação das mesmas

Info

Publication number
BRPI0612901B8
BRPI0612901B8 BRPI0612901A BRPI0612901A BRPI0612901B8 BR PI0612901 B8 BRPI0612901 B8 BR PI0612901B8 BR PI0612901 A BRPI0612901 A BR PI0612901A BR PI0612901 A BRPI0612901 A BR PI0612901A BR PI0612901 B8 BRPI0612901 B8 BR PI0612901B8
Authority
BR
Brazil
Prior art keywords
preparation
formulations
gastroretentive formulations
gastroretentive
gelling agent
Prior art date
Application number
BRPI0612901A
Other languages
English (en)
Portuguese (pt)
Inventor
Chaudhari Mahenda
D Chandwani Omprakash
S Yelegaonkar Rajashree
Original Assignee
Ethypharm Sa
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 Sa filed Critical Ethypharm Sa
Publication of BRPI0612901A2 publication Critical patent/BRPI0612901A2/pt
Publication of BRPI0612901B1 publication Critical patent/BRPI0612901B1/pt
Publication of BRPI0612901B8 publication Critical patent/BRPI0612901B8/pt

Links

Classifications

    • 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
    • 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
    • A61K9/20Pills, 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)
BRPI0612901A 2005-07-19 2006-07-19 formulações gastrorretentivas e processo para preparação das mesmas BRPI0612901B8 (pt)

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 (3)

Publication Number Publication Date
BRPI0612901A2 BRPI0612901A2 (pt) 2010-12-07
BRPI0612901B1 BRPI0612901B1 (pt) 2020-08-04
BRPI0612901B8 true BRPI0612901B8 (pt) 2021-05-25

Family

ID=35517256

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0612901A BRPI0612901B8 (pt) 2005-07-19 2006-07-19 formulações gastrorretentivas e processo para preparação das mesmas

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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* Cited by examiner, † Cited by third party
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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

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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
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
HUP0204417A3 (en) * 2000-03-03 2005-03-29 Ranbaxy Lab Ltd Oral ciprofloxacin-composition of controlled release
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

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
AU2006271314B2 (en) 2011-07-07
AU2006271314A1 (en) 2007-01-25
EP1745775B1 (en) 2008-05-28
BRPI0612901B1 (pt) 2020-08-04
ATE396710T1 (de) 2008-06-15
EP1904034A2 (en) 2008-04-02
US9629800B2 (en) 2017-04-25
KR101367814B1 (ko) 2014-02-27
KR20080048461A (ko) 2008-06-02

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Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 04/08/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/07/2006 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF