AU2005276583B2 - Fast release composition including melt granules of a moisture sensitive drug and process for manufacturing thereof - Google Patents

Fast release composition including melt granules of a moisture sensitive drug and process for manufacturing thereof Download PDF

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Publication number
AU2005276583B2
AU2005276583B2 AU2005276583A AU2005276583A AU2005276583B2 AU 2005276583 B2 AU2005276583 B2 AU 2005276583B2 AU 2005276583 A AU2005276583 A AU 2005276583A AU 2005276583 A AU2005276583 A AU 2005276583A AU 2005276583 B2 AU2005276583 B2 AU 2005276583B2
Authority
AU
Australia
Prior art keywords
pharmaceutical composition
moisture
dpp
sensitive
granules
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
AU2005276583A
Other languages
English (en)
Other versions
AU2005276583A1 (en
Inventor
Yatindra Joshi
Oskar Kalb
James Kowalski
Abu T. M. Serajuddin
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.)
Novartis AG
Original Assignee
Novartis AG
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=35447883&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2005276583(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis AG filed Critical Novartis AG
Publication of AU2005276583A1 publication Critical patent/AU2005276583A1/en
Application granted granted Critical
Publication of AU2005276583B2 publication Critical patent/AU2005276583B2/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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Organic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2005276583A 2004-08-27 2005-08-26 Fast release composition including melt granules of a moisture sensitive drug and process for manufacturing thereof Ceased AU2005276583B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US60532704P 2004-08-27 2004-08-27
US60/605,327 2004-08-27
US61682804P 2004-10-07 2004-10-07
US60/616,828 2004-10-07
PCT/EP2005/009252 WO2006021455A1 (en) 2004-08-27 2005-08-26 Fast release composition including melt granules of a moisture sensitive drug and process for manufacturing thereof

Publications (2)

Publication Number Publication Date
AU2005276583A1 AU2005276583A1 (en) 2006-03-02
AU2005276583B2 true AU2005276583B2 (en) 2009-12-03

Family

ID=35447883

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2005276583A Ceased AU2005276583B2 (en) 2004-08-27 2005-08-26 Fast release composition including melt granules of a moisture sensitive drug and process for manufacturing thereof

Country Status (21)

Country Link
US (1) US20080050443A1 (https=)
EP (2) EP1786401B1 (https=)
JP (1) JP5147399B2 (https=)
KR (8) KR20160136465A (https=)
CN (1) CN101010068B (https=)
AR (1) AR050615A1 (https=)
AU (1) AU2005276583B2 (https=)
BR (1) BRPI0514682B8 (https=)
CA (1) CA2575499A1 (https=)
DK (1) DK1786401T3 (https=)
ES (1) ES2647671T3 (https=)
HU (1) HUE034653T2 (https=)
MX (1) MX2007002253A (https=)
MY (1) MY144297A (https=)
PE (1) PE20060652A1 (https=)
PL (1) PL1786401T3 (https=)
PT (1) PT1786401T (https=)
RU (1) RU2383332C2 (https=)
SI (1) SI1786401T1 (https=)
TW (1) TWI402082B (https=)
WO (1) WO2006021455A1 (https=)

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DK1715893T3 (da) 2004-01-20 2009-11-09 Novartis Pharma Ag Direkte kompressionsformulering og fremgangsmåde
PL1712547T3 (pl) 2004-02-05 2012-04-30 Kyorin Seiyaku Kk Pochodna bicykloestrowa
AR050615A1 (es) 2004-08-27 2006-11-08 Novartis Ag Composiciones farmaceuticas para la administracion oral
EP1995237A4 (en) 2006-03-08 2011-07-06 Kyorin Seiyaku Kk PROCESS FOR PREPARING AN AMINOACETYLPYRROLIDINCARBONITRILE DERIVATIVE AND PRODUCTION PRODUCT THEREOF
WO2007128801A1 (en) * 2006-05-08 2007-11-15 Novartis Ag Combination of organic compounds
US8143427B2 (en) 2007-03-22 2012-03-27 Kyorin Pharmaceutical Co., Ltd. Method for producing aminoacetylpyrrolidinecarbonitrile derivative
DE102008020701A1 (de) * 2008-04-24 2009-10-29 Bayer Technology Services Gmbh Formulierung mit reduzierter Hygroskopizität
CA2732984A1 (en) 2008-08-07 2010-02-11 Kyorin Pharmaceutical Co., Ltd. Process for production of bicyclo[2.2.2]octylamine derivative
CN102186474A (zh) * 2008-08-14 2011-09-14 杏林制药株式会社 稳定的医药组合物
AR073651A1 (es) * 2008-09-24 2010-11-24 Novartis Ag Formulaciones galenicas de compuestos organicos
CN102438617A (zh) 2009-03-27 2012-05-02 杏林制药株式会社 含有碱性添加剂的基质型缓释制剂
JP2011057586A (ja) * 2009-09-08 2011-03-24 Kyorin Pharmaceutical Co Ltd ｐＨ非依存性マトリックス型徐放性製剤
TR201002256A1 (tr) * 2010-03-24 2011-10-21 Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� Stabil aliskiren formülasyonları
US9071358B2 (en) 2012-06-21 2015-06-30 Qualcomm Incrorporated Repeater fiber-coax units
US8989577B2 (en) 2012-06-21 2015-03-24 Qualcomm Incorporated Methods and systems for implementing time-division duplexing in the physical layer
US9363017B2 (en) 2012-07-06 2016-06-07 Qualcomm Incorporated Methods and systems of specifying coaxial resource allocation across a MAC/PHY interface
JP6283316B2 (ja) * 2012-10-26 2018-02-21 株式会社三和化学研究所 アナグリプチン含有固形製剤
WO2014152207A1 (en) * 2013-03-15 2014-09-25 Mylan Laboratories, Inc. Hot melt granulation formulations of poorly water-soluble active agents
CN104274408A (zh) * 2013-07-10 2015-01-14 北京科信必成医药科技发展有限公司 一种熔融包衣的速释药物微粒及其制备方法
US20150366813A1 (en) * 2014-06-20 2015-12-24 Banner Life Sciences Llc Liquid-filled immediate release soft gelatin capsules
WO2018050892A1 (en) 2016-09-16 2018-03-22 Galenicum Health S.L. Vildagliptin pharmaceutical compositions

Family Cites Families (20)

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Publication number Priority date Publication date Assignee Title
IL109770A0 (en) * 1993-05-29 1994-11-28 Smithkline Beecham Corp Thermal infusion process for preparing controlled release solid dosage forms of medicaments for oral administration and controlled release solid dosage forms of medicaments prepared thereby
WO1995005808A1 (en) * 1993-08-24 1995-03-02 Abbott Laboratories Oil-based tableting method
ATE212224T1 (de) * 1993-11-23 2002-02-15 Euro Celtique Sa Verfahren zur herstellung einer arzneizusammensetzung mit verzögerter wirkstoffabgabe
IL111785A0 (en) 1993-12-03 1995-01-24 Ferring Bv Dp-iv inhibitors and pharmaceutical compositions containing them
US20020142037A1 (en) 1996-10-01 2002-10-03 Nabil Farah Process for the manufacture of a pharmaceutical composition with modified release of active principle comprising a matrix
WO1998018763A1 (en) 1996-10-25 1998-05-07 Tanabe Seiyaku Co., Ltd. Tetrahydroisoquinoline derivatives
US6011155A (en) 1996-11-07 2000-01-04 Novartis Ag N-(substituted glycyl)-2-cyanopyrrolidines, pharmaceutical compositions containing them and their use in inhibiting dipeptidyl peptidase-IV
TW492957B (en) 1996-11-07 2002-07-01 Novartis Ag N-substituted 2-cyanopyrrolidnes
WO1999013864A2 (en) 1997-09-19 1999-03-25 Shire Laboratories, Inc. Solid solution beadlet
DE19823831A1 (de) 1998-05-28 1999-12-02 Probiodrug Ges Fuer Arzneim Neue pharmazeutische Verwendung von Isoleucyl Thiazolidid und seinen Salzen
CO5150173A1 (es) * 1998-12-10 2002-04-29 Novartis Ag Compuestos n-(glicilo sustituido)-2-cianopirrolidinas inhibidores de peptidasa de dipeptidilo-iv (dpp-iv) los cuales son efectivos en el tratamiento de condiciones mediadas por la inhibicion de dpp-iv
US6107317A (en) 1999-06-24 2000-08-22 Novartis Ag N-(substituted glycyl)-thiazolidines, pharmaceutical compositions containing them and their use in inhibiting dipeptidyl peptidase-IV
US20020015730A1 (en) * 2000-03-09 2002-02-07 Torsten Hoffmann Pharmaceutical formulations and method for making
CN1500080A (zh) 2001-02-02 2004-05-26 ����ҩƷ��ҵ��ʽ���� 稠合杂环化合物
UA74912C2 (en) 2001-07-06 2006-02-15 Merck & Co Inc Beta-aminotetrahydroimidazo-(1,2-a)-pyrazines and tetratriazolo-(4,3-a)-pyrazines as inhibitors of dipeptylpeptidase for the treatment or prevention of diabetes
US7985422B2 (en) * 2002-08-05 2011-07-26 Torrent Pharmaceuticals Limited Dosage form
WO2004024184A1 (ja) * 2002-09-11 2004-03-25 Takeda Pharmaceutical Company Limited 徐放性製剤
KR20050067418A (ko) 2002-10-18 2005-07-01 머크 앤드 캄파니 인코포레이티드 당뇨병을 치료 또는 예방하기 위한 베타-아미노헤테로사이클릭 디펩티딜 펩티다제 억제제
DE60332856D1 (de) 2002-10-23 2010-07-15 Bristol Myers Squibb Co Auf glycinnitril basierende hemmer der dipeptidylpeptidase iv
AR050615A1 (es) 2004-08-27 2006-11-08 Novartis Ag Composiciones farmaceuticas para la administracion oral

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ROYCE, A., et al. "Alternative Granulation Technique: Melt Granulation", Drug Development and Industrial Pharmacy (1996), Vol. 22, issues 9 and 10, pages 917-924. *

Also Published As

Publication number Publication date
KR20160017123A (ko) 2016-02-15
TWI402082B (zh) 2013-07-21
EP1786401B1 (en) 2017-08-16
ES2647671T3 (es) 2017-12-26
BRPI0514682A (pt) 2008-06-17
US20080050443A1 (en) 2008-02-28
PT1786401T (pt) 2017-11-22
MX2007002253A (es) 2007-04-20
TW200613005A (en) 2006-05-01
EP1786401A1 (en) 2007-05-23
CA2575499A1 (en) 2006-03-02
WO2006021455A1 (en) 2006-03-02
KR20190006612A (ko) 2019-01-18
KR101613775B1 (ko) 2016-04-19
JP5147399B2 (ja) 2013-02-20
DK1786401T3 (da) 2017-11-27
JP2008510764A (ja) 2008-04-10
KR20070049646A (ko) 2007-05-11
BRPI0514682B1 (pt) 2019-06-04
KR20130043697A (ko) 2013-04-30
KR20220061249A (ko) 2022-05-12
SI1786401T1 (sl) 2017-12-29
BRPI0514682B8 (pt) 2021-05-25
KR20160136465A (ko) 2016-11-29
CN101010068B (zh) 2013-05-22
PL1786401T3 (pl) 2018-01-31
KR20170103039A (ko) 2017-09-12
HUE034653T2 (hu) 2018-02-28
PE20060652A1 (es) 2006-08-11
AU2005276583A1 (en) 2006-03-02
RU2007110953A (ru) 2008-10-10
MY144297A (en) 2011-08-29
KR20200087870A (ko) 2020-07-21
RU2383332C2 (ru) 2010-03-10
EP3087975A1 (en) 2016-11-02
CN101010068A (zh) 2007-08-01
AR050615A1 (es) 2006-11-08

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired