WO2005065656A3 - Stabilized pharmaceutical solid compositions of low-solubility drugs, poloxamers, and stabilizing polymers - Google Patents

Stabilized pharmaceutical solid compositions of low-solubility drugs, poloxamers, and stabilizing polymers Download PDF

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Publication number
WO2005065656A3
WO2005065656A3 PCT/IB2004/004260 IB2004004260W WO2005065656A3 WO 2005065656 A3 WO2005065656 A3 WO 2005065656A3 IB 2004004260 W IB2004004260 W IB 2004004260W WO 2005065656 A3 WO2005065656 A3 WO 2005065656A3
Authority
WO
WIPO (PCT)
Prior art keywords
low
solid compositions
poloxamers
pharmaceutical solid
stabilizing polymers
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/IB2004/004260
Other languages
French (fr)
Other versions
WO2005065656A2 (en
Inventor
Marshall David Crew
Ravi Mysore Shanker
Daniel Tod Smithey
Warren Kenyon Miller
Dwayne Thomas Friesen
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.)
Pfizer Products Inc
Original Assignee
Pfizer Products Inc
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
Priority to MXPA06007512A priority Critical patent/MXPA06007512A/en
Priority to DE602004031767T priority patent/DE602004031767D1/en
Priority to AT04806432T priority patent/ATE500819T1/en
Priority to US10/596,885 priority patent/US20070148232A1/en
Priority to CA002551254A priority patent/CA2551254A1/en
Priority to BRPI0418294-4A priority patent/BRPI0418294A/en
Application filed by Pfizer Products Inc filed Critical Pfizer Products Inc
Priority to JP2006546396A priority patent/JP2007517015A/en
Priority to EP04806432A priority patent/EP1701703B1/en
Publication of WO2005065656A2 publication Critical patent/WO2005065656A2/en
Anticipated expiration legal-status Critical
Publication of WO2005065656A3 publication Critical patent/WO2005065656A3/en
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
    • A61K9/14—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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Solid compositions with improved physical stability comprise an amorphous, low-solubility drug, a poloxamer, and a stabilizing polymer. The compositions provide good physical stability during storage and concentration enhancement of dissolved drug when administered to an aqueous environment of use.
PCT/IB2004/004260 2003-12-31 2004-12-20 Stabilized pharmaceutical solid compositions of low-solubility drugs, poloxamers, and stabilizing polymers Ceased WO2005065656A2 (en)

Priority Applications (8)

Application Number Priority Date Filing Date Title
DE602004031767T DE602004031767D1 (en) 2003-12-31 2004-12-20 STABILIZED PHARMACEUTICAL SOLIDS COMPOSITIONS OF MEDIUM SOLUBILITY MEDICAMENTS, POLOXAMERS AND STABILIZING POLYMERS
AT04806432T ATE500819T1 (en) 2003-12-31 2004-12-20 STABILIZED PHARMACEUTICAL SOLID COMPOSITIONS OF LOW SOLUBILITY DRUGS, POLOXAMERS AND STABILIZING POLYMERS
US10/596,885 US20070148232A1 (en) 2003-12-31 2004-12-20 Stabilized pharmaceutical solid compositions of low-solubility drugs and poloxamers, and stabilizing polymers
CA002551254A CA2551254A1 (en) 2003-12-31 2004-12-20 Stabilized pharmaceutical solid compositions of low-solubility drugs, poloxamers, and stabilizing polymers
BRPI0418294-4A BRPI0418294A (en) 2003-12-31 2004-12-20 stabilized solid pharmaceutical compositions of low solubility drugs, poloxamers and stabilizing polymers
MXPA06007512A MXPA06007512A (en) 2003-12-31 2004-12-20 Stabilized pharmaceutical solid compositions of low-solubility drugs, poloxamers, and stabilizing polymers.
JP2006546396A JP2007517015A (en) 2003-12-31 2004-12-20 Stabilized pharmaceutical solid composition of low solubility drug, poloxamer and stabilizing polymer
EP04806432A EP1701703B1 (en) 2003-12-31 2004-12-20 Stabilized pharmaceutical solid compositions of low-solubility drugs, poloxamers and stabilizing polymers

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US53384803P 2003-12-31 2003-12-31
US60/533,848 2003-12-31

Publications (2)

Publication Number Publication Date
WO2005065656A2 WO2005065656A2 (en) 2005-07-21
WO2005065656A3 true WO2005065656A3 (en) 2006-07-13

Family

ID=34748971

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2004/004260 Ceased WO2005065656A2 (en) 2003-12-31 2004-12-20 Stabilized pharmaceutical solid compositions of low-solubility drugs, poloxamers, and stabilizing polymers

Country Status (9)

Country Link
US (1) US20070148232A1 (en)
EP (1) EP1701703B1 (en)
JP (1) JP2007517015A (en)
AT (1) ATE500819T1 (en)
BR (1) BRPI0418294A (en)
CA (1) CA2551254A1 (en)
DE (1) DE602004031767D1 (en)
MX (1) MXPA06007512A (en)
WO (1) WO2005065656A2 (en)

Families Citing this family (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008511607A (en) * 2004-08-31 2008-04-17 ファイザー・プロダクツ・インク Pharmaceutical dosage form comprising a low-solubility drug and a polymer
RU2382648C2 (en) * 2004-12-03 2010-02-27 Мерк Энд Ко., Инк. Pharmaceutical composition of carboxamide inhibitors of hiv integrase, containing composition with controlled rate of release
US20090304786A1 (en) * 2005-11-25 2009-12-10 Viswaprasad Varanasi Stable Dosage Forms of an Antidepressant
GB0613925D0 (en) * 2006-07-13 2006-08-23 Unilever Plc Improvements relating to nanodispersions
TWI489984B (en) 2006-08-04 2015-07-01 Wyeth Corp Formulations for parenteral delivery of compounds and uses thereof
PE20081506A1 (en) * 2006-12-12 2008-12-09 Infinity Discovery Inc ANSAMYCIN FORMULATIONS
KR20080062430A (en) * 2006-12-29 2008-07-03 에스케이케미칼주식회사 Oral administration formulation containing atorvastatin with excellent storage stability
HRP20191104T1 (en) 2007-09-25 2019-09-20 Solubest Ltd. Compositions comprising lipophilic active compounds and method for their preparation
SG174488A1 (en) * 2009-03-19 2011-10-28 Shionogi & Co Solid preparation containing npy y5 receptor antagonist
JP5654002B2 (en) 2009-05-13 2015-01-14 ビーエーエスエフ ソシエタス・ヨーロピアＢａｓｆ Ｓｅ Solid pharmaceutical preparation comprising a polyether-based copolymer in combination with a slightly water-soluble polymer
BR112012006056A2 (en) * 2009-09-18 2016-03-29 Basf Se dosage form
AU2010313571B2 (en) 2009-10-26 2014-07-31 Merck Sharp & Dohme Llc Solid pharmaceutical compositions containing an integrase inhibitor
EP2366378A1 (en) 2010-03-01 2011-09-21 Dexcel Pharma Technologies Ltd. Sustained-release donepezil formulations
TWI605814B (en) 2010-03-11 2017-11-21 惠氏有限責任公司 Oral preparation and lipophilic salt of METHYLNAL TREXONE
DE102012105512A1 (en) * 2012-06-25 2014-04-24 Hennig Arzneimittel Gmbh & Co. Kg Pharmaceutical form for prolonged release of active ingredients
CN104721141A (en) * 2013-12-18 2015-06-24 博瑞生物医药技术(苏州)有限公司 Antifungal medicament solid dispersion
WO2016004369A1 (en) 2014-07-02 2016-01-07 The Research Foundation For The State University Of New York Surfactant-stripped micelle compositions with high cargo to surfactant ratio
US20160200925A1 (en) * 2015-01-08 2016-07-14 Canon Kabushiki Kaisha Image recording method, ink, and liquid composition
GB2584341B (en) * 2019-05-31 2023-03-01 Gw Res Ltd Cannabinoid formulations

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2394417A (en) * 2002-10-24 2004-04-28 Novartis Ag Solid dispersion comprising a piperidine substance P antagonist and a carrier

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US6368622B2 (en) * 1999-01-29 2002-04-09 Abbott Laboratories Process for preparing solid formulations of lipid regulating agents with enhanced dissolution and absorption
ES2307482T3 (en) * 1999-02-10 2008-12-01 Pfizer Products Inc. SOLID PHARMACEUTICAL DISPERSIONS.
US6248363B1 (en) * 1999-11-23 2001-06-19 Lipocine, Inc. Solid carriers for improved delivery of active ingredients in pharmaceutical compositions
US6395300B1 (en) * 1999-05-27 2002-05-28 Acusphere, Inc. Porous drug matrices and methods of manufacture thereof
US6264981B1 (en) * 1999-10-27 2001-07-24 Anesta Corporation Oral transmucosal drug dosage using solid solution
JP2004500358A (en) * 1999-12-08 2004-01-08 ファルマシア　コーポレイション Celecoxib in the solid state with increased bioavailability
US20010036959A1 (en) * 2000-04-03 2001-11-01 Gabel Rolf Dieter Carvedilol-hydrophilic solutions
AU2001257115B2 (en) * 2000-04-20 2005-01-27 Rtp Pharma Inc. Improved water-insoluble drug particle process
US6316029B1 (en) * 2000-05-18 2001-11-13 Flak Pharma International, Ltd. Rapidly disintegrating solid oral dosage form
KR20020014570A (en) * 2000-08-18 2002-02-25 김충섭 Process for Preparing Amorphous-type Ipriflavone by Solid-Dispersion
BR0307332A (en) * 2002-02-01 2004-12-07 Pfizer Prod Inc Controlled Release Pharmaceutical Dosage Forms of a Cholesterol Ester Transfer Protein Inhibitor
PL372247A1 (en) * 2002-02-01 2005-07-11 Pfizer Products Inc. Method for making homogeneous spray-dried solid amorphous drug dispersions utilizing modified spray-drying apparatus

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2394417A (en) * 2002-10-24 2004-04-28 Novartis Ag Solid dispersion comprising a piperidine substance P antagonist and a carrier

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
B. WOLF, INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 156, 1997, pages 97 - 107, XP002371087 *

Also Published As

Publication number Publication date
DE602004031767D1 (en) 2011-04-21
BRPI0418294A (en) 2007-05-02
WO2005065656A2 (en) 2005-07-21
MXPA06007512A (en) 2006-08-31
US20070148232A1 (en) 2007-06-28
CA2551254A1 (en) 2005-07-21
EP1701703A2 (en) 2006-09-20
ATE500819T1 (en) 2011-03-15
JP2007517015A (en) 2007-06-28
EP1701703B1 (en) 2011-03-09

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