WO2011090724A3 - Gastroretentive solid oral dosage forms with lipid-based low-density excipient - Google Patents

Gastroretentive solid oral dosage forms with lipid-based low-density excipient Download PDF

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Publication number
WO2011090724A3
WO2011090724A3 PCT/US2010/062261 US2010062261W WO2011090724A3 WO 2011090724 A3 WO2011090724 A3 WO 2011090724A3 US 2010062261 W US2010062261 W US 2010062261W WO 2011090724 A3 WO2011090724 A3 WO 2011090724A3
Authority
WO
WIPO (PCT)
Prior art keywords
gastroretentive
lipid
dosage forms
oral dosage
solid oral
Prior art date
Application number
PCT/US2010/062261
Other languages
French (fr)
Other versions
WO2011090724A2 (en
Inventor
Laman Lynn Alani
Jim H. Kou
Shook-Fong Chin
Original Assignee
Impax Laboratories, 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
Application filed by Impax Laboratories, Inc. filed Critical Impax Laboratories, Inc.
Publication of WO2011090724A2 publication Critical patent/WO2011090724A2/en
Publication of WO2011090724A3 publication Critical patent/WO2011090724A3/en

Links

Classifications

    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/14—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
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The disclosure provides multiparticulate systems that give release of active agents with a narrow window of absorption such that there is bioavailability to a patient. The disclosure provides a composition comprising microparticulates comprising a low density excipient and an active agent dispersed therein, wherein the ratio of low-density excipient to active agent is greater than 1:1.
PCT/US2010/062261 2009-12-29 2010-12-28 Gastroretentive solid oral dosage forms with lipid-based low-density excipient WO2011090724A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US29081509P 2009-12-29 2009-12-29
US61/290,815 2009-12-29

Publications (2)

Publication Number Publication Date
WO2011090724A2 WO2011090724A2 (en) 2011-07-28
WO2011090724A3 true WO2011090724A3 (en) 2011-11-17

Family

ID=44307484

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2010/062261 WO2011090724A2 (en) 2009-12-29 2010-12-28 Gastroretentive solid oral dosage forms with lipid-based low-density excipient

Country Status (1)

Country Link
WO (1) WO2011090724A2 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10026698A1 (en) 2000-05-30 2001-12-06 Basf Ag Self-emulsifying active ingredient formulation and use of this formulation
US8377952B2 (en) 2003-08-28 2013-02-19 Abbott Laboratories Solid pharmaceutical dosage formulation
US8025899B2 (en) 2003-08-28 2011-09-27 Abbott Laboratories Solid pharmaceutical dosage form
MX362838B (en) 2012-07-12 2019-02-19 SpecGx LLC Extended release, abuse deterrent pharmaceutical compositions.
CA2949372C (en) 2014-06-02 2023-08-22 Teva Pharmaceutical Industries Ltd. Expandable gastroretentive dosage form
WO2018102799A1 (en) 2016-12-02 2018-06-07 Clexio Biosciences Ltd. Gastric residence system
WO2019111132A1 (en) 2017-12-04 2019-06-13 Clexio Biosciences Ltd. Long acting gastric residence system

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5700410A (en) * 1992-10-16 1997-12-23 Nippon Shinyaku Co., Ltd. Method of manufacturing wax matrices
US20070009596A1 (en) * 2003-05-14 2007-01-11 Bruschi Stefano D L Controlled drug release composition resistant to in vivo mechanic stress
US20080274194A1 (en) * 2004-11-09 2008-11-06 Board Of Regents, The University Of Texas System Stabilized Hme Composition With Small Drug Particles

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5700410A (en) * 1992-10-16 1997-12-23 Nippon Shinyaku Co., Ltd. Method of manufacturing wax matrices
US20070009596A1 (en) * 2003-05-14 2007-01-11 Bruschi Stefano D L Controlled drug release composition resistant to in vivo mechanic stress
US20080274194A1 (en) * 2004-11-09 2008-11-06 Board Of Regents, The University Of Texas System Stabilized Hme Composition With Small Drug Particles

Also Published As

Publication number Publication date
WO2011090724A2 (en) 2011-07-28

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