WO2005011737A3 - Pharmaceutical combinations and formulations with improved stability - Google Patents

Pharmaceutical combinations and formulations with improved stability Download PDF

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Publication number
WO2005011737A3
WO2005011737A3 PCT/GB2004/003305 GB2004003305W WO2005011737A3 WO 2005011737 A3 WO2005011737 A3 WO 2005011737A3 GB 2004003305 W GB2004003305 W GB 2004003305W WO 2005011737 A3 WO2005011737 A3 WO 2005011737A3
Authority
WO
WIPO (PCT)
Prior art keywords
formulations
improved stability
pharmaceutical combinations
stabilising
agent
Prior art date
Application number
PCT/GB2004/003305
Other languages
French (fr)
Other versions
WO2005011737A2 (en
Inventor
Amar Lulla
Geena Malhotra
Original Assignee
Cipla Ltd
Amar Lulla
Geena Malhotra
Wain Christopher Paul
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 Cipla Ltd, Amar Lulla, Geena Malhotra, Wain Christopher Paul filed Critical Cipla Ltd
Publication of WO2005011737A2 publication Critical patent/WO2005011737A2/en
Publication of WO2005011737A3 publication Critical patent/WO2005011737A3/en

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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

In combination, at least one therapeutic agent which is susceptible to degradation, and at least one stabilising agent comprising at least one carbonate salt of an amino acid optionally together with one or more saccharides, whereby the stabilising agent can provide a protective stabilising effect for the at least one therapeutic agent susceptible to degradation when present in a pharmaceutical formulation.
PCT/GB2004/003305 2003-07-30 2004-07-30 Pharmaceutical combinations and formulations with improved stability WO2005011737A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0317877A GB2404336A (en) 2003-07-30 2003-07-30 Stabilisation of therapeutic agents using a carbonate salt of an amino acid, preferably in the presence of a saccharide, & pharmaceutical compositions thereof
GB0317877.9 2003-07-30

Publications (2)

Publication Number Publication Date
WO2005011737A2 WO2005011737A2 (en) 2005-02-10
WO2005011737A3 true WO2005011737A3 (en) 2005-04-21

Family

ID=27799502

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2004/003305 WO2005011737A2 (en) 2003-07-30 2004-07-30 Pharmaceutical combinations and formulations with improved stability

Country Status (2)

Country Link
GB (1) GB2404336A (en)
WO (1) WO2005011737A2 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA011712B1 (en) * 2004-03-29 2009-04-28 Ле Лаборатуар Сервье Process for preparing a solid pharmaceutical composition
SI21800A (en) 2004-05-14 2005-12-31 Krka, Tovarna Zdravil, D.D., Novo Mesto New procedure of synthesis of perindopril
BRPI0513417A (en) * 2004-07-16 2008-05-06 Cipla Ltd stable pharmaceutical composition, uses of a polyol, and a composition, process for preparing a pharmaceutical composition, and method for treating a condition responsive to the administration of an antihistamine
CA2547274A1 (en) * 2005-05-20 2006-11-20 Dr. Reddy's Laboratories Limited Stable desloratadine compositions
FR2917620B1 (en) * 2007-06-25 2009-10-23 Aditec Soc Par Actions Simplif PROCESS FOR PREPARING A GRANULATED FORM
TR200906322A2 (en) 2009-08-17 2011-07-21 Bi̇lgi̇ç Mahmut Granules with improved solubility and stability properties.
CN105125514A (en) * 2015-10-12 2015-12-09 石药集团欧意药业有限公司 Stable enalapril maleate capsules and preparation method thereof

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3392195A (en) * 1963-09-09 1968-07-09 Galat Alexander Amino acid derivatives
FR2305194A1 (en) * 1975-03-26 1976-10-22 Ind C M Stable, effervescent (multi)enzyme compsns. - with glycine sodium carbonate or buffered sodium bicarbonate as the basic component
EP0293975A1 (en) * 1987-05-27 1988-12-07 Akzo N.V. Dry, rapidly soluble, compositions of beta-lactam antibiotics
DE4139017A1 (en) * 1990-11-27 1992-06-04 Egyt Gyogyszervegyeszeti Gyar WAESSED PIROXICAM SOLUTIONS AND METHOD FOR THE PRODUCTION THEREOF
EP0547000A1 (en) * 1991-12-12 1993-06-16 Sandoz Ltd. Stabilized pharmaceutical compositions comprising an HMG-CoA reductase inhibitor compound
WO2000032170A1 (en) * 1998-12-01 2000-06-08 Virbac Preparation of dry compositions soluble in the presence of water and avoiding maillard reaction in dry state and uses

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2021548A1 (en) * 1989-09-01 1991-03-02 Ronald Nash Duvall Effervescent cold or sinus allergy medicine composition having reduced sodium content
US5814337A (en) * 1992-10-07 1998-09-29 Beecham Group Plc Pharmaceutical formulation
JPH05194225A (en) * 1991-11-07 1993-08-03 Yoshitomi Pharmaceut Ind Ltd Stabilized antiulcer agent-containing preparation
JP2594395B2 (en) * 1991-11-27 1997-03-26 吉富製薬株式会社 Stabilization method and formulation of sodium azulene sulfonate
AU2002244865A1 (en) * 2001-03-02 2002-09-19 Dr. Reddy's Laboratories Ltd. Pharmaceutical composition of ibuprofen

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3392195A (en) * 1963-09-09 1968-07-09 Galat Alexander Amino acid derivatives
FR2305194A1 (en) * 1975-03-26 1976-10-22 Ind C M Stable, effervescent (multi)enzyme compsns. - with glycine sodium carbonate or buffered sodium bicarbonate as the basic component
EP0293975A1 (en) * 1987-05-27 1988-12-07 Akzo N.V. Dry, rapidly soluble, compositions of beta-lactam antibiotics
DE4139017A1 (en) * 1990-11-27 1992-06-04 Egyt Gyogyszervegyeszeti Gyar WAESSED PIROXICAM SOLUTIONS AND METHOD FOR THE PRODUCTION THEREOF
EP0547000A1 (en) * 1991-12-12 1993-06-16 Sandoz Ltd. Stabilized pharmaceutical compositions comprising an HMG-CoA reductase inhibitor compound
WO2000032170A1 (en) * 1998-12-01 2000-06-08 Virbac Preparation of dry compositions soluble in the presence of water and avoiding maillard reaction in dry state and uses

Also Published As

Publication number Publication date
GB0317877D0 (en) 2003-09-03
GB2404336A (en) 2005-02-02
WO2005011737A2 (en) 2005-02-10

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