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WO2004022032A3 - Forme posologique pharmaceutique comprenant un compose de sulfite - Google Patents

Forme posologique pharmaceutique comprenant un compose de sulfite Download PDF

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Publication number
WO2004022032A3
WO2004022032A3 PCT/US2003/024044 US0324044W WO2004022032A3 WO 2004022032 A3 WO2004022032 A3 WO 2004022032A3 US 0324044 W US0324044 W US 0324044W WO 2004022032 A3 WO2004022032 A3 WO 2004022032A3
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
pharmaceutical dosage
sulfite compound
fill material
gelatin capsule
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/US2003/024044
Other languages
English (en)
Other versions
WO2004022032A2 (fr
Inventor
Ping Gao
Juliane M Bauer
Gary Ewing
David Sperry
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.)
Pharmacia LLC
Original Assignee
Pharmacia LLC
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 Pharmacia LLC filed Critical Pharmacia LLC
Priority to JP2004534259A priority Critical patent/JP2006500389A/ja
Priority to BR0313064-9A priority patent/BR0313064A/pt
Priority to AU2003257102A priority patent/AU2003257102A1/en
Priority to CA002493974A priority patent/CA2493974A1/fr
Priority to EP03794452A priority patent/EP1526847A2/fr
Priority to MXPA05001272A priority patent/MXPA05001272A/es
Publication of WO2004022032A2 publication Critical patent/WO2004022032A2/fr
Publication of WO2004022032A3 publication Critical patent/WO2004022032A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/485—Inorganic compounds
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/18—Sulfonamides
    • 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
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
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    • 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
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    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A—HUMAN NECESSITIES
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    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/14—Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
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    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds

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  • Health & Medical Sciences (AREA)
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  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Virology (AREA)
  • Psychiatry (AREA)
  • Reproductive Health (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Rheumatology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Addiction (AREA)
  • Hematology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Hospice & Palliative Care (AREA)
  • Obesity (AREA)

Abstract

L'invention a pour objet une forme posologique pharmaceutique comprenant une capsule de gélatine contenant une charge ; ladite charge comprend : (a) un médicament inhibiteur de COX-2 sélectif, peu soluble dans l'eau, et (b) un composé de sulfite présent en une quantité suffisante pour inhiber la réticulation de la gélatine dans ladite capsule de gélatine, lors du stockage de la forme posologique, pour une durée de 6 mois, dans un récipient fermé, maintenu à 40 °C et comprenant 75 % d'humidité relative.
PCT/US2003/024044 2002-07-31 2003-07-31 Forme posologique pharmaceutique comprenant un compose de sulfite Ceased WO2004022032A2 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2004534259A JP2006500389A (ja) 2002-07-31 2003-07-31 亜硫酸塩化合物を含有する医薬剤形
BR0313064-9A BR0313064A (pt) 2002-07-31 2003-07-31 Forma de dosagem farmacêutica compreendendo um composto de sulfito
AU2003257102A AU2003257102A1 (en) 2002-07-31 2003-07-31 Pharmaceutical dosage form comprising a sulfite compound
CA002493974A CA2493974A1 (fr) 2002-07-31 2003-07-31 Forme posologique pharmaceutique comprenant un compose de sulfite
EP03794452A EP1526847A2 (fr) 2002-07-31 2003-07-31 Forme posologique pharmaceutique comprenant un compose de sulfite
MXPA05001272A MXPA05001272A (es) 2002-07-31 2003-07-31 Forma de dosificiacion farmaceutica que comprende un compuesto de sulfito.

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US39980802P 2002-07-31 2002-07-31
US39986202P 2002-07-31 2002-07-31
US39977602P 2002-07-31 2002-07-31
US39986302P 2002-07-31 2002-07-31
US60/399,776 2002-07-31
US60/399,863 2002-07-31
US60/399,808 2002-07-31
US60/399,862 2002-07-31

Publications (2)

Publication Number Publication Date
WO2004022032A2 WO2004022032A2 (fr) 2004-03-18
WO2004022032A3 true WO2004022032A3 (fr) 2004-08-12

Family

ID=31192378

Family Applications (4)

Application Number Title Priority Date Filing Date
PCT/US2003/024042 Ceased WO2004010972A2 (fr) 2002-07-31 2003-07-31 Capsule de gelatine resistant aux pellicules
PCT/US2003/024044 Ceased WO2004022032A2 (fr) 2002-07-31 2003-07-31 Forme posologique pharmaceutique comprenant un compose de sulfite
PCT/US2003/024045 Ceased WO2004010974A2 (fr) 2002-07-31 2003-07-31 Capsule de gelatine a reticulation reduite
PCT/US2003/024043 Ceased WO2004010973A2 (fr) 2002-07-31 2003-07-31 Forme posologique pharmaceutique conservant un profil de dissolution stable au stockage

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2003/024042 Ceased WO2004010972A2 (fr) 2002-07-31 2003-07-31 Capsule de gelatine resistant aux pellicules

Family Applications After (2)

Application Number Title Priority Date Filing Date
PCT/US2003/024045 Ceased WO2004010974A2 (fr) 2002-07-31 2003-07-31 Capsule de gelatine a reticulation reduite
PCT/US2003/024043 Ceased WO2004010973A2 (fr) 2002-07-31 2003-07-31 Forme posologique pharmaceutique conservant un profil de dissolution stable au stockage

Country Status (7)

Country Link
EP (4) EP1526845A2 (fr)
JP (4) JP2006500389A (fr)
AU (4) AU2003257103A1 (fr)
BR (4) BR0313064A (fr)
CA (4) CA2494358A1 (fr)
MX (4) MXPA05001272A (fr)
WO (4) WO2004010972A2 (fr)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8895059B2 (en) 2002-06-05 2014-11-25 Ivax Pharmaceuticals S.R.O. Reduction of cross-linking gelatin in gelatin capsules
KR101364762B1 (ko) 2005-02-17 2014-02-17 신타 파마슈티칼스 코프. 증식성 장애의 치료를 위한 화합물
US7485323B2 (en) 2005-05-31 2009-02-03 Gelita Ag Process for making a low molecular weight gelatine hydrolysate and gelatine hydrolysate compositions
PT1906938E (pt) * 2005-07-26 2011-01-17 Nicox Sa Formulação farmacêutica de derivados de nitrooxi de aine
JP5503939B2 (ja) * 2009-10-16 2014-05-28 東洋カプセル株式会社 アゼラスチン塩酸塩含有カプセル剤
JP6887456B2 (ja) 2018-07-04 2021-06-16 キャプシュゲル・ベルジウム・エヌ・ヴィ 白色化剤として界面活性剤又は界面活性剤と塩を含有する皮膜形成性組成物
US11364478B2 (en) * 2019-05-22 2022-06-21 Mezzimatic, LLC Method of manufacturing throwable paintballs and paintballs made therefrom
AR124178A1 (es) * 2020-12-01 2023-02-22 Lg Chemical Ltd Formulación compuesta para administración oral que comprende ácido 1-(3-ciano-1-isopropil-indol-5-il)pirazol-4-carboxílico y un proceso para su preparación
CN113230241A (zh) * 2021-06-11 2021-08-10 北京畅盛医药科技有限公司 三羟甲基氨基甲烷盐在治疗心脑血管病的药物中的应用

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2204401A1 (fr) * 1972-11-01 1974-05-24 Meiji Seika Co
US4590183A (en) * 1985-04-22 1986-05-20 Sterling Drug Inc. Gastric cytoprotection with sodium thiosulfate in oral administration of aspirin
EP0672414A2 (fr) * 1994-03-15 1995-09-20 Senju Pharmaceutical Co., Ltd. Méthode pour la stabilisation du pranoprofène et composition stable liquide contenant du pranoprofène
EP0695544A1 (fr) * 1994-08-05 1996-02-07 Shionogi & Co., Ltd. Capsules en gélatine dure résistantes à la dénaturation et procédé de leur préparation

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4349529A (en) * 1980-04-14 1982-09-14 E. R. Squibb & Sons, Inc. Diagnostic and therapeutic capsules and method of producing
FR2617047B1 (fr) * 1987-06-23 1991-05-10 Sanofi Sa Composition de gelatine resistant au tannage, capsules a base de cette composition et leur application pharmaceutique, notamment au fenofibrate
JP2790659B2 (ja) * 1989-06-30 1998-08-27 帝国臓器製薬株式会社 ゼラチンカプセル剤
IT1269583B (it) * 1994-04-26 1997-04-08 Bayer Italia Spa Preparazioni farmaceutiche a base di una soluzione di ketoprofene in capsule di gelatina molle e metodo per la loro produzione
US5620704A (en) * 1994-11-07 1997-04-15 Warner-Lambert Company Process for stabilizing gelatin products
US7115565B2 (en) * 2001-01-18 2006-10-03 Pharmacia & Upjohn Company Chemotherapeutic microemulsion compositions of paclitaxel with improved oral bioavailability

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2204401A1 (fr) * 1972-11-01 1974-05-24 Meiji Seika Co
US4590183A (en) * 1985-04-22 1986-05-20 Sterling Drug Inc. Gastric cytoprotection with sodium thiosulfate in oral administration of aspirin
EP0672414A2 (fr) * 1994-03-15 1995-09-20 Senju Pharmaceutical Co., Ltd. Méthode pour la stabilisation du pranoprofène et composition stable liquide contenant du pranoprofène
EP0695544A1 (fr) * 1994-08-05 1996-02-07 Shionogi & Co., Ltd. Capsules en gélatine dure résistantes à la dénaturation et procédé de leur préparation

Also Published As

Publication number Publication date
AU2003257981A8 (en) 2004-02-16
AU2003257982A8 (en) 2004-02-16
AU2003257981A1 (en) 2004-02-16
BR0313149A (pt) 2005-06-28
JP2005538994A (ja) 2005-12-22
BR0313150A (pt) 2005-06-28
CA2494358A1 (fr) 2004-02-05
WO2004010974A3 (fr) 2004-08-05
EP1526847A2 (fr) 2005-05-04
AU2003257102A8 (en) 2004-03-29
EP1526846A2 (fr) 2005-05-04
WO2004010974A2 (fr) 2004-02-05
CA2494069A1 (fr) 2004-02-05
MXPA05000862A (es) 2005-04-19
AU2003257103A8 (en) 2004-02-16
MXPA05001166A (es) 2005-05-16
JP2006500389A (ja) 2006-01-05
EP1526844A2 (fr) 2005-05-04
MXPA05001272A (es) 2005-04-28
JP2005538102A (ja) 2005-12-15
WO2004010973A2 (fr) 2004-02-05
BR0312875A (pt) 2005-06-28
AU2003257982A1 (en) 2004-02-16
WO2004010972A2 (fr) 2004-02-05
AU2003257102A1 (en) 2004-03-29
MXPA05001167A (es) 2005-05-16
JP2005538993A (ja) 2005-12-22
CA2493980A1 (fr) 2004-02-05
AU2003257103A1 (en) 2004-02-16
EP1526845A2 (fr) 2005-05-04
CA2493974A1 (fr) 2004-03-18
WO2004022032A2 (fr) 2004-03-18
BR0313064A (pt) 2005-06-28
WO2004010972A3 (fr) 2004-07-29
WO2004010973A3 (fr) 2004-08-05

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