BR9914932A - Process for the manufacture of an isotretinoin composition, micronized isotretinoin composition, unit dosage form for enteral administration and pharmaceutical composition in unit form - Google Patents

Process for the manufacture of an isotretinoin composition, micronized isotretinoin composition, unit dosage form for enteral administration and pharmaceutical composition in unit form

Info

Publication number
BR9914932A
BR9914932A BR9914932-0A BR9914932A BR9914932A BR 9914932 A BR9914932 A BR 9914932A BR 9914932 A BR9914932 A BR 9914932A BR 9914932 A BR9914932 A BR 9914932A
Authority
BR
Brazil
Prior art keywords
composition
isotretinoin
micronized
unit dosage
dosage form
Prior art date
Application number
BR9914932-0A
Other languages
Portuguese (pt)
Inventor
Hashim A Ahmed
Martin Howard Infeld
Navnit Hargovindas Shah
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of BR9914932A publication Critical patent/BR9914932A/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
    • A61K9/48—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
    • 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
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/203—Retinoic acids ; Salts thereof
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

<B><MU>PROCESSO PARA A MANUFATURA DE UMA COMPOSIçãO DE ISOTRETINOìNA, COMPOSIçãO DE ISOTRETINOìNA MICRONIZADA, FORMA DE DOSAGEM UNITáRIA PARA ADMINISTRAçãO ENTERAL E COMPOSIçãO FARMACêUTICA NA FORMA DE DOSAGEM UNITáRIA<MV><D> Expõe-se um processo para preparar uma composição de isotretinoína micronizada. O processo é realizado pela micronização da isotretinoína enquanto se encontra en suspensão em um veículo oleoso. Expõem-se igualmente composições de isotretinoína micronizada e formas de dosagem unitária que contêm as composições. Algumas destas composições são superiores às composições conhecidas com relação ao efeito alimentício.<B> <MU> PROCESS FOR MANUFACTURING AN ISOTRETINOIN COMPOSITION, MICRONIZED ISOTRETINOIN COMPOSITION, UNIT DOSAGE FORM FOR ENTERAL ADMINISTRATION AND PHARMACEUTICAL COMPOSITION IN UNIT DOSAGE FORM <MV> micronized isotretinoin composition. The process is carried out by micronizing the isotretinoin while it is suspended in an oily vehicle. Micronized isotretinoin compositions and unit dosage forms containing the compositions are also exposed. Some of these compositions are superior to the known compositions with respect to the food effect.

BR9914932-0A 1998-10-30 1999-10-29 Process for the manufacture of an isotretinoin composition, micronized isotretinoin composition, unit dosage form for enteral administration and pharmaceutical composition in unit form BR9914932A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10633198P 1998-10-30 1998-10-30
PCT/EP1999/008208 WO2000025772A1 (en) 1998-10-30 1999-10-29 Compositions of and process for producing isotretinoin having low particle size

Publications (1)

Publication Number Publication Date
BR9914932A true BR9914932A (en) 2001-07-10

Family

ID=22310843

Family Applications (1)

Application Number Title Priority Date Filing Date
BR9914932-0A BR9914932A (en) 1998-10-30 1999-10-29 Process for the manufacture of an isotretinoin composition, micronized isotretinoin composition, unit dosage form for enteral administration and pharmaceutical composition in unit form

Country Status (13)

Country Link
EP (1) EP1131068A1 (en)
JP (1) JP2002528492A (en)
KR (1) KR20010073226A (en)
CN (1) CN1324235A (en)
AR (1) AR020999A1 (en)
AU (1) AU1044400A (en)
BR (1) BR9914932A (en)
CA (1) CA2347098A1 (en)
NO (1) NO20012014L (en)
PE (1) PE20001227A1 (en)
TR (1) TR200101156T2 (en)
WO (1) WO2000025772A1 (en)
ZA (1) ZA200102731B (en)

Families Citing this family (30)

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US7374779B2 (en) 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
DE19932157A1 (en) 1999-07-13 2001-01-18 Pharmasol Gmbh Process for the gentle production of ultra-fine microparticles and nanoparticles
FR2807662A1 (en) * 2000-04-12 2001-10-19 Cll Pharma PROCESS FOR STABILIZING THE SIZE OF AN ACTIVE INGREDIENT DISPERSE IN A LIQUID AND ITS APPLICATIONS
IN192188B (en) * 2000-06-16 2004-03-13 Ranbaxy Lab Ltd
PT1318791E (en) 2000-09-22 2004-11-30 Galephar M F ISOTRETINOIN SEMI-SOLID PHARMACEUTICAL COMPOSITION
EA200400782A1 (en) * 2001-12-06 2005-08-25 Рэнбакси Лабораториз Лимитед COMPOSITION OF ISOTRETINOININ WITH CRUSHING COMPONENTS UNDER THE DEGREE OF NANOPARTICLES
EP1527774A1 (en) 2003-11-03 2005-05-04 Basilea Pharmaceutica AG New formulation for retinoid-containing soft gelatin capsules
SE0303135D0 (en) * 2003-11-25 2003-11-25 Lipocore Holding Ab Controlled food effect composition
CZ300424B6 (en) * 2006-06-20 2009-05-13 Pliva - Lachema A. S. Pharmaceutical composition for peroral administration
KR101434706B1 (en) * 2007-02-16 2014-08-26 아스카 세이야쿠 가부시키가이샤 Pharmaceutical composition containing fine particle oil-based suspension
US11304960B2 (en) 2009-01-08 2022-04-19 Chandrashekar Giliyar Steroidal compositions
WO2010109259A1 (en) * 2009-03-26 2010-09-30 Grufarcol Ltda Method for preparing soft gel formulations of liquid isotretinoin and formulations obtained
EP3006021A1 (en) 2009-05-20 2016-04-13 Ranbaxy Laboratories Limited Topical retinoid solutions
CN102802729A (en) 2009-05-20 2012-11-28 兰贝克赛实验室有限公司 Liquid dosage forms of isotretinoin
US10022348B2 (en) 2009-05-20 2018-07-17 Sun Pharmaceutical Industries Limited Topical solution of isotretinoin
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US9358241B2 (en) 2010-11-30 2016-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
US20120148675A1 (en) 2010-12-10 2012-06-14 Basawaraj Chickmath Testosterone undecanoate compositions
US9078925B2 (en) 2012-06-18 2015-07-14 Galephar Pharmaceutical Research, Inc. Pharmaceutical semi-solid composition of isotretinoin
JP6018845B2 (en) * 2012-09-03 2016-11-02 三生医薬株式会社 Method for producing capsule containing ultrafine powder
RU2016150863A (en) 2014-05-29 2018-07-03 Сан Фармасьютикал Индастриз Лимитед ORAL PHARMACEUTICAL COMPOSITION OF ISOTRETINOIN
MA40313A (en) * 2014-06-02 2017-04-05 Sun Pharmaceutical Ind Ltd Oral pharmaceutical composition of isotretinoin
CA2956831A1 (en) 2014-07-31 2016-02-04 Sun Pharmaceutical Industries Limited Oral pharmaceutical composition of isotretinoin
US9498485B2 (en) 2014-08-28 2016-11-22 Lipocine Inc. Bioavailable solid state (17-β)-hydroxy-4-androsten-3-one esters
WO2016033549A2 (en) 2014-08-28 2016-03-03 Lipocine Inc. (17-ß)-3-OXOANDROST-4-EN-17-YL TRIDECANOATE COMPOSITIONS AND METHODS OF THEIR PREPARATION AND USE
MA40781A (en) * 2014-10-01 2017-08-08 Sun Pharmaceutical Ind Ltd PHARMACEUTICAL COMPOSITION OF LOW DOSAGE ISOTRETINOIN FOR ORAL USE
US9750711B2 (en) * 2014-10-01 2017-09-05 Sun Pharmaceutical Industries Limited Low dose oral pharmaceutical composition of isotretinoin
RU2017141029A (en) * 2015-05-25 2019-06-25 Сан Фармасьютикал Индастриз Лимитед PHARMACEUTICAL ORAL COMPOSITION OF ISOTRETINOIN FOR APPLICATION ONCE AGAIN DAY
WO2017203365A1 (en) 2016-05-26 2017-11-30 Dr. Reddy's Laboratiories Ltd. Pharmaceutical compositions for treating acne
JP2020503269A (en) 2016-11-28 2020-01-30 リポカイン インコーポレーテッド Oral testosterone undecanoate therapy

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2557615C2 (en) * 1975-12-20 1985-08-14 Bayer Ag, 5090 Leverkusen New niclosamide suspension formulations
DE3119383A1 (en) * 1981-05-15 1982-12-02 Basf Ag, 6700 Ludwigshafen METHOD FOR PRODUCING FINE DISTRIBUTED, POWDERED CAROTINO PREPARATIONS
CA1282326C (en) * 1984-12-14 1991-04-02 Paul J. Jarosz Pharmaceutical composition containing 13-cis vitamin a acid as the active ingredient

Also Published As

Publication number Publication date
WO2000025772A1 (en) 2000-05-11
KR20010073226A (en) 2001-07-31
PE20001227A1 (en) 2000-11-06
AR020999A1 (en) 2002-06-05
EP1131068A1 (en) 2001-09-12
CA2347098A1 (en) 2000-05-11
ZA200102731B (en) 2002-07-03
NO20012014D0 (en) 2001-04-24
JP2002528492A (en) 2002-09-03
CN1324235A (en) 2001-11-28
NO20012014L (en) 2001-04-24
AU1044400A (en) 2000-05-22
TR200101156T2 (en) 2001-08-21

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Legal Events

Date Code Title Description
B11A Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing
B11Y Definitive dismissal acc. article 33 of ipl - extension of time limit for request of examination expired