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PE20001227A1 - PROCESSES TO PRODUCE AN ISOTRETINOIN COMPOSITION - Google Patents

PROCESSES TO PRODUCE AN ISOTRETINOIN COMPOSITION

Info

Publication number
PE20001227A1
PE20001227A1 PE1999001072A PE00107299A PE20001227A1 PE 20001227 A1 PE20001227 A1 PE 20001227A1 PE 1999001072 A PE1999001072 A PE 1999001072A PE 00107299 A PE00107299 A PE 00107299A PE 20001227 A1 PE20001227 A1 PE 20001227A1
Authority
PE
Peru
Prior art keywords
isotretinoin
produce
size
processes
vehicle
Prior art date
Application number
PE1999001072A
Other languages
Spanish (es)
Inventor
Navnit Hargovindas Shah
Hashim A Ahmed
Martin Howard Infeld
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 PE20001227A1 publication Critical patent/PE20001227A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic 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
    • A61K31/203Retinoic acids ; Salts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/10Anti-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 Containing Plant Substances (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

SE REFIERE A UN PROCESO PARA LA ELABORACION DE UNA COMPOSICION DE ISOTRETINOINA MICRONIZADA DE TAMANO DE PARTICULA DE 5µm A 20µm SUSPENDIDA EN UN VEHICULO OLEOSO QUE COMPRENDE a)DISPERSAR ISOTRETINOINA CON TAMANO DE PATICULA SUPERIOR A 20 µm EN EL VEHICULO OLEOSO PARA FORMAR UNA SUSPENSION QUE CONTIENE 1% A 70% EN PESO DE ISOTRETINOINA; b)SOMETER DICHA SUSPENSION A MEDIOS MECANICOS COMO LA MOLTURACION HUMEDA, HOMOGENIZACION POR ELEVADA CIZALLADURA, MICRONIZACION POR PROPULSION LIQUIDA QUE PRODUCEN CIZALLADURA, IMPACTO, CAVITACION O FRICCION, PARA REDUCIR EL TAMANO DE PARTICULA DE LA ISOTRETINOINA; EL VEHICULO OLEOSO PUEDE SER ACEITE DE SEMILLA DE SOJA, ACEITE DE CACAHUATE, ACEITE DE OLIVA, TRIGLICERIDO DE ACIDO GRASO C6-C18, POLIETILENGLICOL, TRIESTER DE PROPILENGLICOL. LA ISOTRETINOINA SE UTILIZA PARA EL TRATAMIENTO DE ACNE CISTICOIT REFERS TO A PROCESS FOR THE ELABORATION OF A MICRONIZED ISOTRETINOIN COMPOSITION OF A PARTICLE SIZE FROM 5µm TO 20µm SUSPENDED IN AN OILY VEHICLE, INCLUDING a) DISPERSING ISOTRETINOIN WITH A SIZE OF PATICULA OR FORMING IN THE VEHICLE GREATER THAN 20 µm CONTAINS 1% TO 70% BY WEIGHT OF ISOTRETINOIN; b) SUBMIT SUCH SUSPENSION TO MECHANICAL MEANS SUCH AS WET MOLTURATION, HOMOGENIZATION BY HIGH SHEAR, MICRONIZATION BY LIQUID PROPULSION THAT PRODUCE SHEAR, IMPACT, CAVITATION OR FRICTION, TO REDUCE THE ISOLATION OF PARTICULAR SIZE; THE OILY VEHICLE MAY BE SOYBEAN SEED OIL, PEANUT OIL, OLIVE OIL, C6-C18 FATTY ACID TRIGLYCERIDE, POLYETHYLENE GLYCOL, PROPYLENE GLYCOL TRIESTER. ISOTRETINOIN IS USED FOR THE TREATMENT OF CYSTAL ACNE

PE1999001072A 1998-10-30 1999-10-26 PROCESSES TO PRODUCE AN ISOTRETINOIN COMPOSITION PE20001227A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US10633198P 1998-10-30 1998-10-30

Publications (1)

Publication Number Publication Date
PE20001227A1 true PE20001227A1 (en) 2000-11-06

Family

ID=22310843

Family Applications (1)

Application Number Title Priority Date Filing Date
PE1999001072A PE20001227A1 (en) 1998-10-30 1999-10-26 PROCESSES TO PRODUCE AN ISOTRETINOIN COMPOSITION

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) NO20012014D0 (en)
PE (1) PE20001227A1 (en)
TR (1) TR200101156T2 (en)
WO (1) WO2000025772A1 (en)
ZA (1) ZA200102731B (en)

Families Citing this family (31)

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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
EP1318791B1 (en) 2000-09-22 2004-07-07 Galephar M/F Pharmaceutical semi-solid composition of isotretinoin
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
US10022348B2 (en) 2009-05-20 2018-07-17 Sun Pharmaceutical Industries Limited Topical solution of isotretinoin
CA2762391C (en) 2009-05-20 2017-02-07 Ranbaxy Laboratories Limited Liquid dosage forms of isotretinoin
EP2432453A2 (en) 2009-05-20 2012-03-28 Ranbaxy Laboratories Limited Topical retinoid solutions
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
MA40312A (en) 2014-05-29 2017-04-05 Sun Pharmaceutical Ind Ltd Oral pharmaceutical composition of isotretinoin
CA2950533A1 (en) * 2014-06-02 2015-12-10 Sun Pharmaceutical Industries Limited 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
US20170246187A1 (en) 2014-08-28 2017-08-31 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
MX2017015137A (en) * 2015-05-25 2018-03-28 Sun Pharmaceutical Ind Ltd Once daily oral pharmaceutical composition of isotretinoin.
WO2017203365A1 (en) 2016-05-26 2017-11-30 Dr. Reddy's Laboratiories Ltd. Pharmaceutical compositions for treating acne
WO2018098501A1 (en) 2016-11-28 2018-05-31 Lipocine Inc. Oral testosterone undecanoate therapy
US12016830B2 (en) 2022-07-01 2024-06-25 Acrotech Biopharma, LLC Pharmaceutical compositions comprising isotretinoin and processes for preparation and uses thereof

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
EP1131068A1 (en) 2001-09-12
KR20010073226A (en) 2001-07-31
AR020999A1 (en) 2002-06-05
NO20012014L (en) 2001-04-24
JP2002528492A (en) 2002-09-03
AU1044400A (en) 2000-05-22
CA2347098A1 (en) 2000-05-11
NO20012014D0 (en) 2001-04-24
BR9914932A (en) 2001-07-10
WO2000025772A1 (en) 2000-05-11
TR200101156T2 (en) 2001-08-21
CN1324235A (en) 2001-11-28
ZA200102731B (en) 2002-07-03

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