ES2179385T3 - Preformulaciones homogeneas que contienen esteroides en alta concentracion, para la preparacion de composiciones farmaceuticas solidas y semisolidas debilmente dosificadas. - Google Patents

Preformulaciones homogeneas que contienen esteroides en alta concentracion, para la preparacion de composiciones farmaceuticas solidas y semisolidas debilmente dosificadas.

Info

Publication number
ES2179385T3
ES2179385T3 ES97953625T ES97953625T ES2179385T3 ES 2179385 T3 ES2179385 T3 ES 2179385T3 ES 97953625 T ES97953625 T ES 97953625T ES 97953625 T ES97953625 T ES 97953625T ES 2179385 T3 ES2179385 T3 ES 2179385T3
Authority
ES
Spain
Prior art keywords
steroid
adjuvant
solid
preformulation
particles
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.)
Expired - Lifetime
Application number
ES97953625T
Other languages
English (en)
Inventor
Detlef Grawe
Peter Hosel
Peter Mollmann
Carsten Timpe
Michael Dittgen
Klaus Matthey
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.)
Jenapharm GmbH and Co KG
Original Assignee
Jenapharm GmbH and Co KG
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 Jenapharm GmbH and Co KG filed Critical Jenapharm GmbH and Co KG
Application granted granted Critical
Publication of ES2179385T3 publication Critical patent/ES2179385T3/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • 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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug

Landscapes

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

Abstract

LAS PREFORMULACIONES QUE CONTIENEN ESTEROIDES EN ELEVADA CONCENTRACION SON APROPIADAS PARA PREPARAR PREPARACIONES FARMACEUTICAS SOLIDAS Y SEMISOLIDAS CON BAJA DOSIFICACION CON UNA CONCENTRACION DE 0,001 A 1 % EN PESO DE ESTEROIDES. SE OBTIENEN MEDIANTE EVAPORACION DEL AGENTE DE DISPERSION QUE CONTIENE EL PRINCIPIO ACTIVO ESTEROIDAL A PARTIR DE UNA SUSPENSION QUE LLEVA ADYUVANTES USUALES FARMACEUTICOS, FORMANDOSE UNA NIEBLA DE PULVERIZACION, CUYO DIAMETRO MEDIO DE GOTA ES MAYOR QUE EL DIAMETRO MEDIO DE LAS PARTICULAS DE ADYUVANTE, Y EL MAXIMO TAMAÑO DE GRANO DE LAS PARTICULAS SECAS DE LA PREFORMULACION QUE LLEVAN ESTOS ESTEROIDES ESTA AUMENTADO EN MENOS DEL 30 %, EN RELACION CON EL TAMAÑO DE GRANO DEL ADYUVANTE. DICHAS PREFORMULACIONES SE CARACTERIZAN POR SU HOMOGENEIDAD Y RESISTENCIA A LA DISOCIACION, ESTANDO DISPERSADO FINAMENTE EL PRINCIPIO ACTIVO ESTEROIDAL Y UNIDO INTEGRAMENTE AL ADYUVANTE. SE DESCUBRIO SORPRESIVAMENTE QUE ESTOS TIPOS DE PREFORMULACIONES ESTEROIDALES, EN COMPARACION CONLOS PROCEDIMIENTOS CONVENCIONALES, SE PUEDEN PROCESAR SIN DIFICULTAD PARA OBTENER PREPARACIONES FARMACEUTICAS DE BAJA DOSIS CON MUY BUENA HOMOGENEIDAD Y BUENA ESTABILIDAD DEL PRINCIPIO ACTIVO. EL PROCEDIMIENTO PARA PRODUCIR FORMULACIONES ESTEROIDALES HOMOGENEAS PARA PREPARACIONES FARMACEUTICAS SOLIDAS Y SEMISOLIDAS DE BAJA DOSIS CON UNA CONCENTRACION DE ESTEROIDES DE ENTRE 0,01 Y 1 % EN PESO ES MEJOR ENTRE OTRAS COSAS POR EL HECHO DE QUE EL PRINCIPIO ACTIVO Y LAS PARTICULAS DE ADYUVANTE DE LA SOLUCION ATOMIZADA NO SE SECAN UNO AL LADO DEL OTRO. LA ELECCION DE LAS CONDICIONES DE PROCESADO DURANTE LA ATOMIZACION HACE POSIBLE PARA PRACTICAMENTE TODO EL PRINCIPIO ACTIVO QUE SE UNA INTEGRAMENTE AL ADYUVANTE.
ES97953625T 1996-12-16 1997-12-15 Preformulaciones homogeneas que contienen esteroides en alta concentracion, para la preparacion de composiciones farmaceuticas solidas y semisolidas debilmente dosificadas. Expired - Lifetime ES2179385T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE19652196A DE19652196A1 (de) 1996-12-16 1996-12-16 Homogene steroidhaltige Präformulierungen zur Herstellung niedrigdosierter fester und halbfester pharmazeutischer Zubereitungen

Publications (1)

Publication Number Publication Date
ES2179385T3 true ES2179385T3 (es) 2003-01-16

Family

ID=7814809

Family Applications (1)

Application Number Title Priority Date Filing Date
ES97953625T Expired - Lifetime ES2179385T3 (es) 1996-12-16 1997-12-15 Preformulaciones homogeneas que contienen esteroides en alta concentracion, para la preparacion de composiciones farmaceuticas solidas y semisolidas debilmente dosificadas.

Country Status (13)

Country Link
US (2) US6290931B1 (es)
EP (1) EP0946149B1 (es)
JP (1) JP2001506639A (es)
AT (1) ATE219357T1 (es)
AU (1) AU5748098A (es)
CA (1) CA2275626C (es)
CL (1) CL2004000976A1 (es)
DE (2) DE19652196A1 (es)
DK (1) DK0946149T3 (es)
ES (1) ES2179385T3 (es)
PT (1) PT946149E (es)
RU (1) RU2178694C2 (es)
WO (1) WO1998026762A1 (es)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19906152B4 (de) 1999-02-10 2005-02-10 Jenapharm Gmbh & Co. Kg Wirkstoffhaltige Laminate für Transdermalsysteme
EP1171091A1 (de) * 1999-04-16 2002-01-16 Jenapharm GmbH & Co. KG Pharmazeutische oder kosmetische zusammensetzungen zur lokalen, intradermalen applikation von estrogenen
US6787531B1 (en) * 1999-08-31 2004-09-07 Schering Ag Pharmaceutical composition for use as a contraceptive
EP1216713A1 (en) * 2000-12-20 2002-06-26 Schering Aktiengesellschaft Compositions of estrogen-cyclodextrin complexes
US20050220825A1 (en) * 2004-03-10 2005-10-06 Adrian Funke Molecular dispersions of drospirenone
DE102006026578B4 (de) 2006-06-08 2009-01-08 Lts Lohmann Therapie-Systeme Ag Wirkstoffpartikelhaltiges Transdermales Therapeutisches System mit erhöhtem Wirkstofffluss und Verfahren zu seiner Herstellung sowie Verwendung
DE102008037025C5 (de) 2008-08-08 2016-07-07 Jesalis Pharma Gmbh Verfahren zur Herstellung kristalliner Wirkstoff-Mikropartikel bzw. einer Wirkstoffpartikel-Festkörperform

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4631284A (en) * 1984-11-19 1986-12-23 Mallinckrodt, Inc. Acetaminophen compositions containing low doses of chlorpheniramine maleate, method for preparing same and tablets formed therefrom
IE67345B1 (en) * 1991-03-12 1996-03-20 Akzo Nv Low dose dry pharmaceutical preparations
IT1252867B (it) * 1991-12-31 1995-06-28 Gentili Ist Spa Composizioni farmaceutiche contenenti progesterone ad elevata biodisponibilita'
CA2115065C (en) * 1992-06-12 2000-10-03 Kiyoyuki Sakon Ultrafine particle powder for inhalation and method for production thereof
KR100208979B1 (ko) * 1992-06-12 1999-07-15 야스이 쇼사꾸 기도내 투여용 제제
US5395627A (en) * 1992-09-04 1995-03-07 Akzo N.V. Pharmaceutical granulate
DE4426709A1 (de) * 1994-07-20 1996-01-25 Schering Ag Steroidale Sexualhormone enthaltende feste Arzneiformen

Also Published As

Publication number Publication date
EP0946149B1 (de) 2002-06-19
DE59707573D1 (de) 2002-07-25
DK0946149T3 (da) 2002-10-07
AU5748098A (en) 1998-07-15
EP0946149A1 (de) 1999-10-06
JP2001506639A (ja) 2001-05-22
DE19652196A1 (de) 1998-06-18
CA2275626C (en) 2005-02-15
PT946149E (pt) 2002-11-29
RU2178694C2 (ru) 2002-01-27
ATE219357T1 (de) 2002-07-15
US6290931B1 (en) 2001-09-18
WO1998026762A1 (de) 1998-06-25
US20020119103A1 (en) 2002-08-29
CL2004000976A1 (es) 2005-01-21
CA2275626A1 (en) 1998-06-25

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