FI111221B - Förfarande för framställning av farmaceutiska granulater - Google Patents

Förfarande för framställning av farmaceutiska granulater Download PDF

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Publication number
FI111221B
FI111221B FI935584A FI935584A FI111221B FI 111221 B FI111221 B FI 111221B FI 935584 A FI935584 A FI 935584A FI 935584 A FI935584 A FI 935584A FI 111221 B FI111221 B FI 111221B
Authority
FI
Finland
Prior art keywords
granules
carrier
steroid
desogestrel
mixture
Prior art date
Application number
FI935584A
Other languages
English (en)
Finnish (fi)
Other versions
FI935584A0 (fi
FI935584A (sv
Inventor
Jan Hendrik Dopper
Der Ven Cornelis Josephus Van
Original Assignee
Akzo Nv
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27578967&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=FI111221(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to US07/941,026 priority Critical patent/US5395627A/en
Priority to DK93203476T priority patent/DK0657161T3/da
Priority to ES93203476T priority patent/ES2125300T3/es
Priority to EP93203476A priority patent/EP0657161B1/en
Priority to DE69322396T priority patent/DE69322396T2/de
Priority to AT93203476T priority patent/ATE173918T1/de
Priority to FI935584A priority patent/FI111221B/sv
Publication of FI935584A0 publication Critical patent/FI935584A0/fi
Priority to NZ250443A priority patent/NZ250443A/en
Application filed by Akzo Nv filed Critical Akzo Nv
Priority to ZA939337A priority patent/ZA939337B/xx
Priority to CA002111320A priority patent/CA2111320A1/en
Priority to NO934584A priority patent/NO306928B1/no
Priority to AU52391/93A priority patent/AU672447B2/en
Priority to JP32229093A priority patent/JP3720385B2/ja
Priority to CN93121510A priority patent/CN1050043C/zh
Priority to US08/366,348 priority patent/US5527543A/en
Publication of FI935584A publication Critical patent/FI935584A/sv
Priority to GR990400353T priority patent/GR3029273T3/el
Publication of FI111221B publication Critical patent/FI111221B/sv
Application granted granted Critical

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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
    • A61K9/167—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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Steroid Compounds (AREA)

Claims (8)

1. Förfarande för framställning av granulater som är steroidbelastade, kännetecknat av att 5 a) en steroid och ett smörjmedel upplöses i en tillräcklig mängd av ett organiskt lösningsmedel för att bilda en lösning; b) lösningen blandas med en bärare, som innehaller utspädningsmedel och bindemedel, varvid en blandning av 10 lösningen och bäraren bildas; och c) det organiska lösningsmedlet avlägsnas frän blandningen samtidigt som blandningen blandas för att bilda granulater som är steroidbelastade.
2. Förfarande enligt patentkrav 1, känne-15 tecknat av att nämnda organiska lösningsmedel avlägsnas i en vakuumblandare.
3. Förfarande enligt patentkrav 1 eller 2, kännetecknat av att nämnda steroid är desogestrel.
4. Förfarande enligt vilket som heist av 20 patentkraven 1 - 3, kännetecknat av att nämnda smörjmedel är stearinsyra.
5. Förfarande enligt patentkrav 1 för fram-ställning av en granulat som lämpar sig för framställning !1. av en farmaceutisk doseringsenhet, kännetecknat av 25 att granulatet innehaller en filmbeläggning, som innehaller en steroid och ett smörjmedel.
6. Förfarande enligt patentkrav 5, kännetecknat av att granulaten innehaller desogestrel och stearinsyra och att den kvarhäller 90 % av desogestrelen, 30 när den förvaras 72 timmar vid ett tryck pä 150 mbar och vid en temperatur pä 70 °C.
7. Förfarande enligt patentkrav 5 eller 6, kännetecknat av att granulaten omfattar a) en bärare som innehaller laktos, polyvinylpyr-35 rolidon och dispersionsmedel; och 16 111221 b) nämnda bärare har en filmbeläggning, vilken film innehäller desogestrel och stearinsyra.
8. Förfarande enligt vilket som heist av patent-kraven 5 - 7, kännetecknat av att granulaten bringas 5 tili formen av en tablett. > «
FI935584A 1992-09-04 1993-12-13 Förfarande för framställning av farmaceutiska granulater FI111221B (sv)

Priority Applications (16)

Application Number Priority Date Filing Date Title
US07/941,026 US5395627A (en) 1992-09-04 1992-09-04 Pharmaceutical granulate
ES93203476T ES2125300T3 (es) 1992-09-04 1993-12-10 Granulados farmaceuticos que contienen esteroides.
EP93203476A EP0657161B1 (en) 1992-09-04 1993-12-10 Pharmaceutical granulate containing steroids
DE69322396T DE69322396T2 (de) 1992-09-04 1993-12-10 Steroide enthaltende pharmazeutische Granulate
AT93203476T ATE173918T1 (de) 1992-09-04 1993-12-10 Steroide enthaltende pharmazeutische granulate
DK93203476T DK0657161T3 (da) 1992-09-04 1993-12-10 Farmaceutisk granulat indeholdende steroider
NO934584A NO306928B1 (no) 1992-09-04 1993-12-13 Fremgangsmåte for fremstilling av steroidholdige granuler, samt granuler og tablett
NZ250443A NZ250443A (en) 1992-09-04 1993-12-13 Preparation of film coated, steroid-loaded granules
FI935584A FI111221B (sv) 1992-09-04 1993-12-13 Förfarande för framställning av farmaceutiska granulater
ZA939337A ZA939337B (en) 1992-09-04 1993-12-13 Pharmaceutical granulate
CA002111320A CA2111320A1 (en) 1992-09-04 1993-12-13 Pharmaceutical granulate
AU52391/93A AU672447B2 (en) 1992-09-04 1993-12-14 Pharmaceutical granulate
JP32229093A JP3720385B2 (ja) 1992-09-04 1993-12-21 医薬顆粒
CN93121510A CN1050043C (zh) 1992-09-04 1993-12-29 药物颗粒
US08/366,348 US5527543A (en) 1992-09-04 1994-12-29 Pharmaceutical granulate
GR990400353T GR3029273T3 (en) 1992-09-04 1999-02-03 Pharmaceutical granulate containing steroids.

Applications Claiming Priority (20)

Application Number Priority Date Filing Date Title
US07/941,026 US5395627A (en) 1992-09-04 1992-09-04 Pharmaceutical granulate
US94102692 1992-09-04
EP93203476A EP0657161B1 (en) 1992-09-04 1993-12-10 Pharmaceutical granulate containing steroids
EP93203476 1993-12-10
NZ250443A NZ250443A (en) 1992-09-04 1993-12-13 Preparation of film coated, steroid-loaded granules
ZA9309337 1993-12-13
NZ25044393 1993-12-13
NO934584 1993-12-13
ZA939337A ZA939337B (en) 1992-09-04 1993-12-13 Pharmaceutical granulate
CA2111320 1993-12-13
CA002111320A CA2111320A1 (en) 1992-09-04 1993-12-13 Pharmaceutical granulate
FI935584 1993-12-13
FI935584A FI111221B (sv) 1992-09-04 1993-12-13 Förfarande för framställning av farmaceutiska granulater
NO934584A NO306928B1 (no) 1992-09-04 1993-12-13 Fremgangsmåte for fremstilling av steroidholdige granuler, samt granuler og tablett
AU52391/93A AU672447B2 (en) 1992-09-04 1993-12-14 Pharmaceutical granulate
AU5239193 1993-12-14
JP32229093 1993-12-21
JP32229093A JP3720385B2 (ja) 1992-09-04 1993-12-21 医薬顆粒
CN93121510 1993-12-29
CN93121510A CN1050043C (zh) 1992-09-04 1993-12-29 药物颗粒

Publications (3)

Publication Number Publication Date
FI935584A0 FI935584A0 (fi) 1993-12-13
FI935584A FI935584A (sv) 1995-06-14
FI111221B true FI111221B (sv) 2003-06-30

Family

ID=27578967

Family Applications (1)

Application Number Title Priority Date Filing Date
FI935584A FI111221B (sv) 1992-09-04 1993-12-13 Förfarande för framställning av farmaceutiska granulater

Country Status (15)

Country Link
US (2) US5395627A (sv)
EP (1) EP0657161B1 (sv)
JP (1) JP3720385B2 (sv)
CN (1) CN1050043C (sv)
AT (1) ATE173918T1 (sv)
AU (1) AU672447B2 (sv)
CA (1) CA2111320A1 (sv)
DE (1) DE69322396T2 (sv)
DK (1) DK0657161T3 (sv)
ES (1) ES2125300T3 (sv)
FI (1) FI111221B (sv)
GR (1) GR3029273T3 (sv)
NO (1) NO306928B1 (sv)
NZ (1) NZ250443A (sv)
ZA (1) ZA939337B (sv)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5976570A (en) * 1993-12-21 1999-11-02 Applied Analytical Industries, Inc. Method for preparing low dose pharmaceutical products
US6077533A (en) * 1994-05-25 2000-06-20 Purdue Pharma L.P. Powder-layered oral dosage forms
IL113816A (en) * 1994-06-08 1998-12-06 Akzo Nobel Nv Pharmaceutical preparations containing desogestral, their preparation and use
US5994348A (en) * 1995-06-07 1999-11-30 Sanofi Pharmaceutical compositions containing irbesartan
CA2224269C (en) * 1995-06-22 2008-06-17 Akzo Nobel N.V. Compressed dry-granulation desogestrel tablets
WO1997004752A1 (en) * 1995-07-26 1997-02-13 Duramed Pharmaceuticals, Inc. Pharmaceutical compositions of conjugated estrogens and methods for their use
US6348216B1 (en) * 1996-06-10 2002-02-19 Knoll Pharmaceutical Company Ibuprofen and narcotic analgesic compositions
US6361794B1 (en) 1996-06-12 2002-03-26 Basf Corporation Method of making ibuprofen and narcotic analgesic composition
GB9613470D0 (en) * 1996-06-27 1996-08-28 Ciba Geigy Ag Small solid oral dosage form
DE19652196A1 (de) * 1996-12-16 1998-06-18 Jenapharm Gmbh Homogene steroidhaltige Präformulierungen zur Herstellung niedrigdosierter fester und halbfester pharmazeutischer Zubereitungen
ATE195871T1 (de) 1997-09-23 2000-09-15 Akzo Nobel Nv Steroid enthaltende dosierungsformen mit einer steroiddichten umhüllung
ATE246703T1 (de) * 1999-04-06 2003-08-15 Akzo Nobel Nv Oral wirksame 7-alpha-alkyl androgene
CA2431521E (en) * 2000-12-14 2013-04-16 Ortho-Mcneil Pharmaceutical, Inc. Steroid hormone products and methods for preparing them
US6630166B1 (en) 2001-02-12 2003-10-07 Watson Pharmaceuticals, Inc. Compositions for conjugated estrogens and associated methods
US7303763B2 (en) * 2001-02-12 2007-12-04 Watson Laboratories, Inc. Compositions for conjugated estrogens and associated methods
EP1275377B1 (en) * 2001-07-11 2003-06-18 Apr Applied Pharma Research S.A. Granulates containing liposoluble substances and process of preparation thereof
TW200403075A (en) * 2002-05-29 2004-03-01 Akzo Nobel Nv Progestagenic dosage units
JP4756153B2 (ja) * 2004-08-27 2011-08-24 富士製薬工業株式会社 低成分含量の錠剤の製造方法
EP1853272A1 (en) * 2005-02-03 2007-11-14 Duramed Pharmaceuticals, Inc. Compositions of unconjugated estrogens and methods for their use
US20070248665A1 (en) * 2006-04-24 2007-10-25 Sherman Bernard C Compositions comprising co-precipitate of eplerenone and a water-soluble excipient
US10952968B2 (en) * 2012-05-14 2021-03-23 Shionogi & Co., Ltd. Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives
EP2919903B1 (en) 2012-11-14 2020-07-22 W.R. Grace & CO. - CONN. Compositions containing a biologically active material and a non-ordered inorganic oxide
CN103271928A (zh) * 2013-05-31 2013-09-04 南通联亚药业有限公司 一种改进去氧孕烯稳定性的处方工艺
CN103271927A (zh) * 2013-05-31 2013-09-04 南通联亚药业有限公司 一种改进口服避孕药含量均匀性三级稀释法的工艺

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Also Published As

Publication number Publication date
AU672447B2 (en) 1996-10-03
JPH07196513A (ja) 1995-08-01
GR3029273T3 (en) 1999-05-28
US5527543A (en) 1996-06-18
NO934584L (no) 1995-06-14
EP0657161A1 (en) 1995-06-14
FI935584A0 (fi) 1993-12-13
DK0657161T3 (da) 1999-08-16
NO306928B1 (no) 2000-01-17
NO934584D0 (no) 1993-12-13
DE69322396T2 (de) 1999-07-29
AU5239193A (en) 1995-07-13
JP3720385B2 (ja) 2005-11-24
US5395627A (en) 1995-03-07
ES2125300T3 (es) 1999-03-01
ZA939337B (en) 1994-10-13
EP0657161B1 (en) 1998-12-02
CN1050043C (zh) 2000-03-08
ATE173918T1 (de) 1998-12-15
FI935584A (sv) 1995-06-14
DE69322396D1 (de) 1999-01-14
NZ250443A (en) 1995-07-26
CN1104487A (zh) 1995-07-05
CA2111320A1 (en) 1995-06-14

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