ES2142409T3 - Prostaglandina e 1 estabilizada. - Google Patents

Prostaglandina e 1 estabilizada.

Info

Publication number
ES2142409T3
ES2142409T3 ES94927958T ES94927958T ES2142409T3 ES 2142409 T3 ES2142409 T3 ES 2142409T3 ES 94927958 T ES94927958 T ES 94927958T ES 94927958 T ES94927958 T ES 94927958T ES 2142409 T3 ES2142409 T3 ES 2142409T3
Authority
ES
Spain
Prior art keywords
formulation
lactose
pct
pge
tertiary butyl
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
ES94927958T
Other languages
English (en)
Inventor
Dirk L Teagarden
William J Petre
Paul M Gold
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 and Upjohn Co
Original Assignee
Pharmacia and Upjohn Co
Upjohn Co
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 and Upjohn Co, Upjohn Co filed Critical Pharmacia and Upjohn Co
Application granted granted Critical
Publication of ES2142409T3 publication Critical patent/ES2142409T3/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
    • A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

SE PRESENTA UNA FORMULACION ESTABLE Y LIOFILIZADA DE PROSTAGLANDINA E{SUB,1} HECHA MEDIANTE UN PROCEDIMIENTO QUE COMPRENDE A) LA DISOLUCION DE LA PGE-1 EN UNA SOLUCION DE LACTOSA Y ALCOHOL DE BUTILO TERCIARIO EN DONDE EL ALCOHOL DE BUTILO TERCIARIO ESTA PRESENTE EN UNA CANTIDAD DE ENTRE EL 15% Y EL 33% DE VOLUMEN/VOLUMEN Y LA PROPORCION DE LA LACTOSA CON RESPECTO A LA PGE-1 ES DE ENTRE 40000 A 1 Y 10000 A 1 DEL PESO/PESO MEDIANTE LO CUAL SE FORMA UNA FORMULACION DE PGE-1 DISPERSA EN LACTOSA; B) EL AJUSTE Y EL MANTENIMIENTO DEL PH DE LA FORMULACION ENTRE 3.5 Y 6 CON UN NEUTRALIZADOR DE ACIDO ORGANICO; C) LA CONGELACION DE LA FORMULACION HASTA ALREDEDOR DE -50 (GRADOS) C; D) EL SECADO DE LA FORMULACION PARA OBTENER UN CONTENIDO DE HUMEDAD INFERIOR AL 1% DE SU PESO EN SECO Y UN CONTENIDO DE ALCOHOL DE BUTILO TERCIARIO INFERIOR AL 3% DE SU PESO EN SECO. PREFERIBLEMENTE EL PASO C) INCLUYE DESPUES DE LA CONGELACION DE LA FORMULACION HASTA ALREDEDOR DE -50 (GRADOS) C, EL CALENTAMIENTO HASTA ALREDEDOR DE -25 (GRADOS) C DURANTE ALREDEDOR DE DOS HORAS Y LUEGO SE VUELVE A CONGELAR A 50 (GRADOS) C. PREFERIBLEMENTE, LA PROSTAGLANDINA ESTA EN UNA CANTIDAD DE ALREDEDOR DE ENTRE 25 Y 100 PPM EN LACTOSA Y EL PH SE MANTIENE ENTRE 4 Y 5.
ES94927958T 1993-10-27 1994-09-06 Prostaglandina e 1 estabilizada. Expired - Lifetime ES2142409T3 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US14369593A 1993-10-27 1993-10-27

Publications (1)

Publication Number Publication Date
ES2142409T3 true ES2142409T3 (es) 2000-04-16

Family

ID=22505188

Family Applications (1)

Application Number Title Priority Date Filing Date
ES94927958T Expired - Lifetime ES2142409T3 (es) 1993-10-27 1994-09-06 Prostaglandina e 1 estabilizada.

Country Status (16)

Country Link
US (2) US5741523A (es)
EP (1) EP0725642B1 (es)
JP (1) JP3999263B2 (es)
KR (1) KR100335549B1 (es)
CN (1) CN1060042C (es)
AT (1) ATE187071T1 (es)
AU (1) AU688792B2 (es)
DE (1) DE69421936T2 (es)
DK (1) DK0725642T3 (es)
ES (1) ES2142409T3 (es)
FI (1) FI116270B (es)
GR (1) GR3032817T3 (es)
NO (1) NO309126B1 (es)
NZ (1) NZ273752A (es)
PT (1) PT725642E (es)
WO (1) WO1995011683A1 (es)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6143746A (en) * 1994-01-21 2000-11-07 Icos Corporation Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use
KR100195348B1 (ko) * 1996-10-31 1999-06-15 장용택 안정한 프로스타글란딘 e1-함유 주사제 조성물
JP2001509480A (ja) 1997-07-09 2001-07-24 アンドロソリューションズ，インク． 男性勃起機能不全を治療するための改良された方法及び組成物
US6103765A (en) 1997-07-09 2000-08-15 Androsolutions, Inc. Methods for treating male erectile dysfunction
TR200002543T2 (tr) * 1998-03-03 2000-11-21 Shionogi & Co., Ltd. Fosfolipaz önleyici sodyum [[3-(2-amino-1,2-dioksietil-1-fenilmetil) -2-etil-1-fenilmetil)- 1H-indol-4-il]oksi] asetat içeren farmasötik kompozisyonlar
US6486207B2 (en) 1998-12-10 2002-11-26 Nexmed (Holdings), Inc. Compositions and methods for amelioration of human female sexual dysfunction
US6825234B2 (en) 1998-12-10 2004-11-30 Nexmed (Holdings) , Inc. Compositions and methods for amelioration of human female sexual dysfunction
US6264981B1 (en) † 1999-10-27 2001-07-24 Anesta Corporation Oral transmucosal drug dosage using solid solution
IL163666A0 (en) 2002-02-22 2005-12-18 New River Pharmaceuticals Inc Active agent delivery systems and methods for protecting and administering active agents
CA2543296A1 (en) * 2003-10-31 2005-05-12 Point Biomedical Corporation Reconstitutable microsphere compositions useful as ultrasonic contrast agents
EP1814544A4 (en) * 2004-11-05 2009-12-02 Cephalon Inc CANCER TREATMENTS
US7582312B2 (en) 2004-11-15 2009-09-01 Discovery Laboratories, Inc. Methods to produce lung surfactant formulations via lyophilization and formulations and uses thereof
US7464012B2 (en) * 2004-12-10 2008-12-09 L'air Liquide, Societe Anonyme A Directoire Et Conseil De Surveillance Pour L'etude Et L'exploitation Des Procedes Georges Claude Simplified process simulator
JPWO2006075690A1 (ja) * 2005-01-14 2008-06-12 小野薬品工業株式会社 安定な医薬組成物
US8436190B2 (en) 2005-01-14 2013-05-07 Cephalon, Inc. Bendamustine pharmaceutical compositions
US9005183B2 (en) * 2007-05-16 2015-04-14 Health Knight, Llc System and method for treating erectile dysfunction
US20100222785A1 (en) * 2007-08-03 2010-09-02 Vanderbilt University Anchor driver
AR072777A1 (es) 2008-03-26 2010-09-22 Cephalon Inc Formas solidas de clorhidrato de bendamustina
EP2889029A1 (en) * 2008-09-25 2015-07-01 Cephalon, Inc. Liquid formulations of bendamustine
KR20110110293A (ko) * 2009-01-15 2011-10-06 세파론, 인코포레이티드 벤다무스틴 유리 염기의 신규 형태
PT3158991T (pt) 2010-01-28 2021-06-23 Eagle Pharmaceuticals Inc Formulações de bendamustina
US10342769B2 (en) 2014-11-14 2019-07-09 Navinta Iii Inc Carmustine pharmaceutical composition
AT518009A1 (de) * 2015-07-27 2017-06-15 Gebro Holding Gmbh Konzentrat enthaltend Alprostadil
CN109394704B (zh) * 2018-11-27 2021-09-17 西安力邦肇新生物科技有限公司 一种前列腺素e1甲酯注射用冻干制剂及制备和应用

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3927197A (en) * 1974-04-19 1975-12-16 Pfizer Tertiary alcohol stabilized E-series prostaglandins
US3952004A (en) * 1974-06-18 1976-04-20 Pfizer Inc. Stabilized E-series prostaglandins
US4113882A (en) * 1974-10-21 1978-09-12 Yamanouchi Pharmaceutical Co., Ltd. Stabilized oral prostaglandin formulation and the process for the preparation thereof
AU617678B2 (en) * 1987-05-22 1991-12-05 Liposome Company, Inc., The Prostaglandin-lipid formulations

Also Published As

Publication number Publication date
AU7716794A (en) 1995-05-22
NO309126B1 (no) 2000-12-18
ATE187071T1 (de) 1999-12-15
CN1060042C (zh) 2001-01-03
KR100335549B1 (ko) 2002-11-29
US5770230A (en) 1998-06-23
WO1995011683A1 (en) 1995-05-04
US5741523A (en) 1998-04-21
DK0725642T3 (da) 2000-05-29
NO961718D0 (no) 1996-04-29
JP3999263B2 (ja) 2007-10-31
FI116270B (fi) 2005-10-31
CN1133561A (zh) 1996-10-16
FI961797A (fi) 1996-04-26
EP0725642B1 (en) 1999-12-01
DE69421936D1 (de) 2000-01-05
FI961797A0 (fi) 1996-04-26
PT725642E (pt) 2000-05-31
NO961718L (no) 1996-04-29
AU688792B2 (en) 1998-03-19
EP0725642A1 (en) 1996-08-14
KR960705572A (ko) 1996-11-08
JPH09504529A (ja) 1997-05-06
DE69421936T2 (de) 2000-06-29
NZ273752A (en) 1998-03-25
GR3032817T3 (en) 2000-06-30

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