WO1995022342A1 - Formulations pharmaceutiques du facteur neurotrophe ciliaire - Google Patents

Formulations pharmaceutiques du facteur neurotrophe ciliaire Download PDF

Info

Publication number
WO1995022342A1
WO1995022342A1 PCT/US1995/002194 US9502194W WO9522342A1 WO 1995022342 A1 WO1995022342 A1 WO 1995022342A1 US 9502194 W US9502194 W US 9502194W WO 9522342 A1 WO9522342 A1 WO 9522342A1
Authority
WO
WIPO (PCT)
Prior art keywords
formulation
cntf
neurotrophic factor
ciliary neurotrophic
thiol
Prior art date
Application number
PCT/US1995/002194
Other languages
English (en)
Inventor
Victoria Knepp
Thomas Calderwood
Leo Gu
John Whatley
Anna Muchnik
Original Assignee
The Syntex-Synergen Neuroscience Joint Venture
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 The Syntex-Synergen Neuroscience Joint Venture filed Critical The Syntex-Synergen Neuroscience Joint Venture
Priority to AU19265/95A priority Critical patent/AU1926595A/en
Publication of WO1995022342A1 publication Critical patent/WO1995022342A1/fr

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/107—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
    • C07K1/113—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure
    • C07K1/1133—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure by redox-reactions involving cystein/cystin side chains
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/185—Nerve growth factor [NGF]; Brain derived neurotrophic factor [BDNF]; Ciliary neurotrophic factor [CNTF]; Glial derived neurotrophic factor [GDNF]; Neurotrophins, e.g. NT-3

Definitions

  • This invention provides formulations of CNTF which are stable to lyophilization and reconstitution, and methods of storing biologically active CNTF.
  • the bulking agent generally provides mechanical support by allowing the matrix to maintain its conformation during and after the freeze drying process.
  • One or more sugars may be used as the bulking agent.
  • Sugars include but are not limited to, monosaccharides, oligosaccharides and polysaccharides, provided that the sugar remains amorphous during the freezing cycle. Examples of suitable sugars include fructose, glucose, mannose, ribose, xylose, maltose, lactose, sucrose, and dextran.
  • Sugar also includes sugar alcohols, such as sorbitol, inositol, dulcitol, xylitol, and arabitol . Mixtures of sugars may also be used in accordance with this invention.
  • the most preferred bulking agent of the present invention is sucrose.
  • the gradient profile (A:B) ranged from 100:0 to 0:100 (20 mins.) to 100:0 (25 min.) .

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Psychology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

On décrit des formulations aqueuses du facteur neurotrophe ciliaire (F.N.C.) se prêtant à la lyophilisation puis à une reconstitution ultérieure, telles que le FNC humain recombiné est mélangé avec un diluant et un antioxydant contenant un thiol.
PCT/US1995/002194 1994-02-22 1995-02-21 Formulations pharmaceutiques du facteur neurotrophe ciliaire WO1995022342A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU19265/95A AU1926595A (en) 1994-02-22 1995-02-21 Pharmaceutical formulations of ciliary neurotrophic factor

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US19977194A 1994-02-22 1994-02-22
US08/199,771 1994-02-22

Publications (1)

Publication Number Publication Date
WO1995022342A1 true WO1995022342A1 (fr) 1995-08-24

Family

ID=22738959

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1995/002194 WO1995022342A1 (fr) 1994-02-22 1995-02-21 Formulations pharmaceutiques du facteur neurotrophe ciliaire

Country Status (2)

Country Link
AU (1) AU1926595A (fr)
WO (1) WO1995022342A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6313089B1 (en) 1997-08-20 2001-11-06 Duke University Complexes of apolipoprotein E and ciliary neurotrophic factor (CNTF) and methods of use
EP1592429A1 (fr) * 2003-01-20 2005-11-09 Neurotech Pharmaceuticals Co., Ltd. Methode d'inhibition de necrose induite par la neurotrophine
US8686185B2 (en) 2007-11-12 2014-04-01 Neurotech Pharmaceuticals Co., Ltd. Manufacturing method of 2-hydroxy-5-phenylalkylaminobenzoic acid derivatives and their salts

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5011914A (en) * 1989-01-05 1991-04-30 Collins Franklin D Purified ciliary neurotrophic factor
US5218094A (en) * 1986-08-07 1993-06-08 Fidia, S.P.A. Neuronotrophic factor derived from mammalian brain tissue

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5218094A (en) * 1986-08-07 1993-06-08 Fidia, S.P.A. Neuronotrophic factor derived from mammalian brain tissue
US5011914A (en) * 1989-01-05 1991-04-30 Collins Franklin D Purified ciliary neurotrophic factor

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PROC. NATL. ACAD. SCI. U.S.A., Volume, 91, issued August 1994, MAYER et al., "N-Acetyl-L-Cysteine is a Pluripotent Protector Against Cell Death and Enhancer of Trophic Factor-Mediated Cell Survival in Vitro", pages 7496-7500. *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6313089B1 (en) 1997-08-20 2001-11-06 Duke University Complexes of apolipoprotein E and ciliary neurotrophic factor (CNTF) and methods of use
EP1592429A1 (fr) * 2003-01-20 2005-11-09 Neurotech Pharmaceuticals Co., Ltd. Methode d'inhibition de necrose induite par la neurotrophine
EP1592429A4 (fr) * 2003-01-20 2007-01-10 Neurotech Pharmaceuticals Co L Methode d'inhibition de necrose induite par la neurotrophine
US7608585B2 (en) 2003-01-20 2009-10-27 Neurotech Pharmaceuticals Co., Ltd. Compositions for inhibition of necrosis induced by a neurotrophin
US8686185B2 (en) 2007-11-12 2014-04-01 Neurotech Pharmaceuticals Co., Ltd. Manufacturing method of 2-hydroxy-5-phenylalkylaminobenzoic acid derivatives and their salts

Also Published As

Publication number Publication date
AU1926595A (en) 1995-09-04

Similar Documents

Publication Publication Date Title
US20230047111A1 (en) Pharmaceutical formulations of tnf-alpha antibodies
EP0721343B1 (fr) Preparation pharmaceutique du facteur de croissance nerveuse
EP2289539B1 (fr) Préparations d'insuline sans zinc ou pauvre en zinc dotées d'une stabilité améliorée
JP3031570B2 (ja) 安定化されたゴナドトロピンを含有する調製品
CA2139358C (fr) Formule aqueuse d'hormone de croissance humaine
DE69532970T3 (de) Sprühgetrocknetes erythropoietin
US5981485A (en) Human growth hormone aqueous formulation
US5763394A (en) Human growth hormone aqueous formulation
DE60009529T2 (de) Pharmazeutische zusammensetzung aus fibrinolytischem mittel
WO1995022560A1 (fr) Formulations pharmaceutiques comprenant un facteur neurotrophique ciliaire
US5384132A (en) Stabilized gonadotropin containing preparations
WO1995022342A1 (fr) Formulations pharmaceutiques du facteur neurotrophe ciliaire
US5270057A (en) Stabilized gonadotropin containing preparations
EP1435914B1 (fr) Preparation pharmaceutique lyophilisee galenique stable de polypeptides de recombinaison liant les hydrocarbures
AU778208C (en) GRF-containing lyophilized pharmaceutical compositions
WO1997007816A1 (fr) Solution contenant l'igf-i

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AM AT AU BB BG BR BY CA CH CN CZ DE DK EE ES FI GB GE HU JP KE KG KP KR KZ LK LR LT LU LV MD MG MN MW MX NL NO NZ PL PT RO RU SD SE SI SK TJ TT UA UZ VN

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): KE MW SD SZ UG AT BE CH DE DK ES FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: CA