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1. WO2000051629 - PREPARATIONS STABILIZED OVER LONG TIME

Publication Number WO/2000/051629
Publication Date 08.09.2000
International Application No. PCT/JP2000/001160
International Filing Date 29.02.2000
Chapter 2 Demand Filed 29.02.2000
IPC
A61K 38/18 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
18Growth factors; Growth regulators
A61K 38/19 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
19Cytokines; Lymphokines; Interferons
A61K 38/29 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
29Parathyroid hormone (parathormone); Parathyroid hormone-related peptides
A61K 47/18 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16containing nitrogen
18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
CPC
A61K 31/195
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
19Carboxylic acids, e.g. valproic acid
195having an amino group
A61K 31/198
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
19Carboxylic acids, e.g. valproic acid
195having an amino group
197the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
198Alpha-aminoacids, e.g. alanine, edetic acids [EDTA],
A61K 38/1816
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
18Growth factors; Growth regulators
1816Erythropoietin [EPO]
A61K 38/193
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
19Cytokines; Lymphokines; Interferons
193Colony stimulating factors [CSF]
A61K 38/29
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38Medicinal preparations containing peptides
16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17from animals; from humans
22Hormones
29Parathyroid hormone (parathormone); Parathyroid hormone-related peptides
A61K 47/18
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16containing nitrogen, ; e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
Applicants
  • CHUGAI SEIYAKU KABUSHIKI KAISHA [JP]/[JP] (AllExceptUS)
  • SATO, Yasushi [JP]/[JP] (UsOnly)
Inventors
  • SATO, Yasushi
Agents
  • SHAMOTO, Ichio
Priority Data
11/5231401.03.1999JP
Publication Language Japanese (ja)
Filing Language Japanese (JA)
Designated States
Title
(EN) PREPARATIONS STABILIZED OVER LONG TIME
(FR) PREPARATIONS STABILISEES A LONGUE CONSERVATION
Abstract
(EN) Stable G-CSF preparations showing a residual G-CSF ratio of 90 % or more after a long-term storage test at 25 °C for 3 months; showing a residual G-CSF ratio of 90 % or more after a long-term storage test at 40 °C for 2 months; showing a residual G-CSF ratio of 90 % or more after an accelerated test at 50 °C for 1 month; or showing a residual G-CSF ratio of 90 % or more after an accelerated test at 60 °C for 2 weeks; and showing a ratio of the formation of the methionine residue-oxidized derivative of G-CSF of 1 % or less after an accelerated test at 50 °C for 1 month or after an accelerated test at 60 °C for 2 weeks. A method for inhibiting the formation of the methionine residue-oxidized derivative of a physiologically active protein having methionine residues characterized by adding methionine to a composition containing this protein.
(FR) La présente invention concerne des préparations de G-CSF stables présentant un rapport G-CSF résiduel de 90 % ou plus après un test de longue conservation effectué à 25 °C pendant 3 mois; présentant un rapport G-CSF de 90 % ou plus après un test de courte conservation effectué à 40 °C pendant 2 mois; présentant un rapport G-CSF résiduel de 90 % ou plus après un test accéléré effectué à 50 °C ou plus pendant 1 mois; ou présentant un rapport G-CSF résiduel de 90 % ou plus après un test accéléré effectué à 60 °C ou plus pendant 2 semaines; et présentant un rapport de formation du dérivé de méthionine à résidu oxydé de G-CSF de 1 % ou moins après un test accéléré effectué à 50 °C pendant un mois, ou après un test accéléré effectué à 60 °C pendant 2 semaines. En outre, cette invention concerne un procédé inhibant la formation du dérivé de méthionine à résidu oxydé d'une protéine active sur le plan physiologique présentant des résidus de méthionine, caractérisé par l'addition de méthionine dans une composition renfermant cette protéine.
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