WO2000051629 PREPARATIONS STABILIZED OVER LONG TIME

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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

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Applicants

CHUGAI SEIYAKU KABUSHIKI KAISHA [JP]/[JP] (AllExceptUS)
SATO, Yasushi [JP]/[JP] (UsOnly)

Inventors

SATO, Yasushi

Agents

SHAMOTO, Ichio

Priority Data

11/52314

01.03.1999

Publication Language Japanese (ja)

Filing Language Japanese (JA)

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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.

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38	Medicinal preparations containing peptides
16	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17	from animals; from humans
18	Growth factors; Growth regulators

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38	Medicinal preparations containing peptides
16	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17	from animals; from humans
19	Cytokines; Lymphokines; Interferons

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38	Medicinal preparations containing peptides
16	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17	from animals; from humans
22	Hormones
29	Parathyroid hormone (parathormone); Parathyroid hormone-related peptides

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47	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
06	Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
16	containing nitrogen
18	Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38	Medicinal preparations containing peptides
16	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
17	from animals; from humans
18	Growth factors; Growth regulators

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1. WO2000051629 - PREPARATIONS STABILIZED OVER LONG TIME

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
P	SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
37	Drugs for immunological or allergic disorders
02	Immunomodulators
04	Immunostimulants

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
185	Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
19	Carboxylic acids, e.g. valproic acid
195	having an amino group
197	the 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
198	Alpha-aminoacids, e.g. alanine, edetic acids [EDTA],

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
185	Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic, hydroximic acids
19	Carboxylic acids, e.g. valproic acid
195	having an amino group
197	the 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
198	Alpha-aminoacids, e.g. alanine, edetic acids [EDTA],

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
0012	Galenical forms characterised by the site of application
0019	Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
14	Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
19	lyophilised ; , i.e. freeze-dried, solutions or dispersions