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1. (WO2002043750) METHOD FOR THE STABILIZING OF BIOMOLECULES (E.G. INSULIN) IN LIQUID FORMULATIONS
Latest bibliographic data on file with the International Bureau   

Pub. No.: WO/2002/043750 International Application No.: PCT/US2001/048834
Publication Date: 06.06.2002 International Filing Date: 30.11.2001
Chapter 2 Demand Filed: 13.06.2002
IPC:
A61K 38/28 (2006.01) ,A61K 47/10 (2006.01) ,A61K 47/26 (2006.01)
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
28
Insulins
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, inert additives
06
Organic compounds
08
containing oxygen
10
Alcohols; Phenols; Salts thereof
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, inert additives
06
Organic compounds
26
Carbohydrates
Applicants:
BATTELLE MEMORIAL INSTITUTE [US/US]; 505 King Avenue Columbus, OH 43201-2693, US
Inventors:
COWAN, Siu, Man, L.; US
McGINNIS, Vincent; US
PALMER, Donna, T.; US
RISSER, Steven, M.; US
BRODY, Richard, S.; US
Agent:
GOLDSTEIN, Steven, J. ; Frost Brown Todd LLC 2200 PNC Center 201 East Fifth Street Cincinnati, OH 45202, US
Priority Data:
60/250,49101.12.2000US
Title (EN) METHOD FOR THE STABILIZING OF BIOMOLECULES (E.G. INSULIN) IN LIQUID FORMULATIONS
(FR) PROCEDE DE STABILISATION DE BIOMOLECULES DANS DES FORMULATIONS LIQUIDES
Abstract:
(EN) The invention is directed to a stable formulation of a biologically active protein useful for aerosol delivery to the respiratory tract of a patient in need of treatment comprising: (a) a carrier liquid comprising from about 10 % to from about 100 % V/V water and from about 0 % to from about 90 % V/V of an organic liquid; (b) a biologically effective amount of a protein suspended or dissolved in a carrier liquid; and (c) a stabilizing effective amount of a derivatized carbohydrate stabilizing agent suspended or dissolved in said carrier liquid. The stable formulations of the invention may optionally contain about 0.1 % to about 5.0 % W/V of a pharmaceutically acceptable excipient.
(FR) L'invention porte sur une formulation stable d'une protéine biologiquement active utilisée pour être distribuée par aérosol dans les voies respiratoires d'un patient nécessitant un traitement. Cette formulation comprend : (a) un liquide support comprenant entre environ 10 % et environ 100 % v/v d'eau et entre environ 0 % et environ 90 % v/v d'un liquide organique; (b) une quantité efficace d'un point de vue biologique d'une protéine en suspension ou dissoute dans un liquide support ; et (c) une quantité efficace stabilisante d'un agent de stabilisation de glucides dérivatisés, en suspension ou dissous dans le liquide support. Ces formulations stables peuvent éventuellement contenir d'environ 0,1 % à environ 5,0 % m/m d'un excipient acceptable d'un point de vue pharmaceutique.
Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, OM, PH, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW
African Regional Intellectual Property Organization (ARIPO) (GH, GM, KE, LS, MW, MZ, SD, SL, SZ, TZ, UG, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (EPO) (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)