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Machine translation
1. (WO2006081320) PHARMACEUTICAL FORMULATION
Latest bibliographic data on file with the International Bureau   

Pub. No.:    WO/2006/081320    International Application No.:    PCT/US2006/002696
Publication Date: 03.08.2006 International Filing Date: 26.01.2006
IPC:
A61K 39/395 (2006.01), C07K 16/00 (2006.01), C12P 21/08 (2006.01)
Applicants: HUMAN GENOME SCIENCES, INC. [US/US]; 14200 Shady Grove Road, Rockville, MD 20850 (US) (For All Designated States Except US).
COLANDENE, James D. [US/US]; (US) (For US Only).
SPITZNAGEL, Thomas M. [US/US]; (US) (For US Only).
CREAGH, Alma [US/US]; (US) (For US Only).
VRETTOS, John S. [US/US]; (US) (For US Only).
MALDONADO, Linda M. [US/US]; (US) (For US Only).
PERKINS, Melissa D. [US/US]; (US) (For US Only).
GRILLO, Adeola O. [NG/US]; (US) (For US Only)
Inventors: COLANDENE, James D.; (US).
SPITZNAGEL, Thomas M.; (US).
CREAGH, Alma; (US).
VRETTOS, John S.; (US).
MALDONADO, Linda M.; (US).
PERKINS, Melissa D.; (US).
GRILLO, Adeola O.; (US)
Agent: PYTEL, Melissa J.; Human Genome Sciences, Inc., 14200 Shady Grove Road, Rockville, MD 20850 (US)
Priority Data:
60/647,011 27.01.2005 US
Title (EN) PHARMACEUTICAL FORMULATION
(FR) PREPARATION PHARMACEUTIQUE
Abstract: front page image
(EN)Lyophilization processes for a pharmaceutical formulation are provided in which the temperature of the product during the primary drying stage is above the glass transition temperature (Tg') of the formulation or above the glass transition temperature (Tg') and the collapse onset temperature (TO), but below the collapse temperature (Tc). A pharmaceutical formulation that includes a protein concentration of at least about 20 mg/mL is also provided. Additionally, a pharmaceutical formulation that includes little or no crystalline bulking agent and/or at least about 2% w/v disaccharide.
(FR)L'invention porte sur des procédés de lyophilisation de préparations pharmaceutiques selon lesquels pendant la première étape de dessiccation la température du produit doit être supérieure à sa température de transition vitreuse (Tg') ou supérieure à sa température de transition vitreuse (Tg') et à la température de début d'effondrement (TO), mais inférieure à la température d'effondrement (Tc). L'invention porte également sur une préparation pharmaceutique présentant une concentration en protéines d'au moins environ 20 mg/ml, et sur une préparation pharmaceutique contenant peu ou pas d'agent gonflant cristallin et/ou au moins environ 2 % w/v de disaccharide.
Designated States: AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RU, SC, SD, SE, SG, SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, YU, ZA, ZM, ZW.
African Regional Intellectual Property Organization (BW, GH, GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Organization (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM)
European Patent Office (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, LV, MC, NL, PL, PT, RO, SE, SI, SK, 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)