PHARMACEUTICAL FORMULATION

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PHARMACEUTICAL FORMULATION
Publication Number: WO/2006/081320 International Application No.: PCT/US2006/002696
Publication Date: 03.08.2006 International Filing Date: 26.01.2006

Int. Class.: 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) (All Except US).
COLANDENE, James D. [US/US]; 9542 Oakhurst Drive, Columbia, MD 21046 (US) (US Only).
SPITZNAGEL, Thomas M. [US/US]; 8414 Stonewall Drive, Vienna, VA 22180 (US) (US Only).
CREAGH, Alma [US/US]; 8498 Hayshed Lane, Columbia, MD 21045 (US) (US Only).
VRETTOS, John S.[US/US]; 11318 Windsor Road, Ijamsville, MD 21754 (US) (US Only).
MALDONADO, Linda M. [US/US]; 239 Autumn Chase Drive, Annapolis, MD 21401 (US) (US Only).
PERKINS, Melissa D. [US/US]; 18809 Porterfield Way, Germantown, MD 20874 (US) (US Only).
GRILLO, Adeola O. [NG/US]; 13819 Crosstie Drive, Germantown, MD 20874 (US) (US Only).
Inventors: COLANDENE, James D. [US/US]; 9542 Oakhurst Drive, Columbia, MD 21046 (US).
SPITZNAGEL, Thomas M. [US/US]; 8414 Stonewall Drive, Vienna, VA 22180 (US).
CREAGH, Alma [US/US]; 8498 Hayshed Lane, Columbia, MD 21045 (US).
VRETTOS, John S. [US/US]; 11318 Windsor Road, Ijamsville, MD 21754 (US).
MALDONADO, Linda M. [US/US]; 239 Autumn Chase Drive, Annapolis, MD 21401 (US).
PERKINS, Melissa D. [US/US]; 18809 Porterfield Way, Germantown, MD 20874 (US).
GRILLO, Adeola O. [NG/US]; 13819 Crosstie Drive, Germantown, MD 20874 (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

Abstract:
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.