PHARMACEUTICAL FORMULATION AND PROCESS

PHARMACEUTICAL FORMULATION AND PROCESS
Inventor: KRISHNAMURTHY RAJESH (US); SURYANARAYANAN RAJ (US)
Applicant: HUMAN GENOME SCIENCES INC (US); KRISHNAMURTHY RAJESH (US)
IPC: A61K39/00; A61K39/00
Publication info: WO2006014965
Date: 2006-02-09
Abstract of WO2006014965
A process for lyophilization or freeze-drying of a pharmaceutical product is provided and a liquid formulation suitable for lyophilization. In particular, a process for lyophilization or freeze-drying a liquid formulation that includes a protein active agent, a bulking agent and a saccharide stablilizing agent is provided. The saccharide to bulking agent ratio and the protein concentration of the formulation are important factors that affect crystallization of the bulking agent during lyophilization and storage as are some processing conditions. In one embodiment, the saccharide is a disaccharide, such as sucrose and the crystalline bulking agent is mannitol. The protein can be an antibody or a non-antibody protein.
Comments: 0
Votes:34