VERED BISKER -LEIB,LARRY BROWN,DEBRA LAFRENIERE,JULIA RASHBA -STEP,TERRENCE L SCOTT,JOHN MCGEEHAN
申请号：
IN6110/DELNP/2006
公开号：
IN260307B
申请日:
2006.10.19
申请国别(地区):
IN
年份:
2014
代理人:
摘要：
The present invention relates to composition of microparticles comprising a suspension of substantially amorphous protein microparticles, the composition providing a concentration of at least about 50 mg of said protein per ml of said composition, and the protein has a molecular weight of at least about 25,000 Daltons. In accordance with the method of production, the active agent is dissolved in an aqueous or aqueous-miscible solvent containing a dissolved phase-separation enhancing agent (PSEA) to form a solution in a single liquid phase. The solution is subjected to a liquid-solid phase separation to cause the active agent to form small spherical that are substantially amorphous or non-crystalline and are injectable through fine gauge needles at high concentrations. The invention has special application for higher molecular weight proteins.
