Microspheres comprising protein and showing injectability at...

Details Microspheres comprising protein and showing injectability at... Microspheres comprising protein and showing injectability at...

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 39/00 (2006.01) A61K 47/42 (2006.01)

Patent

CA 2566075

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.

Cette invention concerne la composition de microparticules incluant une suspension de microparticules de protéine amorphe conséquentes, cette composition produisant une concentration minimale d'environ 50mg de ladite protéine par ml de ladite composition, et dont cette même protéine présente un poids moléculaire minimal de 25 000 Daltons. En conformité avec la méthode de production, l'agent actif est dissous dans un solvant aqueux ou miscible dans l~eau contenant un agent d'amélioration de séparation de phases (PSEA) afin de former une solution en phase liquide unique. Cette solution est soumise à une séparation des phases liquides et solides pour provoquer une formation par l'agent actif de petites sphéricités considérablement amorphes ou non cristallines, et injectables par le biais d'aiguilles de la bonne grosseur à d'importantes concentrations. Cette invention doit être appliquée de manière spécifique en ce qui concerne les protéines dont le poids moléculaire est plus important.

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