A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61K 38/18 (2006.01)
Patent
CA 2214889
The invention concerns parenteral pharmaceutical forms of administration containing polypeptide in the form of microparticles and a process for the production thereof. The microparticles according to the invention contain as a biodegradable polymer an ABA triblock copolymer the A block of which is a copolymer of lactic and glycolic acid and the B block of which represents a polyethylene glycol chain, together with additives that are selected from the group comprising serum proteins, polyamino acids, cyclodextrins, cyclodextrin derivatives, saccharides, amino sugars, amino acids, detergents or carboxylic acids as well as mixtures of these additives. The microparticles according to the invention continuously release the polypeptide over a relatively long time period even when the amounts of polypeptide they include are small or susceptible to aggregation.
L'invention concerne des formes galéniques pharmaceutiques parentérales contenant un polypeptide, sous forme de microparticules, ainsi qu'un procédé de préparation desdites formes galéniques. Ces microparticules contiennent, sous forme de polymère biodégradable, un copolymère triséquencé ABA, dont la séquence A est un copolymère d'acide lactique et d'acide glycolique et dont la séquence B est une chaîne polyéthylèneglycol, avec des additifs sélectionnés dans le groupe des protéines sériques, polyaminoacides, cyclodextrines, dérivés de cyclodextrine, saccharides, aminosucres, aminoacides, détergents ou acides carboxyliques ainsi que des mélanges de ces additifs. Ces microparticules libèrent en continu le polypeptide sur une longue période, même si les proportions de polypeptide qu'elles renferment sont faibles et sensibles à l'agrégation.
Kissel Thomas
Koll Hans
Morlock Michael
Winter Gerhard
Boehringer Mannheim Gmbh
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
Roche Diagnostics Gmbh
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