A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61K 31/557 (2006.01) A61K 31/5575 (2006.01) A61K 31/5585 (2006.01) A61K 47/40 (2006.01)
Patent
CA 2321969
The invention relates to a process for the production of spherical granular grains (pellets), whereby the shell is a polymer, namely an ethyl cellulose or a poly(meth)acrylic acid ester and comprises at least the following properties: a) the polymer has a thickness in the range of 1 to 5% (w/w) of the total mass, whereby the total mass corresponds to the composition of the encased pellet, b) the penetration of the polymer is designed in such a way that it takes place in a stowing at a temperature of 45 to 65°C, and c) the penetration of the polymer is designed in such a way that it takes place in a stowing over at least 24 hours, and d) the pharmaceutical active ingredient is a prostane derivative. The preferred active ingredient is a 5- (E)-(1S,5S,6R)-7-hydroxy-6[(E)-(3S,4RS)-3-hydroxy-4-methyl-1- octen-6-inyl]bicyclo[3.3.0]octen-3-ylidenepentanoic acid with the additive cyclodextrin.
L'invention concerne un procédé de préparation de grains granulaires sphériques (pellets) dont l'enrobage est un polymère, notamment de la cellulose d'éthyle ou un ester d'acide poly(méth)acrylique et présente au moins les propriétés suivantes: a) le polymère a une épaisseur comprise entre 1 et 5 % (w/w) de la masse globale qui correspond à la composition du pellet enrobé; b) la pénétration du polymère est conçue de manière à intervenir pendant un recuit à une température comprise entre 45 et 65 DEG C; et c) la pénétration du polymère est conçue de manière à intervenir pendant un recuit durant au moins 24 heures; et epsilon ) le principe actif pharmaceutique est un dérivé de prostane. Le principe actif préféré est un acide 5-(E)-(1S,5S,6R)-7-hydroxy-6[(E)-(3S,4RS)-3-hydroxy-4-méthyle-1-octène-6-inyle]bicyclo [3.3.0]ctène-3-ylidènepentanique avec de la cyclodextrine comme additif.
Marks & Clerk
Schering Aktiengesellschaft
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