A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 9/52 (2006.01) A61K 9/50 (2006.01)
Patent
CA 2493464
The invention concerns microcapsules for reliably modified release and adapted to industrial reproduction of an active principle hardly water-soluble, other than anti-hyperglycemia agents Each of said microcapsules comprises a core of hardly soluble active principle and a coating film applied on the core. Their mean diameter is less than 1000 microns. The coating film contains a film-forming polymer (P1) insoluble in gastrointestinal tract fluids, a water-soluble polymer (P2), a plasticizer (PL), and optionally a lubricating surfactant (TA). Said coating film represents at least 4 % p/p of dry matter of their total weight, and its components P1, P2, PL satisfy the following characteristics: dry weight mass fraction of P1 relative to the total coating weight ranging between 40 and 90 %; dry matter weight fraction of PL/P1+P2 ranging between 15 and 60 %; dry matter weight fraction of PL/P1+PL ranging between 1 and 30 %. The invention also concerns the uses of said microcapsules in galenic formulation.
La présente invention concerne des microcapsules permettant la libération modifiée de façon fiable et industriellement reproductible d'un principe (PA) peu soluble dans l'eau, àl'exclusion des anti-hyperglycémiants. Chacune de ces microcapsules comprend un coeur de PA peu soluble et une pellicule d'enrobage appliquée sur le coeur . Leur diamètre moyen est inférieur à 1000 microns. La pellicule d'enrobage contient un polymère filmogène (P1) insoluble dans les liquides du tractus gastro-intestinal; un polymère hydrosoluble (P2); un plastifiant (PL); et éventuellement un agent tensioactif (TA) lubrifiant . Cette pellicule d'enrobage représente au moins 4 % p/p sec de leur masse totale,et ses composants P1, P2, PL satisfont aux caractéristiques suivantes : fraction massique en poids sec de P1 par rappor tà; la masse totale de l'enrobage, comprise entre 40 et 90%;fraction massique en poids sec P2/P1+P2 comprise entre 15 et 60 %; fraction massique en poids sec PL/P1+PL comprise entre 1 et 30 %.L'invention concerne aussi les applications desdites microcapsules en galénique.
Castan Catherine
Guimberteau Florence
Meyrueix Remi
Soula Gerard
Flamel Technologies
Robic
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