Medical devices and methods including polymers having...

A - Human Necessities – 61 – K

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A61K 9/00 (2006.01) A61K 31/4162 (2006.01) A61L 27/54 (2006.01) A61K 9/16 (2006.01)

Patent

CA 2700561

The implant design is a drug loaded polymer device, such as a rod, designed to control the release of a biologically active agent, such as clonidine or its derivatives, such as clonidine HCl for a prolonged period of time, such as 2 months, 3 months, 4 months, and even 4.5 months. The polymer is preferably a biodegradable polymer, such as poly(lactide-co-glycolide) or polylactic acid/polylactide. The chal-lenge in using the HCl salt forms of drugs such as clonidine, is controlling the release of the highly water soluble drug for up to 4.5 months. It has been found that by controlling the particle size distribution of the drug powder, the drug distribution within the polymer matrix is more uniform and can be con-trolled. Therefore, the large aggregates, which cause rapid drug release can be eliminated.

Linvention concerne une conception dimplant constituant un dispositif polymère chargé de médicament, tel quune baguette, conçu pour réguler la libération dun principe biologiquement actif, tel que la clonidine ou ses dérivés, tel que le HCl de clonidine, pendant une durée prolongée, par exemple 2, 3, 4 mois, voire 4 mois et demi. Le polymère est de préférence un polymère biodégradable, tel que le poly(lactide-co-glycolide) ou acide polylactique/polylactide. La difficulté liée à lutilisation des formes salines HCl de médicaments tels que la clonidine est de réguler la libération de ce médicament hautement hydrosoluble pendant une durée prolongée allant jusquà 4 mois et demi. Il a été prouvé que la régulation de la répartition de la taille des particules de la poudre de médicament permettait dobtenir une répartition de médicament plus uniforme et plus facilement régulable à lintérieure de la matrice polymère. Ainsi, les gros agrégats entraînant une libération rapide de médicament peuvent être éliminés.

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