Process for manufacturing sustained release microbeads...

A - Human Necessities – 61 – K

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A61K 9/24 (2006.01) A61K 9/50 (2006.01) A61K 31/137 (2006.01)

Patent

CA 2507685

The present invention relates to viable continuous process for manufacture of agglomeration free, high yield (generally atleast about 95% w/w), uniformly shaped and sized, stable novel pharmaceutical composition of adequate strength comprising upto about 70%w/w of Venlafaxine or its pharmaceutical acceptable salt which is free of organic acid for once a day dosing. Sustained release composition comprising of Venlafaxine HCI provides pH independent release of Venlafaxine HCI atleast for a period of 10 hours without any latent period and can be encapsulated in smallest capsule size 5 for therapeutic effective of Venlafaxine thus providing patient easy to consume dosage form.

La présente invention concerne un procédé continu et viable de fabrication d'une nouvelle composition pharmaceutique stable sans agglomeration et à haut rendement (généralement au moins environ 95 % w/w), d'une forme et d'une dimension uniformes et d'une résistance adéquate, comprenant jusqu'à environ 70 % w/w de Venlafaxine ou d'un sel acceptable d'un point de vue pharmaceutique de celle-ci, sans acide organique, et administrée une fois par jour. Cette composition à libération prolongée comprenant de la Venlafaxine HCI permet une libération indépendant du pH de la Venlafaxine HCI pendant au moins une durée de 10 heures sans aucune période latente, et peut être encapsulée dans des petites capsules de taille 5 pour obtenir un effet thérapeutique de la Venlafaxine, permettant ainsi d'obtenir une forme de dosage facile à ingérer pour le patient.

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