Spherical pellet containing a water-soluble active ingredient

Details Spherical pellet containing a water-soluble active ingredient Spherical pellet containing a water-soluble active ingredient

A - Human Necessities

61

K

A61K 9/16 (2006.01) A61K 9/50 (2006.01) A61K 31/135 (2006.01)

Patent

CA 2489295

A process for preparing spherical pellets comprising (a) a water-soluble active ingredient soluble, freely soluble or very soluble in water; and in particular having a water-solubility of >= 0.5 g/ml; (b) a spheronizing agent; (c) a dry lubricant, said method comprising preparing a mixture of the active ingredient, the spheronising agent, the dry lubricant; and an amount of water which is less than 5%, w/w relative to the total weight of the mixture; extruding said mixture to obtain an extrudate; and spheronising the extrudate to form spherical pellets. The invention further concerns pellets obtained by this process and sustained release oral dosage forms containing said pellets.

La présente invention concerne un procédé de préparation de granules sphériques comprenant : (a) un principe actif hydrosoluble soluble, librement soluble ou très soluble dans l'eau; et présentant en particulier une hydrosolubilité supérieure ou égale à 0,5 g/ml; (b) un agent de sphéronisation; (c) un lubrifiant sec, ledit procédé consistant à préparer un mélange constitué dudit principe actif, dudit agent de sphéronisation et dudit lubrifiant sec; et une quantité d'eau qui est inférieure à 5 %, en poids par rapport au poids total du mélange; à extruder ledit mélange afin d'obtenir un extrudat; et à sphéroniser l'extrudat afin de former des granules sphériques. L'invention concerne également des granules obtenus selon ledit procédé ainsi que des formes posologiques orales à libération prolongée contenant lesdits granules.

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