Pharmaceutical formulation comprising levothyroxine sodium

A - Human Necessities – 61 – K

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A61K 9/20 (2006.01)

Patent

CA 2531853

There is provided a stable pharmaceutical formulation comprising (a) an effective amount of levothyroxine sodium, (b) microcrystalline cellulose which has a mean particle size of less than 125~m and is present in an amount of 60 to 85% w/w based upon the total weight of the formulation, and (c) pregelatinised starch present in an amount of 5 to 30% w/w based upon total weight of the formulation. There is also provided a process for the preparation of such a formulation.

L'invention concerne une formulation pharmaceutique stable comprenant (a) une dose efficace de sodium de lévothyroxine, (b) de la cellulose microcristalline de dimension particulaire moyenne inférieure à 125 µm et présente en dose de 60 à 85 % en poids sur la base du poids total de la formulation, et (c) de l'amidon prégélatinisé présent en dose de 5 à 30 % en poids sur la base du poids total de ladite formulation. L'invention concerne enfin un procédé de préparation d'une telle formulation.

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