Tablets exhibiting reduced drug release variability

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/20 (2006.01) A61K 9/24 (2006.01)

Patent

CA 2566931

A compressible extended release tablet or tablet layer having a drug release profile that is not strongly dependent on tablet hardness may be prepared by dry blending a pharmaceutically active ingredient with hydroxypropyl methylcellulose, wherein the hydroxypropyl methylcellulose has a bimodal or multimodal number average molecular weight distribution that includes at least one mode over 20,000 Daltons and at least one mode under 10,000 Daltons. An additional advantage of the invention is that the tablet formulations may be prepared without resort to wet granulation.

Selon l'invention, un comprimé ou une couche de comprimé compressible à libération prolongée présentant un profil de libération qui n'est pas fortement dépendant de la rigidité du comprimé peut être préparé par mélange à sec d'un ingrédient actif sur le plan pharmaceutique avec de l'hydroxypropylméthylcellulose, ce dernier possédant une répartition de poids moléculaire moyen en nombre bimodale ou multimodale qui comprend au moins un mode supérieur à 20000 Daltons et au moins un mode inférieur à 10000 Daltons. Un avantage supplémentaire de l'invention réside en ce que les formulations desdits comprimés peuvent être préparées sans avoir recours à la granulation par voie humide.

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