Pharmaceutical excipient having improved compressibility

Details Pharmaceutical excipient having improved compressibility Pharmaceutical excipient having improved compressibility

A - Human Necessities

61

K

A61K 47/38 (2006.01) A61K 9/14 (2006.01) A61K 9/20 (2006.01) B01J 2/00 (2006.01)

Patent

CA 2183882

A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression. Figure graphically shows a comparison of the tensile strength of tablets prepared in accordance with the invention and prior art tablets. Dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and an effective amount of a surfactant, which in preferred embodiments is an anionic surfactant present in amounts ranging from about 0.1% to about 0.5 %, by weight of the microcrystalline cellulose, wherein the microcrystalline cellulose and surfactant are in intimate association with each other. One preferred anionic surfactant utilized in the novel excipient is sodium lauryl sulfate.

L'invention a pour objet un excipient à base de cellulose microcristalline présentant une compressibilité améliorée, utilisé dans des formulations par compression directe, granulation par voie sèche ou granulation par voie humide. La figure illustre graphiquement une comparaison de la résistance à la traction entre des comprimés préparés selon l'invention et des comprimés actuels. L'excipient est un aggloméré de particules de cellulose microcristalline et d'une quantité efficace d'un agent tensio-actif qui, dans les modes de réalisation préférés, est un agent tensio-actif anionique dont la quantité se situe entre 0,1 et 0,5 % en poids de la cellulose microcristalline, la cellulose microcristalline et l'agent tensio-actif étant étroitement associés. Un agent tensio-actif anionique préféré utilisé dans le nouvel excipient est du laurylsulfate de sodium.

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