Method for making pharmaceutical tablets by compression

Details Method for making pharmaceutical tablets by compression Method for making pharmaceutical tablets by compression

A - Human Necessities

61

J

A61J 3/10 (2006.01) A61K 9/20 (2006.01)

Patent

CA 2367850

The invention concerns a method for making pharmaceutical tablets by compressing a base powder, generally consisting of one or several binders, a disintegrating agent and the active principle. The invention is characterised in that, prior to compression, it consists in adding to the base powder, talc with a grain size distribution such that the mean diameter D¿50? is not more than 4.5 microns, advantageously between 0.5 and 2.5 microns, the cut diameter D¿95? being preferably not more than 15 microns. The method enables to obtain satisfactory mechanical lubrication when the tablets are compressed (enabling high production rates without excess heating or binding), while avoiding or limiting the use of an organic lubricant.

L'invention concerne un procédé de fabrication de comprimés pharmaceutiques par compression d'une poudre de base, généralement composée d'un ou de plusieurs liants, d'un désintégrant et du principe actif. Selon l'invention, préalablement à la compression, on ajoute à la poudre de base, du talc présentant une répartition granulométrique telle que le diamètre moyen D50 soit inférieur ou égal à 4,5 microns, avantageusement compris entre 0,5 et 2,5 microns, le diamètre de coupure D95 étant de préférence inférieur ou égal à 15 microns. Le procédé permet d'obtenir une lubrification mécanique satisfaisante lors de l'opération de compression des comprimés (autorisant des cadences élevées sans échauffement excessif ni grippage), tout en évitant ou en limitant l'utilisation d'un lubrifiant organique.

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