Drug-containing coated microparticles for...

A - Human Necessities – 61 – K

Patent

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Details

A61K 9/50 (2006.01) A61K 47/32 (2006.01) A61K 47/34 (2006.01) A61K 47/36 (2006.01) A61K 47/38 (2006.01)

Patent

CA 2543454

Drug-containing coated microparticles for orally disintegrating tablet, characterized in that in order to, with respect to drugs of highly unpleasant taste, effect satisfactory control of drug elution in the oral cavity and attain rapid drug elution in the digestive tract, microparticles containing a drug of unpleasant taste are covered by a coating comprised of a water insoluble polymer of no pH dependence (1) amounting to 60 to less than 80% in proportion in the coating and a water soluble substance of no pH dependence (2) amounting to more than 20 to 40% in proportion in the coating to thereby cause the ratio of drug elution from drug-containing microparticles to be 0 to 10% in one minute and 80 to 100% in 30 minutes and cause the average particle diameter to 350 µm or less.

L'invention concerne des microparticules enrobées contenant un médicament destinées à un comprimé à dissolution orale. Par rapport aux médicaments présentant un goût très désagréable, l'invention se caractérise en ce que, pour produire une régulation satisfaisante de l'élution du médicament dans la cavité orale et obtenir une élution rapide du médicament dans le tractus digestif, les microparticules contenant un médicament présentant un goût désagréable sont recouvertes d'un enrobage constitué d'un polymère insoluble dans l'eau non tributaire du pH (1) dont la proportion dans l'enrobage est comprise entre 60% et moins de 80%, et d'une substance hydrosoluble non tributaire du pH (2) dont la proportion dans l'enrobage est comprise entre plus de 20% et 40%, ce qui permet d'obtenir un rapport d'élution médicamenteuse à partir de ces microparticules compris entre 0% et 10% en une minute et entre 80% et 100% en 30 minutes, ainsi qu'un diamètre moyen des particules inférieur ou égal à 350 µm.

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