Oral medicament based on a proton pump inhibitors

Details Oral medicament based on a proton pump inhibitors Oral medicament based on a proton pump inhibitors

A - Human Necessities

61

K

A61K 9/62 (2006.01) A61K 31/4184 (2006.01) A61K 31/4439 (2006.01) A61P 1/04 (2006.01)

Patent

CA 2608185

The invention relates to oral medicaments having a modified release of proton pump inhibitors (PPI's) that are, in particular, useful in preventing and treating gastrointestinal disorders. The aim of the invention is to provide a novel oral medicament based on PPI's ideally having all or some of the following characteristics: a) quickly providing relief to the patient by increasing the gastric pH after oral administration of the medicament; b) accelerating the recovery of patients while maintaining this increase in the gastric pH for as long as possible after oral administration of the medicament and, in particular, during the night; c) improving the observance of the treatment and the comfort of the patient by taking the medicament once daily. To this end, the microcapsules of the invention, preferably non-enteric, are constituted of PPI microparticles coated with ethyl cellulose, an ammonio methacrylate copolymer (Eudragit® RL 100), polyvinylpyrrolidone, castor oil and polyoxyethylenated hydrogenated castor oil (40). This medicament is designed so that after its ingestion for a once daily administration, it makes it possible to maintain, from the first day of treatment onward, an average gastric pH, between 0 and 24h, of greater than or equal to the average gastric pH between 0 and 24h obtained by an enteric oral medicament having a reference* immediate release, administered under the same conditions. The invention also relates to these microcapsules per se.

L'invention concerne des médicaments oraux à libération modifiée d'IPP, plus particulièrement utiles pour la prévention et le traitement des troubles gastro- intestinaux. Le but de l'invention est de fournir un nouveau médicament oral à base de d' IPP présentant idéalement tout ou partie des caractéristiques suivantes : a) Soulager rapidement le patient par une élévation du pH gastrique, après la prise orale du médicament, b) Accélérer la guérison des patients en maintenant cette élévation du pH gastrique, le plus longtemps possible, après la prise orale du médicament, et en particulier durant la nuit, c) Améliorer l'observance du traitement et le confort du patient par une prise journalière unique. Pour atteindre ce but, les microcapsules de l'invention, de préférence non entériques, sont constituées de microparticules d'IPP enrobées par de l' éthylcellulose, un copolymère ammonio-methacrylate (Eudragit~ RL 100) , de la polyvinylpyrrolidone, de l'huile de ricin et de l'huile de ricin hydrogénée polyoxyéthylénée (40) . Ce médicament est conçu de telle sorte qu'après son ingestion pour une administration en une prise journalière unique, il permet de maintenir, dès le premier jour du traitement, un pH gastrique moyen entre 0 et 24h, supérieur ou égal au pH gastrique moyen entre 0 et 24h obtenu avec un médicament oral entérique à libération immédiate de référence*, administré dans les mêmes conditions. L'invention vise également ces microcapsules per se.

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