A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/4164 (2006.01) A61K 9/22 (2006.01) A61K 47/32 (2006.01) A61K 47/36 (2006.01) A61K 47/38 (2006.01) A61P 13/10 (2006.01) A61P 43/00 (2006.01)
Patent
CA 2713677
The present invention herein provides an imidafenacin-containing orally rapidly integrating tablet which is excellent in the photostability. The present invention comprises the steps of: (A) granulating imidafenacin together with starch to thus give a granulated product having an imidafenacin concentration ranging from 0.001 to 3% by mass and a starch concentration ranging from 40 to 99.999% by mass; (B) covering the granulated product prepared in the step (A) with a non-cellulosic coating agent; and (C) blending the granulated product obtained in the preceding step (B) with an excipient and a disintegrating agent and then forming the resulting mixture into a tablet according to the compression molding technique.
Comprimé à administration orale à désintégration rapide comprenant de l'imidafénacine, à excellente stabilité optique. Les opérations de fabrication (A) à (C) de ce comprimé sont les suivantes: (A) granulation de l'imidafénacine avec de l'amidon pour obtention d'un matériau dont la teneur en imidafénacine est comprise entre 0,001 et 3% en masse et celle de l'amidon entre 40 et 99,999% en masse; (B) enrobage du matériau granulé produit en (A) dans un agent d'enrobage non cellulosique; et (C) mélange du matériau granulé enrobé obtenu en (B) avec un excipient et un désintégrant, et compression et mise en forme du mélange.
Aoki Yoshinobu
Ishizaki Toshihiro
Kyorin Pharmaceutical Co. Ltd.
Norton Rose Or S.e.n.c.r.l. S.r.l./llp
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