Method for production of orally rapidly disintegrating tablet comprising imidafenacin as active ingredient
The present invention herein provides an imidafenacin-containing orally rapidly disintegrating 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.
1. A method for preparing an orally rapidly disintegrating tablet comprising:
granulating imidafenacin together with starch such that a granulated product comprising the imidafenacin having an imidafenacin concentration ranging from 0.001 to 3% by mass and the starch having a starch concentration ranging from 40 to 99.999% by mass is prepared;
covering the granulated product with a non-cellulosic coating agent such that a coated granulated product comprising the granulated product and the non-cellulosic coating agent coating the granulated product is prepared;
blending the coated granulated product with an excipient and a disintegrating agent such that a resulting mixture comprising the excipient, the disintegrating agent and the coated granulated product is prepared; and
forming the resulting mixture into a tablet according to a compression molding technique.
2. The method of claim 1 , wherein the non-cellulosic coating agent is an aminoalkyl methacrylate copolymer.
3. The method of claim 1 , wherein the non-cellulosic coating agent is aminoalkyl methacrylate copolymer E.
4. The method of claim 1 , wherein the non-cellulosic coating agent is a polyvinyl acetal diethylaminoacetate.
5. The method of claim 1 , wherein the imidafenacin concentration of the granulated product has the imidafenacin concentration ranging from 0.2 to 0.6% by mass.
6. The method of claim 1 , wherein the starch concentration of the granulated product has the starch concentration ranging from 60 to 99.999% by mass.
7. The method of claim 1 , wherein the starch concentration of the granulated product has the starch concentration ranging from 70 to 99.999% by mass.
8. The method of claim 2 , wherein the imidafenacin concentration of the granulated product has the imidafenacin concentration ranging from 0.2 to 0.6% by mass.
9. The method of claim 2 , wherein the starch concentration of the granulated product has the starch concentration ranging from 60 to 99.999% by mass.
10. The method of claim 2 , wherein the starch concentration of the granulated product has the starch concentration ranging from 70 to 99.999% by mass.
11. The method of claim 3 , wherein the imidafenacin concentration of the granulated product has the imidafenacin concentration ranging from 0.2 to 0.6% by mass.
12. The method of claim 3 , wherein the starch concentration of the granulated product has the starch concentration ranging from 60 to 99.999% by mass.
13. The method of claim 3 , wherein the starch concentration of the granulated product has the starch concentration ranging from 70 to 99.999% by mass.
14. The method of claim 4 , wherein the imidafenacin concentration of the granulated product has the imidafenacin concentration ranging from 0.2 to 0.6% by mass.
15. The method of claim 4 , wherein the starch concentration of the granulated product has the starch concentration ranging from 60 to 99.999% by mass.
16. The method of claim 4 , wherein the starch concentration of the granulated product has the starch concentration ranging from 70 to 99.999% by mass.
17. The method of claim 1 , further comprising drying the granulated product.
18. The method of claim 1 , wherein the non-cellulosic coating agent is povidone.
19. The method of claim 1 , wherein the non-cellulosic coating agent is a methacrylic acid copolymer.
20. The method of claim 1 , wherein the non-cellulosic coating agent is an ammonio-methacrylate copolymer.