TABLET FORMULATION FOR CGRP ACTIVE COMPOUNDS

摘要

The present invention is directed to compositions comprising an extrudate or solid solution of a compound, or a salt thereof, of Formula I (API): Formula I, wherein “Ra” is independently H or —F, in a water-soluble polymer matrix which further comprises a disintegration system allowing a tablet made therefrom to rapidly disintegrate in the environment in which the API is to be released.;

主权项

1) A tablet comprising:
(a) an extrudate comprising:
(i) a water-soluble polymer matrix;(ii) a dispersing agent; and(iii) a compound of Formula I, or a pharmaceutically acceptable salt thereof:wherein “Ra” is independently —H or —F, and wherein the dispersing agent and compound of Formula I is dispersed within said polymer matrix; and
(b) a disintegration system,wherein said tablet has a hardness of from about 12 kP to about 18 kP, and wherein said tablet achieves complete disintegration in less than about 5 minutes in a standard tablet disintegration test complying with USP 31-NF26 Chapt. 701 using aqueous HCl (pH 1.8) at 37° C.