Orally dispersible tablet containing compacted sildenafil base

摘要

The invention relates to a process for the preparation of a pharmaceutical intermediate, comprising the steps of (i) mixing (a-i) sildenafil base, (b-i) wicking agent, (c-i) disintegrant, (d-i) optionally glidant; (ii) compacting the mixture; and (iii) milling the compacted material; and to an intermediate obtainable by that process. In addition, the invention relates to a process for the preparation of an orally dispersible tablet (hereinafter also referred to as an “orodispersible tablet”) comprising the intermediate of the invention, and to orodispersible tablets obtainable by that process.

主权项

1. An orodispersible tablet comprising:
45-70 wt % sildenafil base, wherein the particle size distribution (D50) of the sildenafil base is 1-25 μm; 10-35 wt % microcrystalline cellulose; and 5-20 wt % of a disintegrant, wherein the disintegrant is selected from the group consisting of crospovidone, sodium starch glycolate, and combinations thereof.