Patent ID: 8808739

Claim:
A process for the preparation of an orodispersible tablet comprising sildenafil base, the process comprising: (i) mixing respective amounts of components (a), (b), (c), and (d) together, wherein: component (a) is sildenafil base having a particle size distribution (D50) of 1 μm to 25 μm; component (b) is a wicking agent selected from the group consisting of microcrystalline cellulose, silicified microcrystalline cellulose, kaolin, titanium dioxide, fumed silica, aluminium, niacinamide, N-methyl-2-pyrrolidone, bentonite, magnesium-aluminium silicate, and combinations thereof; component (c) is a disintegrant; component (d) is a glidant; and the respective amounts of components (a), (b), and (c) satisfy both the following conditions: (1) the weight ratio of component (a) to components (b)+(c) is in the range of 1:1 to 3:1 and (2) the weight ratio of component (b) to component (c) is in the range of 3:1 to 7:1; (ii) compacting the mixture of step (i); (iii) milling the compacted mixture of step (ii); (iv) mixing together the product of step (iii), a pharmaceutically-acceptable lubricant, an additional amount of a disintegrant, and at least one further pharmaceutical excipient; and (v) compressing the mixture of step (iv) to yield an orodispersible tablet, wherein the respective amount of sildenafil base (component (a)) selected in step (i) is sufficient to comprise no less than 45% by weight of the orodispersible tablet and is insufficient to comprise more than 70% by weight of the orodispersible tablet.