Patent ID: 11857512
Assignee: GENZYME CORPORATION
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 10:
11. A process for the manufacture of an oral pharmaceutical composition comprising venglustat, (S)-quinuclidin-3-yl(2-(2-(4-fluorophenyl)thiazol-4-yl)propan-2-yl)carbamate:, , in malate salt form, wherein the composition is a finished dosage form which is a capsule, wherein the process comprises the following steps:
(a) sieving one or more ingredients to be used in step (b);
(b) combining venglustat malate with a first portion of microcrystalline cellulose, and croscarmellose sodium, optionally sucralose and optionally flavor, optionally wherein these ingredients are not previously sieved;
(c) blending and/or milling and/or granulating the resulting mixture;
(d) optionally sieving the resulting mixture;
(e) adding a second portion of microcrystalline cellulose, silica, and a first portion of magnesium stearate to the mixture from step (c), optionally wherein these added ingredients are previously sieved from step (a);
(f) blending and/or milling and/or granulating the resulting mixture;
(h) sieving the remaining portion of magnesium stearate and/or adding it to the mixture from step (f);
(i-j) blending and/or milling and/or granulating the resulting mixture;
(l) filling the resulting material into hard capsules; and
(n) optionally packaging the resulting finished dosage form.