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

Claim 0:
1. 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 free base or pharmaceutically acceptable salt form, wherein the composition is a finished dosage form which is a tablet, and wherein the process comprises the steps of:
(a) sieving each ingredient;
(b) combining venglustat, in free base or pharmaceutically acceptable salt form, with a diluent/filler, and with sodium stearyl fumarate as a first lubricant, and optionally with a glidant, any colors or flavors, or any other excipients, or a combination thereof;
(c) blending and/or milling and/or granulating the resulting the mixture;
(d) optionally screening the resulting mixture;
(e) adding at least one other diluent or carrier to the mixture;
(f) blending and/or milling and/or granulating the resulting mixture;
(g) optionally screening the resulting mixture;
(h) adding magnesium stearate as a second lubricant and any additional excipients;
(i) blending and/or milling the resulting mixture;
(j) optionally granulating the resulting mixture;
(k) optionally screening the resulting mixture;
(l) compressing the resulting material to form a tablet;
(m) optionally applying one or more coatings to the tablet; and
(n) optionally packaging the resulting finished dosage form.