Pharmaceutical compositions comprising venglustat
AssigneeGenzyme Corporation
InventorsAudrey JEANJEAN, Danielle COMBESSIS, David RIGAL, Chris HO, Pankaj TANEJA
Life of this patent
Estimating the term…
Abstract
The present disclosure relates to pharmaceutical compositions, including dosage forms, such as tablets or capsules, comprising venglustat, in free base, or pharmaceutically acceptable salt form, a diluent/filler and a lubricant, optionally in combination with one or more additional therapeutic agents, to processes for manufacture thereof, and to methods of use in the treatment or prevention of disease.
Claims27
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-ylcarbamate:
- in free base or pharmaceutically acceptable salt form, 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 optionally with a lubricant, 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, such as additional diluent/filler, a disintegrant, a binder, a lubricant, or any other excipient, or a combination thereof, wherein, if a lubricant is not combined with the venglustat and the diluent/filler in step (b), a lubricant is added to the mixture;
- (f) blending and/or milling and/or granulating the resulting mixture;
- (g) optionally screening the resulting mixture;
- (h) adding a lubricant and any additional excipients;
- (i) blending and/or milling the resulting mixture;
- (j) granulating the resulting mixture;
- (k) optionally screening the resulting mixture;
- (l) encapsulating the resulting material;
- or compressing the resulting material to form a tablet;
- (m) optionally applying one or more coatings to the capsule, tablet, or other dosage form;
- and
- (n) optionally packaging the resulting finished dosage form.
An oral pharmaceutical composition comprising venglustat, (S)-quinuclidin-3-yl 2-(2-(4-fluorophenyl)thiazol-4-yl)propan-2-ylcarbamate:
- in free base or pharmaceutically acceptable salt form, a diluent/filler, and a lubricant.
(canceled)
Dependencies are inferred from the claim text.