Pharmaceutical formulations of gpr119 agonists and uses thereof
AssigneeMankind Pharma Ltd.
InventorsDheeraj FULARA, KS HAREEN, Rashmi Ranjan PANDA, Chithambaram MUTHULINGAM, Santosh Kumar RAI, Anil KUMAR
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Abstract
The present disclosure relates to oral pharmaceutical formulations comprising a compound of Formula I or a pharmaceutically acceptable salt thereof wherein R, A and n are as described herein. The present disclosure also relates to processes for their preparation and their use in treating disorders such as cardiovascular and metabolic disorders, including diabetes.
Claims14
An oral pharmaceutical composition comprising a compound of Formula I or a pharmaceutically acceptable salt thereof:
- wherein
- each R is independently selected from H, halogen, substituted or unsubstituted C1-4 alkyl, and substituted or unsubstituted C1-4 alkoxy;
- A is selected from H, substituted or unsubstituted C1-4 alkyl, substituted or unsubstituted phenyl, substituted or unsubstituted (C1-4 alkyl)phenyl, substituted or unsubstituted 5-6 membered heteroaryl containing one or more heteroatoms selected from N, O, and S, substituted or unsubstituted heterocyclyl containing one or more heteroatom selected from N, O, and S, and substituted or unsubstituted C1-4 alkoxycarbonyl;
- wherein the substituents are selected from halogen, substituted or unsubstituted C1-4 alkyl, and substituted or unsubstituted C1-4 alkoxy;
- n is 0, 1, 2, or 3;
- and
- * denotes a stereocenter;
- and one or more pharmaceutically acceptable excipients,
- wherein the compound of Formula I has a particle size D90 of less than about 200 μm.
A compressed tablet comprising a compound of Formula IA or a pharmaceutically acceptable salt thereof
- dispersed in
- (a) a non-ionic, water dispersible surfactant;
- (b) colloidal silicon dioxide;
- (c) crospovidone;
- and
- (d) spray-dried (i) D-mannitol, (ii) xylitol, (iii) microcrystalline cellulose, (iv) crospovidone, and (v) dibasic calcium phosphate;
- wherein the compound of Formula IA has a particle size D90 of less than about 200 μm.
An oral aqueous suspension comprising:
- (a) a compound of Formula IA or a pharmaceutically acceptable salt thereof
- and
- (b) 2-hydroxypropyl beta-cyclodextrin.
Dependencies are inferred from the claim text.