Claims for Patent: 10,925,871

Summary for Patent: 10,925,871

Title:	Pharmaceutical compositions of sitagliptin
Abstract:	The present invention relates to stable oral pharmaceutical compositions of sitagliptin base and processes for the preparation thereof.
Inventor(s):	Khera Brij, Kannan Muthaiyyan Essakimuthu, Patel Jitendra Rameshchandra, Amin Saurin Mukundbhai
Assignee:	CADILA HEALTHCARE LIMITED
Application Number:	US15121514
Patent Claims:	1. A stable pharmaceutical composition comprising sitagliptin base and at least one beneficial agent in an amount of about 1% to about 20% by weight of the composition , wherein the beneficial agent is a pH modifying agent which provides pH from about 3 to about 8 to the composition; wherein the pH modifying agent is selected from the group consisting of gluconic acid , lactic acid , glycolic acid , ascorbic acid , malic acid , tartaric acid , tartronic acid and mucic acid; and wherein the composition contains less than 0.2% by weight of 3-Trifluoromethyl-5 ,6 ,7 ,8-tetrahydro-[1 ,2 ,4]triazolo[4 ,3-a]pyrazine hydrochloride (impurity-I) wherein the composition is prepared by a process comprising the steps of:(a) mixing the sitagliptin base and one or more pharmaceutically acceptable excipients; granulating the mixture with or without a binder solution to obtain sitagliptin granules and optionally coating the granules;(b) mixing at least one beneficial agent and one or more pharmaceutically acceptable excipients; granulating the mixture with or without a binder solution to obtain granules and optionally coating the granules;(c) blending the granules obtained in step (a) and (b) with one or more pharmaceutically acceptable excipients; and(d) compressing the blended granules into a tablet.2. The stable pharmaceutical composition according to claim 1 , wherein the sitagliptin is in an amorphous form.3. The stable pharmaceutical composition according to claim 1 , wherein the sitagliptin is in a crystalline form.4. The stable pharmaceutical composition according to claim 1 , wherein the sitagliptin has an average particle size diameter below 25 microns.5. The stable pharmaceutical composition according to claim 1 , wherein the composition further comprises one or more pharmaceutically acceptable excipients comprising diluents claim 1 , binders claim 1 , disintegrants claim 1 , glidants claim 1 , lubricants claim 1 , sweeteners/taste masking agents claim 1 , compression aids claim 1 , colorants claim 1 , flavors or the combinations thereof.6. The stable pharmaceutical composition according to claim 1 , wherein the composition is in the form of a solid dispersion.7. The stable pharmaceutical composition according to claim 1 , wherein the beneficial agent is malic acid.