The present invention provides a novel amorphous form of vildagliptin process for its preparation and pharmaceutical compositions comprising it. The present invention also provides a solid dispersion of vildagliptin in combination with a pharmaceutically acceptable carrier process for its preparation and pharmaceutical compositions comprising it. Vildagliptin (LAF237) is an oral anti-hyperglycemic agent (anti-diabetic drug) of the new dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs.

The present invention relates to a method of treating diabetes type II by delivery of butyric acid, bile acid, long chain fatty acid or glutamine to the colon by bypassing the upper digestive tract. The composition is combined either by the same or different route of administration with a DPP-IV inhibitor such as vildagliptin.

Provided is an improved process for preparation of Vildagliptin intermediate, 1-chloro acetyl (S)-2-cyano pyrrolidine.

The present invention provides a novel amorphous Form of vildagliptin, process for its preparation and pharmaceutical compositions comprising it. The present invention also provides a solid dispersion of vildagliptin in combination with a pharmaceutically acceptable carrier, process for its preparation and pharmaceutical compositions comprising it.

The present invention relates to a pharmaceutical combination formulation comprising vildagliptin or a pharmaceutically acceptable salt of vildagliptin glimepiride or a pharmaceutically acceptable salt of glimepiride and at least one coating layer.

A process for preparation of vildagliptin is discussed wherein 3-amino-1- adamantanol is reacted with 1-chloroacetyl(S)-2-cyanopyrrolidine in solvent and base to obtain vildagliptin. This invention also relates to a process for preparation of 1-chloroacetyl(S)-2-cyanopyrrolidine, a vildagliptin intermediate is provided. Further, the present invention also provides a co- precipitate of amorphous form of vildagliptin along with pharmaceutically acceptable excipients.

This invention relates to a formulation comprising a dipeptidylpeptidase IV (DPP-IV) inhibitor preferably vildagliptin and metformin to tablets comprising such formulations and to processes for the preparation thereof.