Research on: “Formulation Development and Evaluation of Immediate Release Tablet of Linagliptin”

Research on: “Formulation Development and Evaluation of Immediate Release Tablet of Linagliptin”

Ms. Rani Sanjay Naik, Mr. Vinayak Munde.

ABSTRACT
The present study work aimed to formulate and evaluate an immediate-release tablet anti- diabetic drug for managing diabetes mellitus type 2.

Linagliptin is a selective inhibitor of the enzyme dipeptidyl peptidase metabolizes the naturally occurring incretions- peptide insulin tropic polypeptide resulting in enhanced glucose in the pancreas and decreased hepatic glucose production. Immediate release tablet of Linagliptin prepared by direct compression method. Tablets were prepared using excipients such as microcrystalline cellulose, Lactose monohydrate, Croscarmellose sodium, & Magnesium stearate in different ratios by the direct compression method. The Compatibility of drug and excipient studies showed no interaction between drug and excipient. The prepared formulations show satisfactory results when subjected to various physicochemical tests such as weight of variation, Hardness, thickness, disintegration Time, Friability, and Assay. The formulations were also subjected to evaluation of in vitro drug release by using US Dissolution Apparatus II. Optimized formulation F6 showed in-vitro release above 85% at the Q time point. The individual steps were improved for the same and the scale-up contemplation has been engaged into account to certify the product performance at pilot plant-up to commercial scale-up.

Keywords: Linagliptin, Anti-diabetic drugs, Compatibility, Immediate-release table.