Abstract

*Kapil Kumar, Gurleen Kaur, Suraj, Deepak Teotia

ABSTRACT

Formulation development is an important part of drug design and development. Bioavailability and bioequivalence are totally dependent on formulation development. Now-a-days formulation development is done by following QbD (Quality by Design).The aim of present study is to formulate Metformin HCl sustained release (SR) and Glimepiride immediate release (IR) bilayer tablet by different concentration of Hydroxypropyl methyl cellulose (HPMC) HPMC E-15and HPMC K4M to control the release pattern. The sustained release layer of Metformin HCL was prepared by using different grades of HPMC like, HPMC K-15, HPMC K-4 along with other excipients by direct compression technique. The immediate release layer of Glimepiride was prepared by Povidone, Crospovidone and by direct compression technique. The powders were evaluated for their flow properties and the finished tablets were evaluated for their physical parameters. Bi-layered tablet were characterized by FT-IR and in vitro dissolution studies. The drug release study of Bi-layered tablet was evaluated using USP-II paddle type dissolution apparatus. From the 5 batches F5 batch showed good release behaviors 95.61% of drug is released over 20 hours. Total 5 trial batches of each drug have been manufactured to optimize and develop a robust and stable formulation.