Studies On Decisive Components In Osmotically Controlled Release Oral Delivery System Of Pregabalin

Abstract

Pregabalin is absorbed in the small intestine and proximal colon and poorly absorbed beyond hepatic flexure. In immediate release dosage form most of the drug gets eliminated from the body because of short half life and narrow absorption window. In conventional extended release dosage form beyond 6 hours would be wasted because the dosage form has travelled beyond the hepatic flexure. Osmotic drug delivery system with bigger size of dosage form (not to pass pyloric sphincter) is good choice to address the identified issues.

The present study aimed to design the formulation which retains in the stomach and release the drug. In the development of the formulation of Pregabalin Microcrystalline cellulose, Mannitol, Povidone, Colloidal silicone dioxide and magnesium stearate are used to form the tablets. To get the extended release action of the Pregabalin, Cellulose acetate and PEG are used as extended release coating component. Tablets were prepared by using wet granulation technology; blend and uncoated tablets were evaluated for different inprocess parameters. After extended release coating of the tablet it is further drilled for suitable orifice diameter to achieve the desired drug profile. Based on physical parameters and dissolution results of various trials of the product Formulation F9-330 was selected as optimized formulation. This particular batch has been kept on stability as per the ICH recommendations. Hence the extended drug release can be achieved by using OROS technology