Formulation and Invitro Evaluation of Sustained Release Tablets of Pregabalin: https://doi.org/10.54037/WJPS.2022.100301

Sham Shad Begum; G.S. Sharma; B. Rama; L. Jyothi Rani; B. Rajkamal

Authors

Sham Shad Begum Department of Pharmaceutics, Malla Reddy Institute of Pharmaceutical Sciences, JNTU, Hyderabad, India
G.S. Sharma Department of Pharmaceutics, Malla Reddy Institute of Pharmaceutical Sciences, JNTU, Hyderabad, India
B. Rama Department of Pharmaceutics, Malla Reddy Institute of Pharmaceutical Sciences, JNTU, Hyderabad, India
L. Jyothi Rani Department of Pharmaceutics, Malla Reddy Institute of Pharmaceutical Sciences, JNTU, Hyderabad, India
B. Rajkamal Department of Pharmaceutics, Malla Reddy Institute of Pharmaceutical Sciences, JNTU, Hyderabad, India

Keywords:

HPMC K4M, HPMC K15M, Di calcium phosphate, Metalose 60SH-50, Mg. stearate

Abstract

The main aim of proposed work was to develop Pregabalin sustained release matrix tablets. Sustained release formulation is the drug delivery system that is designed to achieve a prolonged therapeutic effect by continuously releasing medication over an extended period of time after administration of single dose. The sustained release tablets were prepared by direct compression method using HydroxyPropylMethylCellulose (HPMC K4M, K15M), Dicalcium phosphate, Metalose (60SH-50). Tablets blends were evaluated for loose bulk density, tapped bulk density, compressibility index and angle of repose, shows satisfactory results. The compressed tablets were then evaluated for various physical tests like diameter, thickness, uniformity of weight, hardness, friability, and drug content. The results of all these tests were found to be satisfactory. The Invitro dissolution studies was carried out in 0.1N HCl (pH 1.2) for first 2 hours and remaining 10 hours was carried out in Phosphate buffer (pH 6.8) by using paddle method as dissolution medium. F1 to F12 formulations were prepared by using direct compression method. Among all the formulations, F12 formulation was comparatively releases 100% drug over 12hrs. F12 performed similar to the Marketed product therapeutically. Kinetic models were applied to the Optimized formulation and observed that formulation (F12) followed First order kinetic model and it was complied with (reference sample). The best linearity was found in Korsmeyer-Peppas model (where n=0.583 is release exponent) indicating non-Fickian mechanism of drug release. FTIR compatibility studies reveal no incompatibility in the formulations.