Abstract

FORMULATION AND EVALUATION OF PELLETS LOADED WITH DILTIAZEM HYDROCHLORIDE FOR SUSTAINED RELEASE

Rashmitha N. M.*, Somashekar C. N., Shravya Lakshmi S. and T. Tamizh Mani

Abstract

The objective of this study was to prepare and evaluate Diltiazem hydrochloride loaded pellets for sustained release by using Extrusion- Spheronization Method. The different formulations were prepared using MCC as extrusion aid, CMC as a binder and demineralized water is used as a granulating agent. The mean particle size of the drug loaded pellets was in the range 1026 - 1061μm. SEM photographs and calculated sphericity factor confirmed that the prepared formulations were spherical in nature. In vitro drug release studied in pH 6.8 phosphate buffer.F5 formulation showed the better drug release of 88.1%. F5 formulation was the optimized formulation. The drug content and entrapment efficiency was in the range of 92.97 – 97.12% and 89.17 – 95.27% respectively. The compatibility between drug and polymers in the drug loaded pellets was confirmed by DSC and FTIR studies. The stability studies were carried out for a period of 90 days at 40±2 °C and 75±5% RH. Stability studies indicated that pellets are stable.

Keywords: Diltiazem hydrochloride, Pellets, Extrusion-spheronization method, In vitro study.