Formulation and Evaluation of Diltiazem Hydrochloride Sustained Release Matrix Tablets

Abstract

Tablets are the most popular and versatile formulations with wide acceptance when compared to other dosage forms due to ease of administration, storage and transport. Diltiazem HCl is a calcium channel blocker widely used for its peripheral and vasodilator properties in the treatment of hypertension and angina. The objective of the present study is to prepare and characterize novel sustained release tablets of freely water soluble drug Diltiazem HCl using hydrophobic (Ethocel) and hydrophilic (HPMCK100M, HPC) polymeric matrix systems. Dicalicum phosphate and Avicel (pH 102) are used as diluents, Aerosil, talc, and magnesium stearate are used as glidants and lubricant by direct compression technique which is cost effective, and reliable method. Sustained release tablets are advantageous because of its once/twice daily administration, for patient compliance, reduction of side effects, and continuous delivery of drug into systemic circulation. Drug-excipients compatibility studies were studied by FT-IR. The pre and post compression parameters were evaluated for the prepared formulation and further compared with the marketed formulation. Based on dissolution studies, formulation F2 (HPC 30%) gave release up to 94.62% at the end of 12 h which was considered as optimized formulation. The dissolution data were fitted into various kinetic models. First order and Korsmeyer peppas plots were best fit for formulation F2. The release follows non-Fickian diffusion transport mechanism which shows both diffusion and erosion during drug release for the matrix tablet. The accelerated stability studies were done for three months to the optimized formulation as per ICH guidelines.

Keywords: Calcium channel blocker, matrix systems, Diltiazem hydrochloride, hydroxy propyl cellulose, and novel sustained release tablets

Cite this Article

Swarnalatha Metta, Rajesh Kaza, Selvaraj B, Sandhya Deepa E, Selvaraj. Formulation and Evaluation of Diltiazem Hydrochloride Sustained Release Matrix Tablets. Research & Reviews: A Journal of Pharmaceutical Science. 2015; 6(2): 17–27p.