FORMULATION DEVELOPMENT AND EVALUATION OF IMMEDIATE RELEASE DOSAGE FORMS OF ANTI-HYPERTENSIVE AGENT IN COMBINATION

Abstract

The aim of the present research was to formulate and develop immediate release dosage form combination for the treatment of hypertension. There were two drugs used of BCS class II and III in combination in this formulation. In this study two formulations were formulated, developed and evaluated. The two approaches used were; one was tablet and other was pellets. Tablets are considered as one of the most important route for administration of drug in case of immediate release formulation. Tablet as a dosage form offers a wide range of advantages as compared to other route of administration. Tablet is consider as first choice among all dosage forms because of its expediency of self administration, compactness and trouble-free manufacturing; low cost and on-invasive therapy etc. Immediate release formulation disintegrates rapidly subsequent to administration with improved rate of dissolution. In formulation of tablets wet granulation method was used to prepare the tablets by using different excipient lactose monohydrate, pregelatinized starch maleic Acid, iron oxide yellow, dried maize starch, Sodium steary fumarate and Magnesium stearate. Preformuation study was performed in order to check the compatibility of drug and excipient. Pre-compression and post compression parameter like bulk density, hardness and dissolution were performed to ensure that the formulation was of maintained standard and identical with the innovator produtct. The other method to formulate immediate release formulation was pellets. Pellets are multiparticulate dosage form which was formed by the agglomeration of fine powdered excipient and drugs together that leads to the formation of small free flowing spherical or semi spherical particles. This technique is called as pelletization process. Pellets are typically varied between 500-1500 μm in size for pharmaceutical applications. It is of great interest over other similar techniques due to its uniformity of dose, less susceptibility of dose dumping, less friability etc. The formulation of pellets was done by using extruder spheronized as technique with the help of excipents like microcrystalline cellulose, polyvinylpyrolidone and crosspovidone. In this study the process parameter like speed of spheronizer and formulation parameter like quantity of disintegrating agent were optimized. The evaluation of pellets was done on the bases of friability, shape and dissolution.