Abstract

FORMULATION AND EVALUATION OF ORAL DISINTEGRATING TABLETS OF MONTELUKAST SODIUM AND DESLORATADINE

Y. Siva Naga Pavani*, Sasikanth Kothamasu, Suryakanta Swain, P. Prem Kumar and Manohar Babu S.

ABSTRACT

Aim of the present study is “Formulation and evaluation of oral disintegrating tablets of Montelukast sodium and Desloratadine”. ODTs were prepared by direct compression method and by using Crospovidone, Croscarmellose sodium and sodium starch glycollate as super disintegrants which disintegrates in matter of seconds in the oral cavity, thereby reducing the time of onset of pharmacological action and to reduce the first pass metabolism. Magnesium stearate was used as a lubricant, aspartame as sweetener and orange flavour is used to improve mouth feel. The drug polymer compatibility was confirmed by FTIR studies. The results obtained by FTIR studies revealed that there was no chemical interaction between drug and excipients. Direct compression method was used to formulate the tablets, because of its cost effectiveness and to reduced number of manufacturing steps. The pre compression parameters like angle of repose, Cars index, Hausner’s ratio, tapped and bulk density were performed and were found to be within the limits. The post compression parameters were also studied including the Weight variation, Hardness, friability, Thickness, wetting time, In vitro disintegration and the water absorption ratio and the values were found to be within the limits. In-vitro dissolution studies showed that formulations F4, F10, F11 showed better dissolution of Desloratidine and Montelukast when compared with marketed formulation and among them F11 was found to be better formulation when compared to others. Based on the formulation development and results, F11 formulation was considered as the desired formulation which contains crospovidone 4 % as a super disintegrants.

Keywords: Oral Disintegrating Tablets (ODTs), Montelukast sodium and Desloratadine.