Abstract

FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF LOPERAMIDE

Nirmala Dasari*, Manoranjani Addanki and Sudhakar Muvva

ABSTRACT

Loperamide hydrochloride is the drug of choice for diarrhoea. It undergoes first pass metabolism and the resulting bioavailability is very low. Hence, there is a need to develop fast dissolving tablets, which disintegrate in matter of seconds in the oral cavity. The main objective of present work was formulation and evaluation of fast dissolving tablets of Loperamide by direct compression method using superdisintegrants like sodium statch glycolate, crosscarmellose sodium, prepared tablets evaluated for drug and excipients compatability studies (FTIR), precompression parameters, post compression parameters, wetting time, in vitro drug release studies and stability studies. FTIR studies revealed there is no physical and chemical interaction between drug and excipients. Precompression parameters were satisfactory suitable for formulation development. Post compression parameters were within the limits and satisfactory. Wetting time of the all the formulations were found to be in the range
of 143 to 158 sec. Among all the formulations F7 showed 95% of drug release, considered as best formulation. There was no significant change in physical and chemical properties of the tablets of formulation F7 after 90 days, parameters like % drug release and assay values at various conditions (at 400C/ 75% RH) as per ICH guidelines quantified at various time intervals.

Keywords: Fast dissolving tablets, Direct compression, Loperamide, Cross carmellose sodium, Sodium starch glycolate.