Abstract:
Assessment of the stability of pharmaceutical formulations is always crutial in pharmaceutical product development. Stability could be viewed from the degradation of the active ingredients or a change in the physicochemical properties of the formulations. The objective of this study was to evaluate the effect of storage on the physicochemical characteristics of sorgum starch-based folic acid tablet formulations vis-a-vis tablets prepared with maize starch BP, a standard tablet binder. The folic acid tablets were prepared by wet granulation technique using sorgum and maize starches, and evaluated for physical properties, such as weight variation, thickness, hardness, friability, disintegration time, drug content and in vitro drug release study. The formulations were subjected to stability studies as per ICH guidelines at different temperatures and humidity conditions. Results indicated that the folic acid tablets did not show any appreciable changes with respect to hardness, disintegration time, drug content and dissolution profiles. In addition, results revealed that the stability of folic acid tablets formulated with the local sorgum starch as binder compared favourably with those formulated with imported maize starch B.P. when stored under various conditions of temperature and humidity over a period of one year. This study has shown that proper storage conditions are very necessary for folic acid tablets to have long shelf life, as high temperature and high humidity would negatively affect the stability of these tablets.

Keywords: Sorgum, Folic Acid Tablets, Physicochemical Properties, Maize, Stability, Starch.