Formulation development and optimization of taste masked generic fast dissolving zinc sulphate tablets

Abstract

Zinc sulphate tablets are indicated for the management of diarrhoea in children regardless of the cause. In Tanzania, there is only one pharmaceutical industry manufacturing zinc sulphate tablets and only 44% of children in need of zinc
sulphate tablets get access to them. Fast-disintegrating tablets of zinc sulphate were prepared by direct-compression method after incorporating the superdisintegrant polyvinyl pyrollidine cross-linked. Different types of experiments and evaluation parameters for tablets were assessed. Design expert software version 7 was used to optimize the formulation. Tablets containing polyvinyl pyrollidine cross-linked showed excellent disintegration time, friability and hardness compared to formulations containing other superdisintegrants. Tablets with 30mg/60mg sodium saccharin/strawberry had a palatable taste. Assay was within 95% to 105%, disintegration time was less than 60 seconds, and hardness was between 3.0 kg/cm² to 4.0 kg/cm², which comply with official US Pharmacopeia requirements. Therefore, a taste masked generic formulation of 20 mg zinc sulphate fast dissolving tablets with accurate dose and palatable taste was successfully developed and optimized.

Keywords: Zinc sulphate monohydrate, Fast disintegrating tablets, Disintegration time