Formulation and Evaluation of Sustained-release Matrix Tablets of Withania coagulans Extract for Antidiabetic Activity

Abstract

Herbal phytomedicines provide alternative approaches to conventional allopathic therapies, which are often expensive and associated with adverse effects. Withania coagulans fruits have been traditionally recognized for their antidiabetic properties. The study aimed to develop and optimize sustained-release matrix tablets of Withania coagulans extract and evaluate their in vitro antidiabetic potential containing freeze-dried extract of Withania coagulans Linn. The tablets were formulated by wet granulation method using HPMC K100 as a polymer and starch as a binder. Ethanolic extraction of Withania coagulans was performed using a Soxhlet apparatus, and phytochemical screening revealed the presence of carbohydrates, glycosides, alkaloids, flavonoids, proteins, and steroids. In vitro antidiabetic activity was assessed by glucose uptake in yeast cell model assay at various concentrations, showing a dose-dependent increase. The ethanolic extract exhibited 64.24% glucose uptake compared to 73.3 % for the standard drug Metformin at 500 µg/mL. Sustained release tablets were compressed using a 16-station rotary press (13 mm die) at 6–8 ton compression force. The prepared formulations were evaluated for hardness, thickness, weight variation, friability, disintegration, and drug content, all of which were within acceptable limits. In vitro dissolution studies indicated that formulation F2 containing 100 mg of HPMC K100 achieved 94 % drug release over 12 hours, demonstrating effective sustained release characteristics. The study concludes that Withania coagulans fruits possess significant in vitro antidiabetic potential and that sustained release matrix tablets of its freeze-dried extract can be successfully developed and evaluated as per Indian Pharmacopoeia standards.