Development and evaluation of solid dispersion based rapid disintegrating tablets of poorly water-soluble anti-diabetic drug

Abstract

Glimepiride is an effective oral hypoglycemic agent that lowers the glucose level of blood by stimulating insulin release from beta cells of the pancreas. However, the poor aqueous solubility (i.e., <0.004 mg/ml) and wettability of drug pose hurdles in the formulation of drug delivery vehicles. In this research work, we have attempted to develop rapid disintegrating tablets (RDT) of glimepiride solid dispersion. Gelucire 50/13, PEG 4000 and PEG 6000 were employed as polymeric carriers to formulate solid dispersions by kneading and spray drying techniques and were characterized by FTIR, DSC, saturation solubility analysis, drug content, and in vitro dissolution studies.From the obtained data, it was exhibited that the improvement in solubility and dissolution was highest for 1:3 spray-dried solid dispersion of glimepiride with gelucire 50/13 (batch A6). The RDT was prepared using the optimized batch of solid dispersion and was tested for hardness, thickness, drug content, weight variation, friability, disintegration time, and in vitro dissolution studies. The optimized batch (F7-A6) showed maximum cumulative drug release within the minimum period. It also exhibited a higher dissolution profile in comparison to the marketed tablet. From the stability studies carried out on RDT formulation, it was revealed that the tested tablets were quite stable. Hence, the rapid disintegrating tablet of the poorly water-soluble drug, glimepiride, could be a promising strategy for the development of better anti-diabetic drug delivery carriers.