Abstract

Mahesh Kumar T.*, Bala Parameshwari M.

ABSTRACT

The present work aimed to formulate tadalafil immediate release oral tablets using nano-cocrystals for enhanced drug dissolution rate with necessary pharmaceutical quality attributes, and ensure that the process of manufacturing is easily scalable.  Tadalafil drug belongs to the BCS class II category of highly insoluble and highly permeable; its nano-cocrystals possess improved solubility, were used to formulate into tablets by the direct compression technique. Compatibility between tadalafil with other formulation excipients of tablet was established by FT-IR spectroscopy. The powder blends of tadalafil nano-cocrystals prepared with selected excipients were evaluated for precompression parameters, and the tablets prepared were evaluated for various physical properties, drug assay, disintegration and in-vitro drug release. Selected formulations were subjected to stability studies as per ICH guidelines. The precompression parameters revealed that the flow of the blend prepared was satisfactory for its direct compression process. Complete drug release in a short time was achieved when using the tadalafil nano-cocrystals in the formulation compared to the tadalafil plain drug formulation. It was concluded that in-vitro drug release was enhanced when formulating the nano-cocrystals form of insoluble drug tadalafil in a directly compressible tablet dosage form, and hence the systemic absorption of the drug in biological medium will be higher, which leads to increased bioavailability.