Lurasidone hydrochloride-loaded microparticle-based long-acting injectable: formulation optimisation, characterisation, and payload release kinetics-a proof of concept study.

Lurasidone hydrochloride is a promising antipsychotic agent. The currently marketed formulation (Latuda®) of lurasidone hydrochloride exhibits extremely poor bioavailability and requires daily dosing. Current research focuses on the development and optimisation of a lurasidone hydrochloride-loaded poly(lactic-co-glycolic acid) microparticle-based long-acting depot formulation. The optimised batch of microparticles showed 32.81 ± 1.46 µm particle size, 95.74 ± 3.19% an entrapment efficiency, and a drug loading of 27.68 ± 0.95%. The morphological examination showed the buckling effect on the surface of microparticles, resembling the appearance of a golf ball, and DSC revealed amorphisation and successful encapsulation of lurasidone hydrochloride. The in vitro release study was performed for real-time and accelerated conditions, which showed the triphasic drug release pattern and followed the Hixon-Crowell release kinetic model. The real-time study showed 80.26 ± 3.84% drug release within 90 days. Overall, the results of this research work furnished a strong basis for further development of lurasidone hydrochloride microparticle-based long-acting injectables at a large scale.