Development and Evaluation of Novel Formulations for Poorly Soluble Drugs

Abstract

Delivering drugs across the Blood-Brain Barrier is one of the promising applications of nanotechnology in clinical neuroscience. Nanoparticles could potentially carry out newlinemultiple tasks in a predefined sequence, which is very important in the delivery of drugs across the Blood-Brain Barrier. Risperidone PLGA nanoparticles were prepared by using the Solvent Displacement Method or Nanoprecipitation Technique and by using newlinedifferent concentrations of drug-to-excipient ratio, PLGA [75:25], Poloxamer-188, acetone, water, and manufacturing attributes. The nanoparticle formulations were characterized for particle size, polydispersity index (PDI), Zeta-potential, Entrapment Efficiency, Differential Scanning Calorimetry (DSC), X-Ray Diffraction (X-RD), and Scanning Electron Microscopy (SEM) studies. Optimization was performed by varying parameters like an organic solvent, drug-to-polymer ratio, types of surfactants, and concentration of surfactant taken into consideration. The particle size of optimized batches was found in the range of 131 to 133 nm, with the entrapment efficiency found in the range of 88.28 to 89.87%. Entrapment efficiency was carried out by using the Sephadex G-25 column. In vitro, drug release studies of Risperidone from nanoparticles were determined using the Dialysis bag diffusion technique at regular intervals throughout 72hrs. The lyophilized nanoparticles were blended with excipients and lubricant and compressed into tablets. The final conventional dosage form was further analyzed for IPQC parameters, assay, dissolution, and related impurities study. Stability studies of Risperidone Modified Release Tablets 25mg in Alu-Alu blister packs in Accelerated, Intermediate, and Long Term condition concluded the stability of dosage form as per ICH guidelines. The Minitab 19 mathematical data and extrapolation Abstract confirms the correctness of the parameters involved in the studies. Over the last ten years, the number of poorly soluble drugs has steadily increased.