Development And Evaluation Of Dry Syrup Of Class II Drug Using Solid Dispersion Approach

Abstract

Solubility and dissolution is the rate limiting step for absorption and bioavailability of BCS class II drugs. Simvastatin (SMV) has been chosen as the model medication in this work in order to develop and evaluate the dry syrup utilizing a solid dispersion (S.D.) method. Using a solvent evaporation technique, this study created solid dispersions of simvastatin using sugar-based carriers such as xylitol, sorbitol, lactulose, and one non-sugar carrier called soluplus. Various suspending agents were utilized to transform optimized Simvastatin S.D.s into dry syrup formulations. The dry syrup formulations were assessed for flow characteristics, drug content, and reconstitution time. The reconstituted syrup underwent tests for viscosity, dispersibility, pH, sedimentation volume, degree of flocculation, drug release studies, and accelerated stability testing, scanning electron microscopy were used to characterize the dry syrup. SMV:Lactulose (1:1.5) selected as optimized SD and incorporated into dry syrup. Good flow properties were demonstrated by SMV dry syrup formulations, which are crucial for filling the container. The formulations were found to take between 3.2 and 5.2 minutes for reconstitution; good redispersibility (8 to 15 strokes); their pH ranged from 6.3 to 6.6; their sedimentation volume was determined to be between 0.45-0.95; and over the course of an hour, all of the formulations demonstrated 99% drug release. On the other hand, the drug release from the marketed tablet dosage forms was only 56% after an hour. The optimized formulation (F9) subjected for accelerated stability testing by following the ICH stability guidelines. From the results obtained it is concluded that formulation (F9) is an optimized formulation with good stability and following first order kinetics of drug release.