Silymarin loaded floating polymer(s) microspheres: characterization, in-vitro/in-vivo evaluation

Pharm Dev Technol. 2020 Nov;25(9):1081-1089. doi: 10.1080/10837450.2020.1795192. Epub 2020 Jul 27.

Abstract

Silymarin has a short half-life (4-6 hours) which leads to necessity of frequent administration. Besides, it suffers from intestinal degradation. Thus, our study aims to formulate encapsulated floating microspheres using different polymers as HPMC, EC and a blend of them. Emulsion solvent evaporation technique was applied for preparation of microspheres. Parameters considered during preparation are drug: polymer ratio and emulsifier concentration. Selected formulations were characterized by SEM and subjected for assessment by drug entrapment efficiency, buoyancy for 12 hr, in- vitro drug release, kinetics of release and stability. In-vivo bio-equivalence study was performed using albino rabbits. Formula F24 (treatment II) exhibited high % buoyancy (73.4), higher t90 (190.7 day), high Cmax (1021.3 ng/ml) and Tmax (6 h) with a significant difference between it and treatment I (Silymarin plus) after carrying out ANOVA study. Also formula F24 exhibited MRT (hr) equal 9.44 ± 0.03 and high relative bioavailability RB% (227%), which indicates promising microspheres that could be used for effective management of liver disease.

Keywords: Floating microspheres; bioavailability study; bioequivalence study; emulsion solvent evaporation; in-vitro release; silymarin drug; stability.

MeSH terms

  • Animals
  • Chemistry, Pharmaceutical / methods
  • Drug Delivery Systems / methods
  • Drug Liberation / drug effects
  • Emulsions / chemistry
  • Microspheres
  • Polymers / chemistry*
  • Rabbits
  • Silymarin / chemistry*

Substances

  • Emulsions
  • Polymers
  • Silymarin