Formulation, Development, Characterization and Solubility Enhancement of Amisulpride

Abstract

Background: Amisulpride (AMP) is a drug that is poorly water-soluble and is typically characterized by high molecular weights, significant log P values, and low bioavailability. Poor water solubility of a drug is caused by strong intermolecular interaction and a drug's affinity for a lipid environment (lipophilicity).  Objective: The current study aims to improve Amisulpride's (AMP) oral bioavailability and solubility by developing a complex with 2-hydroxypropyl                             β-cyclodextrin (HP-β-CDT).  Method: This study describes solubility of AMP with β-CDT and HP-β-CDT. Prepared inclusion complex of AMP and HP-β-CDT by different techniques like physical mixture, kneading and lyophilization.  Result: A notable improvement in AMP's solubility was obtained with an optimized inclusion complex. The result of FT-IR, DSC and XRD confirms the complex between AMP and HP-β-CDT. The physical mixture, kneading and lyophilization technique, the kneading method is most successful in producing an inclusion complex. Conclusion: The 1.3 ratio gives the best drug content and dissolution profile.