Development and evaluation of orodispersible sustained release formulation of amisulpride–γ-cyclodextrin inclusion complex

Amisulpride (AMI) is an atypical antipsychotic having poor aqueous solubility and poor oral bioavailability. Inclusion complex between AMI and gamma cyclodextrin (γ-CD) was prepared by kneading method using 1:1 stoichiometry. Solubility of AMI was enhanced by 3.74 times after inclusion complex formation. Amisulpride–γ-cyclodextrin inclusion complex was characterized by FTIR, DSC and XRD techniques. Further sustained release granules of Amisulpride–γ-cyclodextrin inclusion complex (CDSR) were prepared by treating complex with molten stearic acid. Drug release from CDSR granules was sustained up to 12 h with 100 % stearic acid proportion. The integrity of AMI–γ-CD inclusion complex in lipid phase was assessed by XRD study. Finally orodispersible tablets of CDSR granules (OD-CDSR) were prepared using Ac-Di-Sol and microcrystalline cellulose. Disintegration time was assessed by both pharmacopoeial and modified method. Optimized formulation was rapidly disintegrated within 25 s. Thus solubility enhancement and sustained release of AMI was achieved by orodispersion of CDSR granules for improvement of patient compliance.