The purpose of this research was to formulation and evaluation of oral disintegrating tablets of haloperidol - hydroxypropyl β-cyclodextrin (HPβCD) complex. Haloperidol is used for treatment of severe nausea and emesis in post-operative and palliative care for radiation therapy and chemotherapy, also in acute delirium, anxiety, depression, hyperactivity, psychosis, schizophrenia. Phase solubility study indicated formation of 1:1 molar ratio of inclusion complex system of haloperidol with HPβCD. Complexes were prepared by freeze drying method. Complex may improve solubility, reduce irritation, protect from light and mask the taste of haloperidol. Prepared complexes were evaluated for DSC, FTIR, drug content and in-vitro release study. Oral disintegrating tablets (ODTs) were developed from haloperidol inclusion complex containing superdisintegrants by direct compression method. Different formulations were prepared by varying the concentration of sodium starch glycolate (SSG) and micro crystalline cellulose (MCC) PH102. The directly compressible powder was evaluated for precompression parameters. Prepared tablets were evaluated for postcompression parameters. Dissolution studies were performed in SSF pH 6.8 and 0.1 N HCl (pH 1.2). The optimized batch was compared with the control (C1, C2) and marketed formulation, also charged for stability study as per ICH guidelines. In 32 full factorial design, Quadratic model was suggested, contour and 3D Graph was generated. By using Overlay plot, batch was optimized. F9 batch prepared with 5% SSG and 70% MCC PH102 decrease disintegration time and Wetting time i.e. (8±1) sec and 12±1.52 sec respectively.
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