Abstract:
The study compared the disintegration and dissolution time of the antipsychotic drug, chlorpromazine hydrochloride (CPZH) tablet in the presence of simulated intestinal fluid (SIF), Simulated Gastric Fluid (SGF) and food modified SIF and SGF. Various quality control parameters including weight uniformity, tablet hardness, disintegration, friability and assay were assessed. SGF and SIF were employed as disintegration and dissolution media and compared with a food (1.3 ml full cream unsweetened evaporated milk, 2.67mg soluble starch) modified SIF and SGF (FMSIF and FMSGF) at 37 ± 0.5°C. The product assessed complied with the official specification for uniformity of weight friability and assay. The disintegration test showed significantly higher disintegration time for SIF and SGF (3.7 and 6.5 min) compared to the FMSIF and FMSGF (2.9 and 4.9s) (p< 0.05) but a significantly lower percentage drug release at 45 min in the SIF and SGF (52% and 43%) than the FMSIF and FMSGF (52% and 60%) (P< 0.05). The dosing condition of CPZH tablet should preferably be after meals to optimize drug release and subsequent absorption.

Keywords: Chlorpromazine, Modified SGF, Modified SIF.