Formulation and evaluation of fast disintegrating tablet containing capecitabine for dysphagia patients

Abstract

Capecitabine (CAP), an anticancer agent used for breast and colorectal cancer has high and variable dosage regimen based on body surface area. Due to high dose, around 3 to 7 tablets are swallowed each time. Dysphagic patients experience difficulty in swallowing the conventional tablets and consequently do not take medications as prescribed. Hence the aim of the present research was to overcome the swallowing problem by developing fast disintegrating tablet (FDT) which disintegrates rapidly when placed on the tongue. FDT was prepared and optimized by wet granulation technique incorporating various superdisintegrants and other excipients. The granules prepared showed good flow and compressible property; hence tablets produced were of uniform weight with acceptable weight variation. Drug-excipient compatibility was confirmed by Fourier transform infrared spectroscopy (FTIR) and Differential scanning calorimeter (DSC) studies. FDT retained its crystalline nature after tableting which was revealed by X-ray Diffraction studies. The disintegration time (DT) of the optimized formulation F1 (150 mg strength) and F2 (500 mg) showed rapid DT of 9 and 14 s when carried out using 1 mL purified water. FDTs demonstrated excellent in vitro dissolution results. Stability studies results were also found satisfactory when stored at 25 ± 2°C / 60 ± 5% RH. Hence it can be concluded that CAP FDT disintegrates rapidly in seconds with excellent dissolution profile, thus providing convenience of administration, patient compliance and safety to overcome swallowing problem for dysphagia patients.