OPTIMISED FORMULATION OF METOCLOPRAMIDE ORALLY DISINTEGRATING TABLET

Orally disintegrating tablet (ODT) was developed to solve the difficulty of swallowing conventional tablet for paediatric and geriatric patients. In administration of ODT, tablets are placed on the tongue in oral cavity and it will disintegrate rapidly in less than 60 seconds. The solid tapai extract (STE) has sweet taste, is rather sour and slightly soluble when it is put on the tongue. This is the reason why it has potential as a natural excipient in ODT. The objective of the study was to characterise STE as excipient and to use STE as excipient in the formulation of ODT by lyophilisation method. The ingredients were glutinous rice (Oryza sativa L. var. Glutinous) used to form tapai and the liquid extract of tapai which was used to make STE. STE was used as excipient by combining STE with dextrose and avicel. Metoclopramide HCl was used as a drug model. The design of formula used the simplex lattice design (SLD) model with a three components mixture: STE, dextrose and avicel as excipients. The parameters of lyophilised ODT (LODT) were hardness and friability, wetting time, disintegrating time and dissolution rate. The results showed STE can be used as filler and binder for LODT. STE could also function as disintegrant and formed porosity in the lyophilised method. Based on equation and contour plot of superimposed method, a formula consisting of STE (24.18 mg), dextrose (19.71 mg) and avicel (96.11 mg) was the optimum formula of LODT.