EVALUATION OF SPRAY AND FREEZE DRIED EXCIPIENT BASES CONTAINING DISINTEGRATION ACCELERATORS FOR THE FORMULATION OF METOCLOPRAMIDE ORALLY DISINTEGRATING TABLETS

Orally disintegrating tablets (ODT) are gaining attractiveness over conventional tablets specially for patients having difficulty in swallowing such as pediatric, geriatric, bedridden and disable patients. ODT technologies render the tablets disintegrate in the mouth without chewing or additional water intake. So far there have been many patents for ODT, but only few publications are dealing with this dosage form. The aim of the present study was to formulate metoclopramide in ODT with sufficient mechanical strength and fast disintegration from bases prepared by both spray (SD) and freeze drying (FD) techniques. Different disintegration accelerators (DA) were utilized to prepare the proper ODT using various super-disintegrants (Ac-Di-Sol, Kollidon and sodium starch glycolate), a volatilizing solvent (ethanol) and an amino acid (glycine). Metoclopramide, an antiemetic medication, was used as a model drug in the formulated ODT. It was noted that the disintegration of ODT depends on utilization of DA in both SD and FD techniques to prepare tablet bases for ODT and so many other factors such as drying process, type of DA, and the addition of DA before or after the drying processes. The good disintegration property of the prepared tablets was related to the excellent wettability of the ingredients after being subjected to the drying processes. Results also showed that the addition of DA to the tablet bases before drying process results in lengthening of the disintegration time in comparison to their addition to the tablet bases after the drying process. These findings could be utilized for many drugs and they may be considered versatile in the applications. Also, the disintegration of the ODT in the buccal cavity may favor fast absorption via the mucus membrane in the oral cavity.