Stability studies of the optimized oral metoclopramide hydrochloride tablet formulations prepared for IVIVC studies

Abstract

To examine the influence of environmental factors on the quality of a drug product over time, in order to recommend storage conditions and establish shelf life for the product, the accelerated stability studies for optimized formulations (Immediate Release- F2, Intermediate Release-F10 and Slow Release-F18), prepared for IVIVC Study, were carried out for a period of six months using ICH guidelines (at 40±2 ^oC and 75±5% RH). All the formulations were tested for disintegration test, % drug content and % drug release over the entire period of testing. Observations showed no degradation of the drug throughout the six months periods as % content uniformity of the three optimized immediate, intermediate and slow release formulations at one, three and six month was found within the limits. Moreover the results of drug release profiles at pH 1.2, 4.5, 6.8 and distilled water was also remained unaffected throughout the test period under elevated conditions when the trial formulations were compared with those stored in refrigerator. Shelf lives were calculated by software R Gui and were found to be 24, 14 and 20 months for IR (F2), IntR (F10) and SR (F18) formulations respectively. These stable novel optimized formulations will then be used for In Vitro In Vivo Correlation (IVIVC) studies of Metoclopramide HCl. No such stability studies of three formulations of Metoclopramide HCl with varying release rates are conducted before.