An evaluation of the effect of aging on the quality attributes of orodispersible tablets prepared by the direct compression technique.

Abstract

Background: The presented study aimed to evaluate the effect of aging on the quality attributes of ODTs.

Experimental: ODTs prepared in one of our previous studies, packed in standard blister packing, were stored at ambient conditions in a laboratory (protected from direct sunlight) for 5 years and evaluated for their quality attributes, including physical parameters, mechanical strength (crushing strength, specific crushing strength, tensile strength, and friability), disintegration behavior (in vitro disintegration time, oral disintegration time, and wetting time), assay and dissolution rates. Drug content of all the samples was determined by HPLC.

Results: Physically, the ODTs were oval (10 mm), shallow, and convex with a bisection line, and their compression weight was 200 mg/tablet. With the passage of time, the moisture content of the ODTs increased from 2.4 ± 0.39% to 3.48 ± 0.62%. After 5 years, the drug content decreased to 92.38 ± 0.93%.

Discussion: Initially, there was an increase in the crushing strength of the ODTs (up to 3 years), and then it gradually decreased. At the time of preparation, disintegration time of the ODTs was 53 s, which gradually increased up to 89 s, at the 4th year. After completion of the study, it slightly decreased to 85 s. The dissolution rate of domperidone from the ODTs remained unaffected by aging. The FTIR spectra of the ODTs showed insignificant cahnges, indicating absence of degradation during the study period.

Conclusion: ODTs remained stable for five years and insignificant changes were observed in their quality attributes.