Formulation, Evaluation and Antioxidant activity of Caffeine Fast Melt Tablets

Abstract

The aim of this study was to investigate the effect of various Prosolv® co-processed excipients in the manufacture of different grades of fast melt tablets (FMTs). Caffeine was chosen as a model drug. Caffeine FMTs were prepared by direct compression using Prosolv® based excipients;Prosolv® SMCC 50, Prosolv® SMCC 90,Prosolv® SMCC HD90, Prosolv® ODT, Prosolv®Easytab Nutra,and Prosolv®Easytab SP. Caffeine FMTs were evaluated for weight, thickness, hardness, friability, wetting time (WT), in-vitro disintegration time, and in-vitro dissolutionstudies. The selected Caffeine FMT was compared with oral commercial tablets (Stay Awake Caffeine Alertness Aid®, Equate, USA) for their antioxidant activities and their impact on reproductive organs of male rats. All Caffeine FMTs were within the pharmacopeial limits for weight, and content. All formulae had acceptable friability percentage (<1%) except Prosolv® SMCC HD based formula. Prosolv® Easytab Nutra based formula showed superiority over Prosolv® Easytab SP and Prosolv® ODT regarding WT and DT. Furthermore, Prosolv® Easytab Nutra based formula gave comparablefunctionality to its analogous formulae based Prosolv® SMCC 50 and Prosolv® SMCC 90 with superior advantages regarding simplicity of manufacture and the potential minimizing of undesirable issuesas segregation by reducing the number of steps during production of tablets. The data concluded that the Prosolv® co-processed excipients are promising carriers for Caffeine FMT designed formodulating male reproductive hormone reproductive values and oxidative stress with having greaterbenefits of dosage form which, in turn, increase compliance.