Application of Arrhenius Equation and Plackett-Burman Design to Ascorbic Acid Syrup Development
Keywords:
Arrhenius equation, Plackett-Burman design, Ascorbic acid syrupAbstract
Stability testing and drug-excipients compatibility of pharmaceutical dosage forms are necessary to perform during the early stages of product development. The aim of this study was to apply Arrhenius equation and Plackett-Burman design for stability testing and drug-excipients compatibility of formulations, respectively. The stability of ascorbic acid in syrup was examined using an accelerated stability testing according to the Arrhenius equation. The formulations were stored at room temperature and over the temperature range of 40-70°C. A linear regression line was obtained from Arrhenius plot of the reaction rate (k) against reciprocal of degree kelvin. The heat of activation was found to be 17.96 kcal/mole. Plackett-Burman experimental design was used to investigate the compatibility of ascorbic acid with various syrup excipients. It was found that glycerin (5%v/v) exerted a significant stabilizing effect on ascorbic acid, whereas sugar cane syrup (33.3%v/v) had destabilizing effect. The other excipients appeared to be no significant effect on ascorbic acid stability. The study demonstrated that Arrhenius equation would be useful for the prediction of product stability and the stabilizing or destabilizing effects of excipients could be identified by Plackett-Burman design.
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