European Journal of Molecular & Clinical Medicine

Abstract

Objective: Aim of this study is to compare the in-vitro multimedia dissolution and in-vivo bio availability of mouth dissolving film of Promethazine hydrochloride with marketed tablet formulation.
Method: Solvent casting method was used to prepare the mouth dissolving film. The prepared film was characterized for average weight, thickness, drug contents, mechanical properties and disintegration time. Multimedia dissolution comparison of the film was performed in 0.01N Hydrochloric acid, pH 4.5 acetate buffer and pH 6.8 phosphate buffer to calculate the f2 values in each media. Furthermore, the film was evaluated for bioavailability comparison with the marketed tablet formulation Phenergen-10 in newzealand male albino rabbits.
Results: Value of similarity factor (f2 value) was found more than 50%, in all three dissolution media. There was no statistically significant difference found between the pharmacokinetics parameters; Cmax, AUC_0-t and AUC_0-∞. The 90% CI values for the mean ratios (test/reference) of C_max (112.245 ng/ml), AUC_0-t (106.451 ng/ml.hr) and AUC_0-∞ (104.067 ng/ml.hr) suggested that the test formulations is bio-equivalent to the reference tablets.
Conclusion: These finding revealed that the mouth dissolving film of promethazine hydrochloride could be the promising option of the conventional tablet formulation for controlling the motion sickness in elderly and giardiac population.
Keywords: Multimedia Dissolution, Mouth dissolving film, Bio-equivalence study, Promethazine hydrochloride