A Comparative In-Vitro Dissolution And In-Vivo Bioavailability Study Of Mouth Dissolving Film Of Promethazine Hydrochloride Against The Marketed Tablet Formulation

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Jyoti Vardhan Jaiswal , Rajendra Pal Singh Rathore1, Mridul Ranajan, Piumitali Bera

Abstract

Objective: Aim of this study is to compare the in-vitro multimedia dissolution and in-vivo bioavailability 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 New Zealand 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, AUC0-t and AUC0-∞. The 90% CI values for the mean ratios (test/reference) of Cmax (112.245 ng/ml), AUC0-t (106.451 ng/ml.hr) and AUC0-∞ (104.067 ng/ml.hr) suggested that the test formulation is bio-equivalent to the reference tablets.


Conclusion: These findings 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.

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