Innovative Multi-source Cetirizine Dissolution Profile Study

Abstract

Introduction: The scarce study among drugs and their referents according to behavior during their dissolution process prevents patients from accessibility to effective, safe, low-cost drugs with adequate therapeutic effect.

Objective: To evaluate dissolution profiles of multi-source and innovative cetirizine 10 mg tablets marketed in Peru and Brazil in order to establish the interchangeability of the multi-source drug in relation to the reference drug.

Methods: The research was carried out with tablets from laboratories marketing their formulations in Peru (A, B, C, D) and Brazil (E, F), which were compared with an innovator product. Twelve units of each presentation collected from certified pharmaceutical establishments were used, and their lot number and expiration date were recorded. It was verified that the equipment and volumetric material were qualified and calibrated. Then, a calibration curve was prepared from a stock solution. Ten standard solutions with increasing concentrations were obtained, which were read in a spectrophotometer at 231nm. The working conditions were established according to the American Pharmacopoeia 44 and water was used as the medium, in a volume of 900 mL, 50 rpm, temperature 37 °C and sampling times at 5, 10, 15, 20 and 30 min. At the end, dissolutionprofiles were evaluated through the similarity factor and percentage dissolution efficiency.

Results: Formulations A, B, D, E and F at 30 min presented higher dissolved percentages (80 %), but when calculating percent dissolution efficiency and similarity factor, only B and E complied with values established by international organizations to be considered similar.

Conclusions: The dissolution profiles of a Peruvian and a Brazilian formulation are interchangeable with the innovator, representing effective, safe and quality pharmaceutical alternatives.