Resumen

HERRERA-CALDERON, Oscar y GRANDE-ORTIZ, Miguel. Equivalencia terapéutica de tabletas de diazepam dispensadas en la ciudad de Ica, Perú. Rev Med Hered, jul./set. 2012, vol.23, no.3, p.154-159. ISSN 1018-130X.

Objectives: To determine the in-vitro therapeutic equivalence of three formulations of diazepam in tablets of 10mg to establish their interchangeability with the original brand name product. Methods: Descriptive and comparative study performed in September 2010 using three generic presentations dispended in the city of Ica compared to the original brand name product Diazepam (Valium®) from Roche Pharmaceutical Laboratories. We determined the dissolution profiles performed in similar media at physiologic pH based on WHO recommendations (Technical report 937). To establish therapeutic equivalence, we used the similarity factor (f2) and considered therapeutic equivalence if values were between 50 and 100. Results: All presentations had a very rapid dissolution at pH=1.2. However, the three generic presentations and the brand name product had slower dissolutions with f2 values at pH=4.5 of 76.0 for Generic A; 68.9 for Generic B; and 30.5 for Generic C, and f2 values at pH=6.8 of 60.6 for Generic A; 78.2 for Generic B and 20.4 for Generic C, respectively. Conclusions: Based on the f2 values found for the three generic presentations of diazepam, only the generic C presentation was not equivalent compared to the brand name product.

Palabras llave: Therapeutic equivalency; WHO; diazepam.