SciELO - Scientific Electronic Library Online

vol.23 issue3Relationship between post-mictional residue, degree of bladder trabeculation and urinary flow in patients with benign prostatic hyperplasiaValidation of a questionnaire to measure knowledge and beliefs about epilepsy in parents author indexsubject indexarticles search
Home Pagealphabetic serial listing  

Services on Demand




  • Have no cited articlesCited by SciELO

Related links

  • Have no similar articlesSimilars in SciELO


Revista Medica Herediana

Print version ISSN 1018-130X


HERRERA-CALDERON, Oscar  and  GRANDE-ORTIZ, Miguel. Therapeutic equivalency of tablets of diazepam dispended in the city of Ica, Peru. Rev Med Hered [online]. 2012, vol.23, n.3, pp.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.

Keywords : Therapeutic equivalency; WHO; diazepam.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )