Evaluation of the alprazolam tablets 0.5 mg: a comparative study over references medicines, generic and similars medicines

Abstract

About 20 % of the Brazilian population is affected by anxiety disorders are more prevalent among women aged between 34 and 59 years and alprazolam is the second most widely used anxiolytic to treat this pathology. As to the characteristics of tablets, these must have physical and chemical stabilities, disintegrate at the expected time, be little crumbly, also smooth and shiny surface.The aim of this work was to evaluate the quality of alprazolam 0.5 mg tablets, making the comparison between reference, generic and similar medicines commercially available, as regards the visual aspect and the average weight tests, hardness and friability. For the assay, 270 uncoated tablets of 0.5 mg alprazolam were used, from three different laboratories. Among them, 90 were from Reference category medicines (Group A), 90 were Generic medicines (group B) and 90, Similar medicines (group C). Each group was composed of three subgroups corresponding to different batches, and each subgroup contained 30 tablets of the same lot. The assay was done in triplicate. Thus, the group A was composed of lots A1, A2, and A3; Group B consisted of the lots B1, B2 and
B3 and the group C consisted of lots C1, C2, and C3. All lots were approved in the assays average weight and friability. However, considering package, the group C presented the number of the lot and expiration date illegible; and in the hardness test, two tablets of C1 lot showed hardness below of the specifications described by the Brazilian Pharmacopeia 5th Edition.