Klinische Pharmakologie und Biopharmazeutik

Abstrakt

Study of in vitro Therapeutic Equivalence of the 5 mg Glibenclamide Multi-source Tablets Respecting the Reference Medicine Product

Angel Alvarado-Yarasca, Ana María Muñoz-Jauregui, Luis Quiñones-Sepúlveda, Frank Lizaraso-Soto, Alberto Salazar-Granara, Luis Sullón- Dextre, Juan José Palomino-Jhong and Jorge Antonio García-Ceccarelli

Introduction: Therapeutic equivalence of medications is carried out through in vitro and in vivo studies called bioequivalence studies.

Objective: To determine the in vitro therapeutic equivalence of the 5 mg glibenclamide multi-source tablets respecting the reference medicine.

Materials and methods: Both, the multi-source drug 5 mg glibenclamide and the reference 5 mg Glidiabet are made in Peru, and were acquired in a drugstore of Ica city (Peru). Reagents and an analytical grade standard were used. The Ultraviolet absorption method at 300 nm was used on each of the three dissolution media.

Results: Neither the multi-source drug T nor the reference R dissolved by 85% at pH 1.2 and at pH 4.5, during 15 or 30 minutes. However, at pH 6.8 dissolution occurs. These results correspond to Food and Drug Administration and United States Pharmacopoeia criteria. The similarity factor value was within the acceptance range (50-100) for the three tested pHs. Dissolution efficiency was 68.66% (pH 1.2), 56.59% (pH 4.5) and 95.98% (pH 6.8). The mean of in vitro dissolution time was 28.56 min (pH 1.2), 39.97 min (pH 4.5) and 4.54 min (pH 6.8).

Conclusion: According to the similarity factor (f2) and the efficiency of dissolution, it is concluded that the multisource drug 5 mg glibenclamide of the present study is therapeutically equivalent in vitro to the reference 5 mg Glidiabet.