国际标准期刊号: 2167-065X

临床药理学与生物药剂学

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索引于
  • CAS 来源索引 (CASSI)
  • 哥白尼索引
  • 谷歌学术
  • 夏尔巴·罗密欧
  • Genamics 期刊搜索
  • 参考搜索
  • 哈姆达大学
  • 亚利桑那州EBSCO
  • OCLC-世界猫
  • 普布隆斯
  • 欧洲酒吧
  • ICMJE
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抽象的

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.