Abstract

MIRANDA-PEREZ DE ALEJO, C; FERNANDEZ-CERVERA, M; REYES-NARANJO, MI  and  CABRERA-PEREZ, MA. Application of the Biopharmaceutical Classification System to the Basic Table of Medicines of Cuba: bioequivalence in vivo or dissolution in vitro?. Rev. OFIL·ILAPHAR [online]. 2020, vol.30, n.4, pp.291-300.  Epub May 25, 2021. ISSN 1699-714X.  https://dx.doi.org/10.4321/s1699-714x2020000400009.

The goals of the present work are to classify the active pharmaceutical ingredients (APIs) of the oral solids of immediate release of the Essential List of Medicines of Cuba (CBM) that are produced nationally, according to the Biopharmaceutical Classification System (BCS), and to propose those that could demonstrate their therapeutic interchangeability through in vitro dissolution tests. For this was used the Cuban CBM drug list of 2019, and a provisional consensus biopharmaceutical classification is proposed, based on different published biopharmaceutical classifications and an extensive review of the literature.

It was identified that approximately 48% of the CBM IFAs present polymorphism and that 12.3% of the oral solid forms of CBM in Cuba have a narrow therapeutic margin, for which reason they cannot be bioexonerated through in vitro bioequivalence studies based on BCS. It was found that 50.8% of the oral solid forms of CBM in Cuba have been classified according to SCB by WHO.

The joint application of diverse methodologies of biopharmaceutical classification allowed to provisionally classify all the IFAs of the oral solid forms of CBM, demonstrating that 66.1% belongs to classes I, III and I/III of the SCB, reason why they could be biowaivered from in vivo bioequivalence assays in humans.

Keywords : Bioequivalence; generic products; therapeutic equivalence; dissolution; permeability; solubility; Cuba.

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