<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>1699-714X</journal-id>
<journal-title><![CDATA[Revista de la OFIL ]]></journal-title>
<abbrev-journal-title><![CDATA[Rev. OFIL·ILAPHAR]]></abbrev-journal-title>
<issn>1699-714X</issn>
<publisher>
<publisher-name><![CDATA[Organización de Farmacéuticos Ibero-Latinoamericanos]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1699-714X2020000400007</article-id>
<article-id pub-id-type="doi">10.4321/s1699-714x2020000400009</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Aplicación del Sistema de Clasificación Biofarmacéutica al Cuadro Básico de Medicamentos de Cuba: ¿bioequivalencia in vivo o disolución in vitro?]]></article-title>
<article-title xml:lang="en"><![CDATA[Application of the Biopharmaceutical Classification System to the Basic Table of Medicines of Cuba: bioequivalence in vivo or dissolution in vitro?]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Miranda-Pérez de Alejo]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández-Cervera]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Reyes-Naranjo]]></surname>
<given-names><![CDATA[MI]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cabrera-Pérez]]></surname>
<given-names><![CDATA[MA]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Universidad Central "Marta Abreu" Centro de Bioactivos Químicos ]]></institution>
<addr-line><![CDATA[Las Villas ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad de La Habana Instituto de Farmacia y Alimentos ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Biocubafarma Unidad empresarial de base MEDSOL Laboratorios SOLMED]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2020</year>
</pub-date>
<volume>30</volume>
<numero>4</numero>
<fpage>291</fpage>
<lpage>300</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S1699-714X2020000400007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S1699-714X2020000400007&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S1699-714X2020000400007&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN El siguiente trabajo tiene como objetivos clasificar los ingredientes farmacéuticos activos (IFAs) de los sólidos orales de liberación inmediata del Cuadro Básico de Medicamentos de Cuba (CBM) que son producidos nacionalmente, según el Sistema de Clasificación Biofarmacéutica (SCB), y proponer aquellos que podrían demostrar su intercambiabilidad terapéutica a través de ensayos de disolución in vitro. Para ello se utilizó el listado de medicamentos del CBM de Cuba del 2019 y se realiza una clasificación biofarmacéutica provisional consenso, a partir de diferentes clasificaciones biofarmacéuticas publicadas y de una extensiva revisión de la literatura. Se identificó que aproximadamente el 48% de los IFAs del CBM presentan polimorfismo y que el 12,3% de las formas sólidas orales del CBM de Cuba tienen un estrecho margen terapéutico, por lo que no pueden ser bioexonerados mediante estudios de bioequivalencia in vitro basados en el SCB. Se constató que un 50,8% de los IFAs de formas sólidas orales de liberación inmediata del CBM de Cuba han sido clasificados según el SCB por la OMS. La aplicación conjunta de diversas metodologías de clasificación biofarmacéutica permitió clasificar provisionalmente todos los IFAs de las formas sólidas orales del CBM, demostrando que el 66,1% pertenece a las clases I, III y I/III del SCB, por lo que podrían ser bioexonerados de ensayos de bioequivalencia in vivo en humanos.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[SUMMARY 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.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Bioequivalencia]]></kwd>
<kwd lng="es"><![CDATA[productos genéricos]]></kwd>
<kwd lng="es"><![CDATA[equivalencia terapéutica]]></kwd>
<kwd lng="es"><![CDATA[disolución]]></kwd>
<kwd lng="es"><![CDATA[permeabilidad]]></kwd>
<kwd lng="es"><![CDATA[solubilidad]]></kwd>
<kwd lng="es"><![CDATA[Cuba]]></kwd>
<kwd lng="en"><![CDATA[Bioequivalence]]></kwd>
<kwd lng="en"><![CDATA[generic products]]></kwd>
<kwd lng="en"><![CDATA[therapeutic equivalence]]></kwd>
<kwd lng="en"><![CDATA[dissolution]]></kwd>
<kwd lng="en"><![CDATA[permeability]]></kwd>
<kwd lng="en"><![CDATA[solubility]]></kwd>
<kwd lng="en"><![CDATA[Cuba]]></kwd>
</kwd-group>
</article-meta>
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