<?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>0186-2391</journal-id>
<journal-title><![CDATA[Acta pediátrica de México]]></journal-title>
<abbrev-journal-title><![CDATA[Acta pediatr. Méx]]></abbrev-journal-title>
<issn>0186-2391</issn>
<publisher>
<publisher-name><![CDATA[Instituto Nacional de Pediatría]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0186-23912016000400191</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Farmacocinética comparada de metformina, en forma sólida y en formulación extemporánea líquida para pediatría, en voluntarios adultos sanos]]></article-title>
<article-title xml:lang="en"><![CDATA[Pharmacokinetics of metformin in split tablets and in a liquid extemporaneous formulation for paediatrics, in healthy adult volunteers]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rivera-Espinosa]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pérez-Guillé]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Chávez-Pacheco]]></surname>
<given-names><![CDATA[JL]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Torres-Espíndola]]></surname>
<given-names><![CDATA[LM]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Juárez-Olguín]]></surname>
<given-names><![CDATA[H]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alemón-Medina]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Secretaría de Salud Instituto Nacional de Pediatría Laboratorio de Farmacología]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>México</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2016</year>
</pub-date>
<volume>37</volume>
<numero>4</numero>
<fpage>191</fpage>
<lpage>203</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S0186-23912016000400191&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S0186-23912016000400191&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S0186-23912016000400191&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen:  ANTECEDENTES: fraccionar o pulverizar tabletas de metformina para ajustar dosis pediátricas dificulta su administración, genera inestabilidad del fármaco (oxidación/fotosensibilidad) y relativiza su biodisponibilidad. Se propone como alternativa de ajuste de dosis y de uniformidad de contenido una formulación extemporánea líquida a partir de tabletas de marca comercial.  OBJETIVO:  determinar la biodisponibilidad de metformina en formulación líquida, en voluntarios adultos sanos, para demostrar que su comportamiento farmacocinético permanece inalterado.  MATERIALES Y MÉTODOS: estudio clínico, aleatorio, cruzado y longitudinal, en adultos sanos voluntarios (n=12), 7 varones y 5 mujeres, de 24.3 ± 1.8 años, con índice de masa corporal = 24.9 ± 2.5 kg/m2. Se obtuvieron muestras sanguíneas en gotas, colectadas en tarjetas Whatman 903®, a las 0.25, 0.5, 1, 2, 4, 8 y 12 horas de ingerir 250 mg del fármaco. Se extrajo el fármaco a partir de 5 discos de papel filtro con sangre impregnada (16 &#956;L), por precipitación directa, con acetonitrilo (ACN) y metanol. La detección fue en una columna AcQuity UPLC BEH HILIC (2.1 × 100mm, 1.7 &#956;m) por espectrometría de masas en tándem. Fase móvil: acetato de amonio 5 mM y ACN (80:20; v/v), a 0.25 mL/ min isocráticamente. La farmacocinética se determinó mediante el programa Win Nonlin Pro 3.1 y las diferencias se evaluaron por ANOVA de una vía (p &#8804; 0.05).  RESULTADOS: el método fue exacto, preciso, selectivo y lineal entre 50 y 1000 ng/mL, coeficiente de determinación (r) de 0.9982. Las muestras extraídas y almacenadas a 4°C fueron estables por 17 horas y hasta 2 meses a -80°C. La metformina en tableta tuvo una Cmáx de 553.4 ng/mL y de 692.2 ng/mL con la formulación líquida. El Tmáx fue menor con la solución edulcorada (1.6 h) que con la tableta (1.8 h). La ke fue menor con la forma líquida (0.29 vs. 0.32 h-1), lo que sugiere que se eliminó más rápidamente. El AUC0-12 fue igual en ambas formas (F=0.002, Fcrit=6.3).  CONCLUSIONES: la formulación líquida de metformina es igualmente biodisponible que la forma farmacéutica original, con la ventaja de permitir dosis menores que la tableta, ajuste preciso de dosis y uniformidad de contenido.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract:  BACKGROUND: Homemade fractions of metformin tablets to adjust paediatric doses are difficult to administer, unstable and yields variable doses. In this work, a liquid extemporaneous formulation of metformin, sweetened with 1% sucralose, is proposed.  PURPOSE: To determine the pharmacokinetics of the new formulation compared to the fractionated tablet in healthy adult volunteers and to demonstrate that it remains unaltered.  METHODS: Randomised, crossed and longitudinal clinical trial, in 12 healthy adult volunteers, 7 males and 5 females (n=12), 24.3 ± 1.8 years, with BMI = 24.9 ± 2.5. Eight blood samples were obtained in Whatman 903® cards at 0, 0.25, 0.5, 1, 2, 4, 8 and 12 hours after administration of 250 mg metformin. Extraction was made by direct precipitation with acetonitrile (ACN) and methanol. Detection was carried out by UPLC and tandem mass spectrometry. Mobile phase: 5 mM ammonium acetate and ACN (80:20; v/v), 0.25 mL/min, isocratically. Pharmacokinetics was determined using WinNonlin Pro 3.1 software and analysed by one-way ANOVA (p &#8804; 0.05).  RESULTS: The method was accurate, precise, selective and linear from 50 to 1000 ng/mL (r=0.9982). Samples were stable at 4°C for 17 hours and for 2 months at -80°C. The metformin formulation had a Cmax of 652 ng/mL and 550 ng/mL in the tablet. Tmax and ke were lower with the formulation (1.6 h vs. 1.8 h and 0.32 h-1 vs. 0.29 h-1). The AUC0-12 was virtually the same in both forms (F%=1.01).  CONCLUSIONS: The liquid formulation of metformin showed similar pharmacokinetics to the split tablet, but it additionally allows a more precise dose adjustment, ease of administration and uniformity of content.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[metformina]]></kwd>
<kwd lng="es"><![CDATA[farmacocinética]]></kwd>
<kwd lng="es"><![CDATA[formulación farmacéutica]]></kwd>
<kwd lng="es"><![CDATA[asistentes de pediatría]]></kwd>
<kwd lng="en"><![CDATA[metformin]]></kwd>
<kwd lng="en"><![CDATA[pharmacokinetics]]></kwd>
<kwd lng="en"><![CDATA[drug formulations]]></kwd>
</kwd-group>
</article-meta>
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