<?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>0121-4004</journal-id>
<journal-title><![CDATA[Vitae]]></journal-title>
<abbrev-journal-title><![CDATA[Vitae]]></abbrev-journal-title>
<issn>0121-4004</issn>
<publisher>
<publisher-name><![CDATA[Facultad de Química Farmacéutica, Universidad de Antioquia]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0121-40042022000100001</article-id>
<article-id pub-id-type="doi">10.17533/udea.vitae.v29n1a347467</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Quality Control Study of Different Products from Famotidine Tablets in the Iraqi Market]]></article-title>
<article-title xml:lang="es"><![CDATA[Estudio de Control de Calidad de Diferentes Productos de Tabletas de Famotidina en el Mercado Iraquí]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Awish Jassem]]></surname>
<given-names><![CDATA[Nizar]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Al-Ayen University College of Pharmacy ]]></institution>
<addr-line><![CDATA[Thi-Qar ]]></addr-line>
<country>Iraq</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2022</year>
</pub-date>
<volume>29</volume>
<numero>1</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0121-40042022000100001&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0121-40042022000100001&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0121-40042022000100001&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Background:  In developing countries, particularly in Iraq, the use of generic medicines has been increasing in recent years, primarily as a cost-saving measure in healthcare provision. In the Iraqi market, famotidine tablets are available from different pharmaceutical companies. As a result, regular pre-marketing quality testing is required to check the quality and identify which product might safely substitute the innovator product in the event of the innovator brand&#8217;s unavailability or high cost.  Objective:  various quality control tests have been conducted to determine the Pharmaceutical Equivalence of the different generic and brands of Famotidine film-coated tablets marketed in Iraq.  Materials and Methods:  Four different samples of the most commonly available Famotidine 20 mg tablets in the Iraqi market were tested for drug contents, friability, and hardness. Additionally, the in-vitro drug release and kinetics were evaluated.  Results:  slight differences in the products&#8217; content were found; however, they were within the acceptable requirement of British Pharmacopeia (BP) and The United States Pharmacopoeia (USP) 30, NF 25. Similarly, the friability and hardness were within the excellent range according to the B.P. and USP. The results of our study indicated that the tested brand (Famodin) and the three generic products (Famosam, Ulceran, and Famodar) of Famotidine tablets have a unique pattern of in-vitro release profiles. However, all the tested brands and generic pills complied with the USP specifications for the immediate release dosage forms except for Famosam. Release kinetic for the four tested products indicates first-order kinetic models.  Conclusion:  The findings revealed that nearly all of the tested Famotidine tablet brands and generics met the pharmacopeial requirements for oral tablets. As a result, if acquiring the innovative brand of famotidine tablets is difficult to obtain, healthcare providers may be advised to use the tested products instead.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Antecedentes:  En los países en vías de desarrollo, especialmente en Irak, el uso de medicamentos genéricos ha aumentado en los últimos años, principalmente como medida de ahorro en la prestación de servicios sanitarios. En el mercado iraquí, los comprimidos de famotidina están disponibles en diferentes empresas farmacéuticas. Por ello, es necesario realizar periódicamente pruebas de calidad previas a la comercialización para comprobar la calidad e identificar qué producto podría sustituir con seguridad al producto innovador en caso de que éste no esté disponible o tenga un coste elevado.  Objetivo:  se han realizado varias pruebas de control de calidad para determinar la Equivalencia Farmacéutica de los diferentes genéricos y marcas de Famotidina comprimidos recubiertos con película comercializados en Irak.  Materiales y métodos:  Se analizaron cuatro muestras diferentes de los comprimidos de 20 mg de Famotidina más comunes en el mercado iraquí para determinar el contenido de fármaco, la friabilidad y la dureza. Además, se evaluó la liberación in-vitro del fármaco y su cinética.  Resultados:  Se encontraron ligeras diferencias en el contenido de los productos; sin embargo, estaban dentro de los requisitos aceptables de B.P. y de la Farmacopea de Estados Unidos (USP) 30, NF 25. Así mismo, la friabilidad y la dureza estaban dentro del rango excelente según la B.P. y la USP. Los resultados de nuestro estudio indicaron que la marca probada (Famodin) y los tres productos genéricos (Famosam, Ulceran y Famodar) de comprimidos de famotidina tienen un patrón único de perfiles de liberación in-vitro. Sin embargo, todas las marcas y los comprimidos genéricos probados cumplieron con las especificaciones de la USP para las formas farmacéuticas de liberación inmediata, excepto Famosam. La cinética de liberación de los cuatro productos probados indica modelos cinéticos de primer orden.  Conclusiones:  Los resultados revelaron que casi todas las marcas y genéricos de comprimidos de Famotidina probados cumplían los requisitos farmacopeicos para los comprimidos orales. En consecuencia, si resulta difícil adquirir la marca innovadora de comprimidos de famotidina, se puede aconsejar a los profesionales sanitarios que utilicen los productos probados en su lugar.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Generic Drug Famosam Famodin Release kinetics]]></kwd>
<kwd lng="es"><![CDATA[Genérico medicamento Famosam Famodin cinéticas de liberación]]></kwd>
</kwd-group>
</article-meta>
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<surname><![CDATA[AL- Edresi]]></surname>
<given-names><![CDATA[SS]]></given-names>
</name>
<name>
<surname><![CDATA[AL- Gburi]]></surname>
<given-names><![CDATA[KM]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[A Comparative study of quality control testing on candesartan cilexetil conventional tablets in Iraq]]></article-title>
<source><![CDATA[Int J App Pharm]]></source>
<year>2020</year>
<volume>12</volume>
<numero>2</numero>
<issue>2</issue>
<page-range>103-8</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
