<?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>2340-9894</journal-id>
<journal-title><![CDATA[Ars Pharmaceutica (Internet)]]></journal-title>
<abbrev-journal-title><![CDATA[Ars Pharm]]></abbrev-journal-title>
<issn>2340-9894</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Granada]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2340-98942025000400450</article-id>
<article-id pub-id-type="doi">10.30827/ars.v66i4.33615</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Formulation and Evaluation of Quetiapine Fumarate Extended-Release Matrix Tablets Using Metolose 15000SR and HPMC K15CR]]></article-title>
<article-title xml:lang="es"><![CDATA[Formulación y Evaluación de Comprimidos de Liberación Prolongada de Fumarato de Quetiapina Utilizando Metolose 15000SR y HPMC K15CR]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Muruganantham]]></surname>
<given-names><![CDATA[Subhalakshmi]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
<xref ref-type="aff" rid="A a"/>
<xref ref-type="aff" rid="A3"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Babu R]]></surname>
<given-names><![CDATA[Venkatesh]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sekharan Thenrajan]]></surname>
<given-names><![CDATA[Raja]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Sankaralingam Bhuvaneswari College of Pharmacy Department of Pharmaceutics Anaikuttam-626130]]></institution>
<addr-line><![CDATA[Sivakasi Tamil Nadu]]></addr-line>
<country>India</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Pharmafabrikon Research and Development Department ]]></institution>
<addr-line><![CDATA[Madurai Tamil Nadu]]></addr-line>
<country>India</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Ennam College of Pharmacy Department of Pharmaceutics ]]></institution>
<addr-line><![CDATA[Coimbatore Tamil Nadu]]></addr-line>
<country>India</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>12</month>
<year>2025</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>12</month>
<year>2025</year>
</pub-date>
<volume>66</volume>
<numero>4</numero>
<fpage>450</fpage>
<lpage>465</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2340-98942025000400450&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2340-98942025000400450&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2340-98942025000400450&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract Introduction: Quetiapine Fumarate (QF) is a second-generation antipsychotic used to treat schizophrenia and bipolar depression. Extended-release (ER) tablets help improve patient compliance and reduce side effects by slowing down drug absorption. Method: In this study, QF-ER tablets were made using the wet granulation method with two polymers, Metolose 15000 SR and Hydroxypropylmethylcellulose (HPMC) K15CR, in different amounts. To check compatibility, QF was mixed with other ingredients and stored at room temperature for 15 days. There were no significant changes in color or odor, and infrared spectral analysis confirmed that QF was compatible with the polymers and other excipients, with no interactions. The prepared granules had good to excellent flowability, ensuring even tablet compression. The finished tablets were tested for weight, hardness, thickness, friability, drug content, drug release, and release kinetics. Results: All formulations had a good appearance without defects, and all values met pharmacopeial standards. Among the five formulations, F5 showed the best performance, releasing 98.77 % of the drug over 24 hours, like the market sample (97.21 % in 24 hours). The drug release from F5 followed the Hixson-Crowell model (R² = 0.9997), indicating that the release was controlled by both tablet erosion and diffusion. The release exponent (n = 0.6123) suggested a combination of swelling and diffusion as the drug release mechanism. Conclusions: F5 was identified as the best formulation, as it met all pharmacopeial requirements, had excellent physical properties, and provided a well-controlled, extended drug release for 24 hours, making it a strong alternative to the market.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen Introducción: El fumarato de quetiapina (QF) es un antipsicótico de segunda generación utilizado para tratar la esquizofrenia y la depresión bipolar. Los comprimidos de liberación prolongada (ER) ayudan a mejorar la adherencia del paciente y a reducir los efectos secundarios al ralentizar la absorción del medicamento. Método: En este estudio, se prepararon comprimidos de liberación prolongada de QF (QF-ER) utilizando el método de granulación húmeda con dos polímeros, Metolose 15000 SR e Hidroxipropilmetilcelulosa (HPMC) K15CR, en diferentes cantidades. Para comprobar la compatibilidad, el QF se mezcló con otros ingredientes y se almacenó a temperatura ambiente durante 15 días. No se observaron cambios significativos en el color ni en el olor, y el análisis espectral infrarrojo confirmó que el QF era compatible con los polímeros y otros excipientes, sin interacciones. Los gránulos preparados mostraron una fluidez de buena a excelente, lo que garantizó una compresión uniforme de los comprimidos. Los comprimidos terminados se evaluaron en cuanto a peso, dureza, grosor, friabilidad, contenido de fármaco, liberación del fármaco y cinética de liberación. Resultados: Todas las formulaciones presentaron una buena apariencia sin defectos, y todos los valores cumplieron con los estándares farmacopeicos. Entre las cinco formulaciones, la F5 mostró el mejor desempeño, liberando el 98,77 % del fármaco en 24 horas, similar a la muestra del mercado (97,21 % en 24 horas). La liberación del fármaco de la formulación F5 siguió el modelo de Hixson-Crowell (R² = 0,9997), lo que indica que la liberación fue controlada tanto por la erosión de la tableta como por la difusión. El exponente de liberación (n = 0,6123) sugiere que el mecanismo de liberación del fármaco fue una combinación de hinchamiento y difusión. Conclusiones: La F5 fue identificada como la mejor formulación, ya que cumplió con todos los requisitos farmacopeicos, presentó excelentes propiedades físicas y ofreció una liberación prolongada y bien controlada del fármaco durante 24 horas, lo que la convierte en una fuerte alternativa al producto del mercado.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Fumarato de quetiapina]]></kwd>
<kwd lng="es"><![CDATA[Metolosa 15000SR]]></kwd>
<kwd lng="es"><![CDATA[Hidroxipropilmetilcelulosa K15CR]]></kwd>
<kwd lng="es"><![CDATA[Comprimidos matriciales de liberación prolongada]]></kwd>
<kwd lng="en"><![CDATA[Quetiapine fumarate]]></kwd>
<kwd lng="en"><![CDATA[Metolose 15000SR]]></kwd>
<kwd lng="en"><![CDATA[Hydroxypropylmethylcellulose K15CR]]></kwd>
<kwd lng="en"><![CDATA[Extended-release matrix tablets]]></kwd>
</kwd-group>
</article-meta>
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