<?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>S2340-98942018000100002</article-id>
<article-id pub-id-type="doi">10.30827/ars.v59i1.7274</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Development and characterization of a novel nano-liposomal formulation of Alendronate Sodium loaded with biodegradable polymer]]></article-title>
<article-title xml:lang="es"><![CDATA[Desarrollo y caracterización de una nueva formulación nano-liposómica de alendronato sódico con un polímero biodegradable]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Salem]]></surname>
<given-names><![CDATA[Heba F.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Kharshoum]]></surname>
<given-names><![CDATA[Rasha M.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Mahmoud]]></surname>
<given-names><![CDATA[Mohamed]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Azim]]></surname>
<given-names><![CDATA[Saleh A.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ebeid]]></surname>
<given-names><![CDATA[EL-Zeiny M.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Beni-Suef University Faculty of Pharmacy Department of Pharmaceutics and Industrial Pharmacy]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Egypt</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Tanta University Faculty of Science Chemistry Department]]></institution>
<addr-line><![CDATA[Tanta ]]></addr-line>
<country>Egypt</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>03</month>
<year>2018</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>03</month>
<year>2018</year>
</pub-date>
<volume>59</volume>
<numero>1</numero>
<fpage>9</fpage>
<lpage>20</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S2340-98942018000100002&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S2340-98942018000100002&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S2340-98942018000100002&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Background: Alendronate Sodium (ALDS) is the drug of choice for treatment of osteoporosis. However, 50% of the osteoporotic patients ceased the treatment within the first year due to its potential side effect on the gastrointestinal tract (GIT).  Objective: The current study aimed to utilize nanotechnology to develop a nano-oral liposomal preparation containing biodegradable polymer (Starch) that enhance the drug prosperities.  Methods: Nanoliposomes of ALDS were prepared using different concentrations of solubilized starch (0.1 - 0.5 g) by thin film hydration method. A new method of alendronate quantitative determination was used to overcome the obstacle of its determination by using a new highly sensitive derivatization method. The selected formula was visualized using TEM, in vitro release studies and Stability study was also carried out. Furthermore, ulcerogenicity studies were performed to compare between the optimum prepared formula and a standard nonliposomal ALDS.  Results: Six nano-oral liposomal formulations were prepared with zeta potentials ranging from -12 mV to -39 mV and a particle size ranging from 94 nm to 298 nm. The encapsulation efficiency studies demonstrated that the amount of ALDS entrapped within liposomes increased with increasing starch concentration. The stability studies confirmed the role of starch in increasing the stability of the prepared liposomes. In vitro release studies have demonstrated a relative delay in ALDS releases from the liposome core. Ulcerogenicity studies proofed that the prepared formula has a significant gastric tolerance.  Conclusion: a novel liposomal formula of ALDS was developed with better tolerability. However, further clinical investigations are necessary to evaluate its therapeutic effectiveness.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Antecedentes: El alendronato sódico (ALDS) es el fármaco de elección para el tratamiento de la osteoporosis. Sin embargo, el 50% de los pacientes osteoporóticos cesaron el tratamiento en el primer año debido a su posible efecto secundario en el tracto gastrointestinal (GIT).  Objetivo: El presente estudio tiene como objetivo utilizar la nanotecnología para desarrollar una preparación liposomal nano-oral que contiene polímero biodegradable (almidón) que mejoran la prosperidad de la droga. Métodos: Se prepararon nanoliposomas de ALDS utilizando diferentes concentraciones de almidón solubilizado (0,1 - 0,5 g) mediante un método de hidratación de película delgada. Se utilizó un nuevo método de determinación cuantitativa de alendronato para superar el obstáculo de su determinación utilizando un nuevo método de derivatización altamente sensible. La fórmula seleccionada se visualizó utilizando TEM, estudios de liberación in vitro y se realizó también un estudio de estabilidad. Además, los estudios de ulcerogenicidad se realizaron para comparar entre la fórmula óptima preparada y un estándar no liposomal ALDS.  Resultados : Se prepararon seis formulaciones liposomales nano-orales con potenciales zeta que oscilaban entre -12 mV y -39 mV y un tamaño de partícula que variaba de 94 nm a 298 nm. Los estudios de eficacia de la encapsulación demostraron que la cantidad de ALDS atrapada dentro de los liposomas aumentaba con el aumento de la concentración de almidón. Los estudios de estabilidad confirmaron el papel del almidón en el aumento de la estabilidad de los liposomas preparados. Los estudios de liberación in vitro han demostrado un retraso relativo en las liberaciones de ALDS del núcleo de liposomas. Los estudios de ulcerogenicidad demostraron que la fórmula preparada tiene una tolerancia gástrica significativa.  Conclusión: se desarrolló una nueva fórmula liposomal de ALDS con mejor tolerabilidad. Sin embargo, otras investigaciones clínicas son necesarias para evaluar su efectividad terapéutica.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Liposome]]></kwd>
<kwd lng="en"><![CDATA[Alendronate Sodium]]></kwd>
<kwd lng="en"><![CDATA[starch]]></kwd>
<kwd lng="en"><![CDATA[Ulcerogenicity studies]]></kwd>
<kwd lng="es"><![CDATA[Liposoma]]></kwd>
<kwd lng="es"><![CDATA[Alendronato Sodio]]></kwd>
<kwd lng="es"><![CDATA[almidón]]></kwd>
<kwd lng="es"><![CDATA[Estudios de ulcerogenicidad]]></kwd>
</kwd-group>
</article-meta>
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