Evaluation of thermal stability of enalapril maleate tablets using thermogravimetry and differential scanning calorimetry
Differential scanning calorimetry (DSC) and thermogravimetry (TG) were used in order to evaluate the thermal stability of an enalapril maleate formulation packaged in two types of packaging, polyvinyl chloride/aluminum blister and aluminum strip. Enalapril and the excipients employed in the formulat...
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| Veröffentlicht in: | Journal of thermal analysis and calorimetry 2016-03, Vol.123 (3), p.1943-1949 |
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| container_end_page | 1949 |
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| container_issue | 3 |
| container_start_page | 1943 |
| container_title | Journal of thermal analysis and calorimetry |
| container_volume | 123 |
| creator | de Souza, Steffany Manzan Marques e Melo Franco, Pedro Ivo Brandão Leles, Maria Inês Gonçalves da Conceição, Edemilson Cardoso |
| description | Differential scanning calorimetry (DSC) and thermogravimetry (TG) were used in order to evaluate the thermal stability of an enalapril maleate formulation packaged in two types of packaging, polyvinyl chloride/aluminum blister and aluminum strip. Enalapril and the excipients employed in the formulation were also evaluated by TG and DSC. Tablets were analyzed before and after storage in an acclimatized room at 40 °C and relative humidity of 75 % for 90 days. The DSC and TG results were compared with the results of dosage of enalapril and related compounds obtained by high-performance liquid chromatography. These results indicate an occurrence of chemical interaction between enalapril maleate and the excipients during its storage. After storage, it was observed that the enalapril content reduced and the predominant degradation product was diketopiperazine for both types of packaging. The predominance of diketopiperazine could be related to the absence of sodium bicarbonate in the tablets, alkalinizing agent employed in the thermal stabilization of the drug. |
| doi_str_mv | 10.1007/s10973-015-4648-3 |
| format | Article |
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Enalapril and the excipients employed in the formulation were also evaluated by TG and DSC. Tablets were analyzed before and after storage in an acclimatized room at 40 °C and relative humidity of 75 % for 90 days. The DSC and TG results were compared with the results of dosage of enalapril and related compounds obtained by high-performance liquid chromatography. These results indicate an occurrence of chemical interaction between enalapril maleate and the excipients during its storage. After storage, it was observed that the enalapril content reduced and the predominant degradation product was diketopiperazine for both types of packaging. The predominance of diketopiperazine could be related to the absence of sodium bicarbonate in the tablets, alkalinizing agent employed in the thermal stabilization of the drug.</description><identifier>ISSN: 1388-6150</identifier><identifier>EISSN: 1588-2926</identifier><identifier>EISSN: 1572-8943</identifier><identifier>DOI: 10.1007/s10973-015-4648-3</identifier><language>eng</language><publisher>Dordrecht: Springer Netherlands</publisher><subject>Aluminum ; Analysis ; Analytical Chemistry ; Calorimetry ; Chemistry ; Chemistry and Materials Science ; Differential scanning calorimetry ; Enalapril ; Excipients ; High performance liquid chromatography ; Inorganic Chemistry ; Maleates ; Measurement Science and Instrumentation ; Packaging ; Physical Chemistry ; Polymer Sciences ; Tablets ; Thermal stability ; Thermogravimetry</subject><ispartof>Journal of thermal analysis and calorimetry, 2016-03, Vol.123 (3), p.1943-1949</ispartof><rights>Akadémiai Kiadó, Budapest, Hungary 2015</rights><rights>COPYRIGHT 2016 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c529t-ed5fd1692e68a4e46d2aee2c913c7813ff2de160459caf2ade1525de982d2ea43</citedby><cites>FETCH-LOGICAL-c529t-ed5fd1692e68a4e46d2aee2c913c7813ff2de160459caf2ade1525de982d2ea43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10973-015-4648-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10973-015-4648-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids></links><search><creatorcontrib>de Souza, Steffany Manzan Marques</creatorcontrib><creatorcontrib>e Melo Franco, Pedro Ivo Brandão</creatorcontrib><creatorcontrib>Leles, Maria Inês Gonçalves</creatorcontrib><creatorcontrib>da Conceição, Edemilson Cardoso</creatorcontrib><title>Evaluation of thermal stability of enalapril maleate tablets using thermogravimetry and differential scanning calorimetry</title><title>Journal of thermal analysis and calorimetry</title><addtitle>J Therm Anal Calorim</addtitle><description>Differential scanning calorimetry (DSC) and thermogravimetry (TG) were used in order to evaluate the thermal stability of an enalapril maleate formulation packaged in two types of packaging, polyvinyl chloride/aluminum blister and aluminum strip. Enalapril and the excipients employed in the formulation were also evaluated by TG and DSC. Tablets were analyzed before and after storage in an acclimatized room at 40 °C and relative humidity of 75 % for 90 days. The DSC and TG results were compared with the results of dosage of enalapril and related compounds obtained by high-performance liquid chromatography. These results indicate an occurrence of chemical interaction between enalapril maleate and the excipients during its storage. After storage, it was observed that the enalapril content reduced and the predominant degradation product was diketopiperazine for both types of packaging. The predominance of diketopiperazine could be related to the absence of sodium bicarbonate in the tablets, alkalinizing agent employed in the thermal stabilization of the drug.</description><subject>Aluminum</subject><subject>Analysis</subject><subject>Analytical Chemistry</subject><subject>Calorimetry</subject><subject>Chemistry</subject><subject>Chemistry and Materials Science</subject><subject>Differential scanning calorimetry</subject><subject>Enalapril</subject><subject>Excipients</subject><subject>High performance liquid chromatography</subject><subject>Inorganic Chemistry</subject><subject>Maleates</subject><subject>Measurement Science and Instrumentation</subject><subject>Packaging</subject><subject>Physical Chemistry</subject><subject>Polymer Sciences</subject><subject>Tablets</subject><subject>Thermal stability</subject><subject>Thermogravimetry</subject><issn>1388-6150</issn><issn>1588-2926</issn><issn>1572-8943</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><recordid>eNp9kU1rHSEUhofSQtO0P6C7gW7axSTqOF5dhpC2gUCgH2s51ePU4GiqTuj993WYbi6U4kI953kO6Nt1bym5oIQcLgsl6jAOhE4DF1wO47PujE5SDkwx8bydx3YWdCIvu1elPBBClCL0rDvePEFYofoU--T6-hPzAqEvFX744OtxK2KEAI_Zh761ECr2rRuwln4tPs67lOYMT37Bmo89RNtb7xxmjNVv4wzEuKEGQso79bp74SAUfPN3P---f7z5dv15uLv_dHt9dTeYiak6oJ2cpUIxFBI4cmEZIDKj6GgOko7OMYtUED4pA45Bu0xssqgkswyBj-fd-33uY06_VixVL74YDAEiprVoKokkh1GyDX23o3N7p_bRpZrBbLi-4pwzToQgjbr4B9WWxcWbFNH5Vj8RPpwIjan4u86wlqJvv345ZenOmpxKyeh0-_gF8lFTorek9Z60bknrLWk9NoftTmlsnDHrh7TmFlr5j_QHElitCQ</recordid><startdate>20160301</startdate><enddate>20160301</enddate><creator>de Souza, Steffany Manzan Marques</creator><creator>e Melo Franco, Pedro Ivo Brandão</creator><creator>Leles, Maria Inês Gonçalves</creator><creator>da Conceição, Edemilson Cardoso</creator><general>Springer Netherlands</general><general>Springer</general><scope>AAYXX</scope><scope>CITATION</scope><scope>ISR</scope><scope>7SR</scope><scope>7U5</scope><scope>8BQ</scope><scope>8FD</scope><scope>JG9</scope><scope>L7M</scope></search><sort><creationdate>20160301</creationdate><title>Evaluation of thermal stability of enalapril maleate tablets using thermogravimetry and differential scanning calorimetry</title><author>de Souza, Steffany Manzan Marques ; e Melo Franco, Pedro Ivo Brandão ; Leles, Maria Inês Gonçalves ; da Conceição, Edemilson Cardoso</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c529t-ed5fd1692e68a4e46d2aee2c913c7813ff2de160459caf2ade1525de982d2ea43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aluminum</topic><topic>Analysis</topic><topic>Analytical Chemistry</topic><topic>Calorimetry</topic><topic>Chemistry</topic><topic>Chemistry and Materials Science</topic><topic>Differential scanning calorimetry</topic><topic>Enalapril</topic><topic>Excipients</topic><topic>High performance liquid chromatography</topic><topic>Inorganic Chemistry</topic><topic>Maleates</topic><topic>Measurement Science and Instrumentation</topic><topic>Packaging</topic><topic>Physical Chemistry</topic><topic>Polymer Sciences</topic><topic>Tablets</topic><topic>Thermal stability</topic><topic>Thermogravimetry</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>de Souza, Steffany Manzan Marques</creatorcontrib><creatorcontrib>e Melo Franco, Pedro Ivo Brandão</creatorcontrib><creatorcontrib>Leles, Maria Inês Gonçalves</creatorcontrib><creatorcontrib>da Conceição, Edemilson Cardoso</creatorcontrib><collection>CrossRef</collection><collection>Gale In Context: Science</collection><collection>Engineered Materials Abstracts</collection><collection>Solid State and Superconductivity Abstracts</collection><collection>METADEX</collection><collection>Technology Research Database</collection><collection>Materials Research Database</collection><collection>Advanced Technologies Database with Aerospace</collection><jtitle>Journal of thermal analysis and calorimetry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>de Souza, Steffany Manzan Marques</au><au>e Melo Franco, Pedro Ivo Brandão</au><au>Leles, Maria Inês Gonçalves</au><au>da Conceição, Edemilson Cardoso</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of thermal stability of enalapril maleate tablets using thermogravimetry and differential scanning calorimetry</atitle><jtitle>Journal of thermal analysis and calorimetry</jtitle><stitle>J Therm Anal Calorim</stitle><date>2016-03-01</date><risdate>2016</risdate><volume>123</volume><issue>3</issue><spage>1943</spage><epage>1949</epage><pages>1943-1949</pages><issn>1388-6150</issn><eissn>1588-2926</eissn><eissn>1572-8943</eissn><abstract>Differential scanning calorimetry (DSC) and thermogravimetry (TG) were used in order to evaluate the thermal stability of an enalapril maleate formulation packaged in two types of packaging, polyvinyl chloride/aluminum blister and aluminum strip. Enalapril and the excipients employed in the formulation were also evaluated by TG and DSC. Tablets were analyzed before and after storage in an acclimatized room at 40 °C and relative humidity of 75 % for 90 days. The DSC and TG results were compared with the results of dosage of enalapril and related compounds obtained by high-performance liquid chromatography. These results indicate an occurrence of chemical interaction between enalapril maleate and the excipients during its storage. After storage, it was observed that the enalapril content reduced and the predominant degradation product was diketopiperazine for both types of packaging. The predominance of diketopiperazine could be related to the absence of sodium bicarbonate in the tablets, alkalinizing agent employed in the thermal stabilization of the drug.</abstract><cop>Dordrecht</cop><pub>Springer Netherlands</pub><doi>10.1007/s10973-015-4648-3</doi><tpages>7</tpages></addata></record> |
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| ispartof | Journal of thermal analysis and calorimetry, 2016-03, Vol.123 (3), p.1943-1949 |
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| language | eng |
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| source | SpringerLink Journals - AutoHoldings |
| subjects | Aluminum Analysis Analytical Chemistry Calorimetry Chemistry Chemistry and Materials Science Differential scanning calorimetry Enalapril Excipients High performance liquid chromatography Inorganic Chemistry Maleates Measurement Science and Instrumentation Packaging Physical Chemistry Polymer Sciences Tablets Thermal stability Thermogravimetry |
| title | Evaluation of thermal stability of enalapril maleate tablets using thermogravimetry and differential scanning calorimetry |
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