Physical characterization of pantoprazole sodium hydrates
Only two crystal forms of pantoprazole sodium, i.e. mono and sesquihydrate, were described in the literature. The objective of the present work was to study the polymorphisms and pseudopolymorphism of pantoprazole sodium and to characterize already known and new crystal forms. Two additional hydrate...
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| Veröffentlicht in: | International journal of pharmaceutics 2005-03, Vol.291 (1), p.59-68 |
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| creator | ZUPANCIC, V OGRAJSEK, N KOTAR-JORDAN, B VRECER, F |
| description | Only two crystal forms of pantoprazole sodium, i.e. mono and sesquihydrate, were described in the literature. The objective of the present work was to study the polymorphisms and pseudopolymorphism of pantoprazole sodium and to characterize already known and new crystal forms.
Two additional hydrate forms; i.e. form A, form B and amorphous form were obtained and further characterized by means of thermal analyses, X-ray powder diffraction (XRPD), mid-infrared spectroscopy (IR), near infrared spectroscopy (NIR), Raman spectroscopy, dynamic vapour sorption (DVS), true density, contact angle and solubility. From the results it can be concluded, that the most physically stable form of pantoprazole sodium is form B, whereas form A is the least stable form. Monohydrate and form A are not physically stable and convert into form B from saturated solution/suspension or at high relative humidity. Amorphous form can be obtained by conventional spray drying method or by distillation of solvent under reduced pressure. |
| doi_str_mv | 10.1016/j.ijpharm.2004.07.043 |
| format | Article |
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Two additional hydrate forms; i.e. form A, form B and amorphous form were obtained and further characterized by means of thermal analyses, X-ray powder diffraction (XRPD), mid-infrared spectroscopy (IR), near infrared spectroscopy (NIR), Raman spectroscopy, dynamic vapour sorption (DVS), true density, contact angle and solubility. From the results it can be concluded, that the most physically stable form of pantoprazole sodium is form B, whereas form A is the least stable form. Monohydrate and form A are not physically stable and convert into form B from saturated solution/suspension or at high relative humidity. Amorphous form can be obtained by conventional spray drying method or by distillation of solvent under reduced pressure.</description><identifier>ISSN: 0378-5173</identifier><identifier>EISSN: 1873-3476</identifier><identifier>DOI: 10.1016/j.ijpharm.2004.07.043</identifier><identifier>PMID: 15707732</identifier><identifier>CODEN: IJPHDE</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>2-Pyridinylmethylsulfinylbenzimidazoles ; Benzimidazoles - analysis ; Benzimidazoles - chemistry ; Biological and medical sciences ; Chemistry, Pharmaceutical - methods ; Chemistry, Pharmaceutical - trends ; Crystallization - methods ; Drug Stability ; Dynamic vapour sorption ; General pharmacology ; Infrared spectroscopy ; Medical sciences ; Omeprazole - analogs & derivatives ; Omeprazole - analysis ; Omeprazole - chemistry ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Physical characterization ; Pseudopolymorphism ; Solubility ; Sulfoxides - analysis ; Sulfoxides - chemistry ; Technology, Pharmaceutical - methods ; Thermal analysis ; X-ray powder diffraction</subject><ispartof>International journal of pharmaceutics, 2005-03, Vol.291 (1), p.59-68</ispartof><rights>2004 Elsevier B.V.</rights><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-43523bc9da4fb69040602ff3171aeda31e646cef183d27aac6e12b11f4521ed63</citedby><cites>FETCH-LOGICAL-c393t-43523bc9da4fb69040602ff3171aeda31e646cef183d27aac6e12b11f4521ed63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0378517304006544$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>309,310,314,776,780,785,786,3536,23910,23911,25119,27903,27904,65309</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16569198$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15707732$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>ZUPANCIC, V</creatorcontrib><creatorcontrib>OGRAJSEK, N</creatorcontrib><creatorcontrib>KOTAR-JORDAN, B</creatorcontrib><creatorcontrib>VRECER, F</creatorcontrib><title>Physical characterization of pantoprazole sodium hydrates</title><title>International journal of pharmaceutics</title><addtitle>Int J Pharm</addtitle><description>Only two crystal forms of pantoprazole sodium, i.e. mono and sesquihydrate, were described in the literature. The objective of the present work was to study the polymorphisms and pseudopolymorphism of pantoprazole sodium and to characterize already known and new crystal forms.
Two additional hydrate forms; i.e. form A, form B and amorphous form were obtained and further characterized by means of thermal analyses, X-ray powder diffraction (XRPD), mid-infrared spectroscopy (IR), near infrared spectroscopy (NIR), Raman spectroscopy, dynamic vapour sorption (DVS), true density, contact angle and solubility. From the results it can be concluded, that the most physically stable form of pantoprazole sodium is form B, whereas form A is the least stable form. Monohydrate and form A are not physically stable and convert into form B from saturated solution/suspension or at high relative humidity. Amorphous form can be obtained by conventional spray drying method or by distillation of solvent under reduced pressure.</description><subject>2-Pyridinylmethylsulfinylbenzimidazoles</subject><subject>Benzimidazoles - analysis</subject><subject>Benzimidazoles - chemistry</subject><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Chemistry, Pharmaceutical - trends</subject><subject>Crystallization - methods</subject><subject>Drug Stability</subject><subject>Dynamic vapour sorption</subject><subject>General pharmacology</subject><subject>Infrared spectroscopy</subject><subject>Medical sciences</subject><subject>Omeprazole - analogs & derivatives</subject><subject>Omeprazole - analysis</subject><subject>Omeprazole - chemistry</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Physical characterization</subject><subject>Pseudopolymorphism</subject><subject>Solubility</subject><subject>Sulfoxides - analysis</subject><subject>Sulfoxides - chemistry</subject><subject>Technology, Pharmaceutical - methods</subject><subject>Thermal analysis</subject><subject>X-ray powder diffraction</subject><issn>0378-5173</issn><issn>1873-3476</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkEFr3DAQhUVpaLZpf0KLL-3NrkaSpfWplJA2gUBzSM5iVhqxWmzLlbyFza-vwxpy7Gku33tv-Bj7BLwBDvrboYmHaY95aATnquGm4Uq-YRvYGllLZfRbtuHSbOsWjLxk70s5cM61APmOXUJruDFSbFj3sD-V6LCv3FKGbqYcn3GOaaxSqCYc5zRlfE49VSX5eByq_clnnKl8YBcB-0If13vFnn7ePF7f1ve_f91d_7ivnezkXCvZCrlznUcVdrrjimsuQpBgAMmjBNJKOwqwlV4YRKcJxA4gqFYAeS2v2Ndz75TTnyOV2Q6xOOp7HCkdi9VGCdBCLmB7Bl1OpWQKdspxwHyywO2LM3uwqzP74sxyYxdnS-7zOnDcDeRfU6ukBfiyAlgWUyHj6GJ55XSrO-i2C_f9zNGi42-kbIuLNDryMZObrU_xP6_8A6GrjUQ</recordid><startdate>20050303</startdate><enddate>20050303</enddate><creator>ZUPANCIC, V</creator><creator>OGRAJSEK, N</creator><creator>KOTAR-JORDAN, B</creator><creator>VRECER, F</creator><general>Elsevier B.V</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20050303</creationdate><title>Physical characterization of pantoprazole sodium hydrates</title><author>ZUPANCIC, V ; OGRAJSEK, N ; KOTAR-JORDAN, B ; VRECER, F</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-43523bc9da4fb69040602ff3171aeda31e646cef183d27aac6e12b11f4521ed63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>2-Pyridinylmethylsulfinylbenzimidazoles</topic><topic>Benzimidazoles - analysis</topic><topic>Benzimidazoles - chemistry</topic><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Chemistry, Pharmaceutical - trends</topic><topic>Crystallization - methods</topic><topic>Drug Stability</topic><topic>Dynamic vapour sorption</topic><topic>General pharmacology</topic><topic>Infrared spectroscopy</topic><topic>Medical sciences</topic><topic>Omeprazole - analogs & derivatives</topic><topic>Omeprazole - analysis</topic><topic>Omeprazole - chemistry</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Physical characterization</topic><topic>Pseudopolymorphism</topic><topic>Solubility</topic><topic>Sulfoxides - analysis</topic><topic>Sulfoxides - chemistry</topic><topic>Technology, Pharmaceutical - methods</topic><topic>Thermal analysis</topic><topic>X-ray powder diffraction</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>ZUPANCIC, V</creatorcontrib><creatorcontrib>OGRAJSEK, N</creatorcontrib><creatorcontrib>KOTAR-JORDAN, B</creatorcontrib><creatorcontrib>VRECER, F</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of pharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>ZUPANCIC, V</au><au>OGRAJSEK, N</au><au>KOTAR-JORDAN, B</au><au>VRECER, F</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Physical characterization of pantoprazole sodium hydrates</atitle><jtitle>International journal of pharmaceutics</jtitle><addtitle>Int J Pharm</addtitle><date>2005-03-03</date><risdate>2005</risdate><volume>291</volume><issue>1</issue><spage>59</spage><epage>68</epage><pages>59-68</pages><issn>0378-5173</issn><eissn>1873-3476</eissn><coden>IJPHDE</coden><abstract>Only two crystal forms of pantoprazole sodium, i.e. mono and sesquihydrate, were described in the literature. The objective of the present work was to study the polymorphisms and pseudopolymorphism of pantoprazole sodium and to characterize already known and new crystal forms.
Two additional hydrate forms; i.e. form A, form B and amorphous form were obtained and further characterized by means of thermal analyses, X-ray powder diffraction (XRPD), mid-infrared spectroscopy (IR), near infrared spectroscopy (NIR), Raman spectroscopy, dynamic vapour sorption (DVS), true density, contact angle and solubility. From the results it can be concluded, that the most physically stable form of pantoprazole sodium is form B, whereas form A is the least stable form. Monohydrate and form A are not physically stable and convert into form B from saturated solution/suspension or at high relative humidity. Amorphous form can be obtained by conventional spray drying method or by distillation of solvent under reduced pressure.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>15707732</pmid><doi>10.1016/j.ijpharm.2004.07.043</doi><tpages>10</tpages></addata></record> |
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| subjects | 2-Pyridinylmethylsulfinylbenzimidazoles Benzimidazoles - analysis Benzimidazoles - chemistry Biological and medical sciences Chemistry, Pharmaceutical - methods Chemistry, Pharmaceutical - trends Crystallization - methods Drug Stability Dynamic vapour sorption General pharmacology Infrared spectroscopy Medical sciences Omeprazole - analogs & derivatives Omeprazole - analysis Omeprazole - chemistry Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Physical characterization Pseudopolymorphism Solubility Sulfoxides - analysis Sulfoxides - chemistry Technology, Pharmaceutical - methods Thermal analysis X-ray powder diffraction |
| title | Physical characterization of pantoprazole sodium hydrates |
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