Effect of Polymer Size and Cosolutes on Phase Separation of Poly(Vinylpyrrolidone) (PVP) and Dextran in Frozen Solutions
The aim of this study was to elucidate the effect of the molecular weight of polymers on their miscibility in frozen solutions to model the physical properties of freeze-dried pharmaceutical formulations. Thermal analysis of frozen solutions containing poly(vinylpyrrolidone) (PVP) and dextran of var...
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| Veröffentlicht in: | Journal of pharmaceutical sciences 2005-04, Vol.94 (4), p.709-717 |
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| creator | Izutsu, Ken-ichi Aoyagi, Nobuo Kojima, Shigeo |
| description | The aim of this study was to elucidate the effect of the molecular weight of polymers on their miscibility in frozen solutions to model the physical properties of freeze-dried pharmaceutical formulations. Thermal analysis of frozen solutions containing poly(vinylpyrrolidone) (PVP) and dextran of various molecular weights was performed at polymer concentrations below the binodal curve at room temperature. Frozen solutions containing PVP 29,000 and dextran 10,200 showed two thermal transitions (glass transition temperature of maximally freeze-concentrated solution: Tg′) representing two freeze-concentrated amorphous phases, each containing predominantly one of the polymers. A combination of smaller polymers (PVP 10,000 and dextran 1,060) was freeze-concentrated into an amorphous mixture phase across a wide range of concentration ratios. Combinations of intermediate size polymers separated into two freeze-concentrated phases only at certain concentration ratios. Addition of NaCl prevented the phase separation of PVP and dextran in the aqueous and frozen solutions. Higher concentrations of NaCl were required to retain the miscibility of larger polymer combinations in the freeze-concentrate. The molecular weights of the component polymers, polymer concentration ratio, and cosolute composition are the important factors that determine component miscibility in frozen solutions. |
| doi_str_mv | 10.1002/jps.20292 |
| format | Article |
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Thermal analysis of frozen solutions containing poly(vinylpyrrolidone) (PVP) and dextran of various molecular weights was performed at polymer concentrations below the binodal curve at room temperature. Frozen solutions containing PVP 29,000 and dextran 10,200 showed two thermal transitions (glass transition temperature of maximally freeze-concentrated solution: Tg′) representing two freeze-concentrated amorphous phases, each containing predominantly one of the polymers. A combination of smaller polymers (PVP 10,000 and dextran 1,060) was freeze-concentrated into an amorphous mixture phase across a wide range of concentration ratios. Combinations of intermediate size polymers separated into two freeze-concentrated phases only at certain concentration ratios. Addition of NaCl prevented the phase separation of PVP and dextran in the aqueous and frozen solutions. Higher concentrations of NaCl were required to retain the miscibility of larger polymer combinations in the freeze-concentrate. The molecular weights of the component polymers, polymer concentration ratio, and cosolute composition are the important factors that determine component miscibility in frozen solutions.</description><identifier>ISSN: 0022-3549</identifier><identifier>EISSN: 1520-6017</identifier><identifier>DOI: 10.1002/jps.20292</identifier><identifier>PMID: 15682383</identifier><identifier>CODEN: JPMSAE</identifier><language>eng</language><publisher>Hoboken: Elsevier Inc</publisher><subject>amorphous ; Biological and medical sciences ; calorimetry (DSC) ; Calorimetry, Differential Scanning ; Chemical Phenomena ; Chemistry, Physical ; Dextrans - isolation & purification ; freeze concentration ; freeze drying ; Freezing ; General pharmacology ; Medical sciences ; Molecular Weight ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; phase separation ; physical characterization ; Povidone - isolation & purification ; protein formulation excipients ; Sodium Chloride - chemistry ; Solubility ; Solutions ; Temperature ; Viscosity</subject><ispartof>Journal of pharmaceutical sciences, 2005-04, Vol.94 (4), p.709-717</ispartof><rights>2005 Wiley-Liss, Inc.</rights><rights>Copyright © 2005 Wiley‐Liss, Inc.</rights><rights>2005 INIST-CNRS</rights><rights>Copyright (c) 2004 Wiley-Liss, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5012-1846fbd98ee4db5ffffd7b2f9d5199d4e017ddde1ee3b7d33eef951dd1ec9c923</citedby><cites>FETCH-LOGICAL-c5012-1846fbd98ee4db5ffffd7b2f9d5199d4e017ddde1ee3b7d33eef951dd1ec9c923</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fjps.20292$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjps.20292$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16678291$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15682383$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Izutsu, Ken-ichi</creatorcontrib><creatorcontrib>Aoyagi, Nobuo</creatorcontrib><creatorcontrib>Kojima, Shigeo</creatorcontrib><title>Effect of Polymer Size and Cosolutes on Phase Separation of Poly(Vinylpyrrolidone) (PVP) and Dextran in Frozen Solutions</title><title>Journal of pharmaceutical sciences</title><addtitle>J. Pharm. Sci</addtitle><description>The aim of this study was to elucidate the effect of the molecular weight of polymers on their miscibility in frozen solutions to model the physical properties of freeze-dried pharmaceutical formulations. Thermal analysis of frozen solutions containing poly(vinylpyrrolidone) (PVP) and dextran of various molecular weights was performed at polymer concentrations below the binodal curve at room temperature. Frozen solutions containing PVP 29,000 and dextran 10,200 showed two thermal transitions (glass transition temperature of maximally freeze-concentrated solution: Tg′) representing two freeze-concentrated amorphous phases, each containing predominantly one of the polymers. A combination of smaller polymers (PVP 10,000 and dextran 1,060) was freeze-concentrated into an amorphous mixture phase across a wide range of concentration ratios. Combinations of intermediate size polymers separated into two freeze-concentrated phases only at certain concentration ratios. Addition of NaCl prevented the phase separation of PVP and dextran in the aqueous and frozen solutions. Higher concentrations of NaCl were required to retain the miscibility of larger polymer combinations in the freeze-concentrate. The molecular weights of the component polymers, polymer concentration ratio, and cosolute composition are the important factors that determine component miscibility in frozen solutions.</description><subject>amorphous</subject><subject>Biological and medical sciences</subject><subject>calorimetry (DSC)</subject><subject>Calorimetry, Differential Scanning</subject><subject>Chemical Phenomena</subject><subject>Chemistry, Physical</subject><subject>Dextrans - isolation & purification</subject><subject>freeze concentration</subject><subject>freeze drying</subject><subject>Freezing</subject><subject>General pharmacology</subject><subject>Medical sciences</subject><subject>Molecular Weight</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>phase separation</subject><subject>physical characterization</subject><subject>Povidone - isolation & purification</subject><subject>protein formulation excipients</subject><subject>Sodium Chloride - chemistry</subject><subject>Solubility</subject><subject>Solutions</subject><subject>Temperature</subject><subject>Viscosity</subject><issn>0022-3549</issn><issn>1520-6017</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUFv1DAUhC0EokvhwB9AvoC6h7S2EyfxES3dAioQaWHLzXLsF-GSjYOdhU1_PW4T6AV8seT3zTzNGKHnlJxSQtjZdR9OGWGCPUALyhlJckKLh2gRZyxJeSaO0JMQrgkhOeH8MTqiPC9ZWqYLdDhvGtADdg2uXDvuwOONvQGsOoNXLrh2P0DArsPVNxUAb6BXXg02PsyKk63txrYfvXetNa6DJT6pttXyzuENHAavOmw7vPbuBjq8uXWM8vAUPWpUG-DZfB-jL-vzz6u3yeWni3er15eJ5oSyhJZZ3tRGlACZqXkTjylq1gjDqRAmg5jUGAMUIK0Lk6YAjeDUGApaaMHSY_Rq8u29-7GHMMidDRraVnXg9kHmRVZwIXgElxOovQvBQyN7b3fKj5ISeVuzjDXLu5oj-2I23dc7MPfk3GsEXs6AClq1TSxB23DP5XlRMkEjdzZxv2wL4_83yvfV5s_qZFLYMMDhr0L57zFKWnB59fFCltXXD1txtZZV5NOJh1jyTwteBm2h02Csjx8vjbP_CPgb3vC2vQ</recordid><startdate>200504</startdate><enddate>200504</enddate><creator>Izutsu, Ken-ichi</creator><creator>Aoyagi, Nobuo</creator><creator>Kojima, Shigeo</creator><general>Elsevier Inc</general><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley</general><general>American Pharmaceutical Association</general><scope>BSCLL</scope><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>200504</creationdate><title>Effect of Polymer Size and Cosolutes on Phase Separation of Poly(Vinylpyrrolidone) (PVP) and Dextran in Frozen Solutions</title><author>Izutsu, Ken-ichi ; Aoyagi, Nobuo ; Kojima, Shigeo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5012-1846fbd98ee4db5ffffd7b2f9d5199d4e017ddde1ee3b7d33eef951dd1ec9c923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>amorphous</topic><topic>Biological and medical sciences</topic><topic>calorimetry (DSC)</topic><topic>Calorimetry, Differential Scanning</topic><topic>Chemical Phenomena</topic><topic>Chemistry, Physical</topic><topic>Dextrans - isolation & purification</topic><topic>freeze concentration</topic><topic>freeze drying</topic><topic>Freezing</topic><topic>General pharmacology</topic><topic>Medical sciences</topic><topic>Molecular Weight</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>phase separation</topic><topic>physical characterization</topic><topic>Povidone - isolation & purification</topic><topic>protein formulation excipients</topic><topic>Sodium Chloride - chemistry</topic><topic>Solubility</topic><topic>Solutions</topic><topic>Temperature</topic><topic>Viscosity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Izutsu, Ken-ichi</creatorcontrib><creatorcontrib>Aoyagi, Nobuo</creatorcontrib><creatorcontrib>Kojima, Shigeo</creatorcontrib><collection>Istex</collection><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>Journal of pharmaceutical sciences</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Izutsu, Ken-ichi</au><au>Aoyagi, Nobuo</au><au>Kojima, Shigeo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of Polymer Size and Cosolutes on Phase Separation of Poly(Vinylpyrrolidone) (PVP) and Dextran in Frozen Solutions</atitle><jtitle>Journal of pharmaceutical sciences</jtitle><addtitle>J. Pharm. Sci</addtitle><date>2005-04</date><risdate>2005</risdate><volume>94</volume><issue>4</issue><spage>709</spage><epage>717</epage><pages>709-717</pages><issn>0022-3549</issn><eissn>1520-6017</eissn><coden>JPMSAE</coden><abstract>The aim of this study was to elucidate the effect of the molecular weight of polymers on their miscibility in frozen solutions to model the physical properties of freeze-dried pharmaceutical formulations. Thermal analysis of frozen solutions containing poly(vinylpyrrolidone) (PVP) and dextran of various molecular weights was performed at polymer concentrations below the binodal curve at room temperature. Frozen solutions containing PVP 29,000 and dextran 10,200 showed two thermal transitions (glass transition temperature of maximally freeze-concentrated solution: Tg′) representing two freeze-concentrated amorphous phases, each containing predominantly one of the polymers. A combination of smaller polymers (PVP 10,000 and dextran 1,060) was freeze-concentrated into an amorphous mixture phase across a wide range of concentration ratios. Combinations of intermediate size polymers separated into two freeze-concentrated phases only at certain concentration ratios. Addition of NaCl prevented the phase separation of PVP and dextran in the aqueous and frozen solutions. Higher concentrations of NaCl were required to retain the miscibility of larger polymer combinations in the freeze-concentrate. The molecular weights of the component polymers, polymer concentration ratio, and cosolute composition are the important factors that determine component miscibility in frozen solutions.</abstract><cop>Hoboken</cop><pub>Elsevier Inc</pub><pmid>15682383</pmid><doi>10.1002/jps.20292</doi><tpages>9</tpages></addata></record> |
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| subjects | amorphous Biological and medical sciences calorimetry (DSC) Calorimetry, Differential Scanning Chemical Phenomena Chemistry, Physical Dextrans - isolation & purification freeze concentration freeze drying Freezing General pharmacology Medical sciences Molecular Weight Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments phase separation physical characterization Povidone - isolation & purification protein formulation excipients Sodium Chloride - chemistry Solubility Solutions Temperature Viscosity |
| title | Effect of Polymer Size and Cosolutes on Phase Separation of Poly(Vinylpyrrolidone) (PVP) and Dextran in Frozen Solutions |
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