Solid-State NMR Characterization of High-Loading Solid Solutions of API and Excipients Formed by Electrospinning
A major focus area in improving pharmaceutical manufacturing is decreasing powder-handling steps such as milling, granulation, and blending. One approach to go directly from active pharmaceutical ingredients (API) and excipients in solution to a formulated drug product is to use electrospinning to m...
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| Veröffentlicht in: | Journal of pharmaceutical sciences 2012-04, Vol.101 (4), p.1538-1545 |
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| container_title | Journal of pharmaceutical sciences |
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| creator | Brettmann, Blair Bell, Erin Myerson, Allan Trout, Bernhardt |
| description | A major focus area in improving pharmaceutical manufacturing is decreasing powder-handling steps such as milling, granulation, and blending. One approach to go directly from active pharmaceutical ingredients (API) and excipients in solution to a formulated drug product is to use electrospinning to make solid formulations of API in a polymer. Because of the rapid evaporation rate in electrospinning, the process usually results in a well-mixed solid dispersion of drugs in the polymer. In this study, solid-state nuclear magnetic resonance is used to examine phase separation in formulations of aliskiren (SPP) and indomethacin (IND) with polyvinylpyrrolidone (PVP) prepared by electrospinning and hot-melt extrusion. It was found that 1:1 SPP–PVP, 1:1 IND–PVP, and 4:1 SPP–PVP formulations prepared by electrospinning are homogeneous solid solutions down to a 2–11nm length scale, whereas a 4:1 SPP–PVP formulation prepared by hot-melt extrusion exhibits phase separation with domain sizes of 20–100nm or larger. |
| doi_str_mv | 10.1002/jps.23032 |
| format | Article |
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One approach to go directly from active pharmaceutical ingredients (API) and excipients in solution to a formulated drug product is to use electrospinning to make solid formulations of API in a polymer. Because of the rapid evaporation rate in electrospinning, the process usually results in a well-mixed solid dispersion of drugs in the polymer. In this study, solid-state nuclear magnetic resonance is used to examine phase separation in formulations of aliskiren (SPP) and indomethacin (IND) with polyvinylpyrrolidone (PVP) prepared by electrospinning and hot-melt extrusion. It was found that 1:1 SPP–PVP, 1:1 IND–PVP, and 4:1 SPP–PVP formulations prepared by electrospinning are homogeneous solid solutions down to a 2–11nm length scale, whereas a 4:1 SPP–PVP formulation prepared by hot-melt extrusion exhibits phase separation with domain sizes of 20–100nm or larger.</description><identifier>ISSN: 0022-3549</identifier><identifier>EISSN: 1520-6017</identifier><identifier>DOI: 10.1002/jps.23032</identifier><identifier>PMID: 22213488</identifier><identifier>CODEN: JPMSAE</identifier><language>eng</language><publisher>Hoboken: Elsevier Inc</publisher><subject>Amides - administration & dosage ; amorphous ; Biological and medical sciences ; Chemistry, Pharmaceutical ; Drug Compounding ; electrospinning ; Excipients - administration & dosage ; extrusion ; formulation ; Fumarates - administration & dosage ; General pharmacology ; Indomethacin - administration & dosage ; Magnetic Resonance Spectroscopy - methods ; Medical sciences ; Pharmaceutical technology. 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Drug treatments ; Povidone - administration & dosage ; relaxation time ; solid dosage form ; solid solutions ; solid-state NMR ; Solutions</subject><ispartof>Journal of pharmaceutical sciences, 2012-04, Vol.101 (4), p.1538-1545</ispartof><rights>2012 Wiley Periodicals, Inc.</rights><rights>Copyright © 2011 Wiley Periodicals, Inc.</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4642-f6ca3cb8b6be0b273ce5ee376c8da194ca71b1f893860eff6ec9ad4ba600c8343</citedby><cites>FETCH-LOGICAL-c4642-f6ca3cb8b6be0b273ce5ee376c8da194ca71b1f893860eff6ec9ad4ba600c8343</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.23032$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjps.23032$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,777,781,1412,27905,27906,45555,45556</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25641894$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22213488$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Brettmann, Blair</creatorcontrib><creatorcontrib>Bell, Erin</creatorcontrib><creatorcontrib>Myerson, Allan</creatorcontrib><creatorcontrib>Trout, Bernhardt</creatorcontrib><title>Solid-State NMR Characterization of High-Loading Solid Solutions of API and Excipients Formed by Electrospinning</title><title>Journal of pharmaceutical sciences</title><addtitle>J. Pharm. Sci</addtitle><description>A major focus area in improving pharmaceutical manufacturing is decreasing powder-handling steps such as milling, granulation, and blending. One approach to go directly from active pharmaceutical ingredients (API) and excipients in solution to a formulated drug product is to use electrospinning to make solid formulations of API in a polymer. Because of the rapid evaporation rate in electrospinning, the process usually results in a well-mixed solid dispersion of drugs in the polymer. In this study, solid-state nuclear magnetic resonance is used to examine phase separation in formulations of aliskiren (SPP) and indomethacin (IND) with polyvinylpyrrolidone (PVP) prepared by electrospinning and hot-melt extrusion. It was found that 1:1 SPP–PVP, 1:1 IND–PVP, and 4:1 SPP–PVP formulations prepared by electrospinning are homogeneous solid solutions down to a 2–11nm length scale, whereas a 4:1 SPP–PVP formulation prepared by hot-melt extrusion exhibits phase separation with domain sizes of 20–100nm or larger.</description><subject>Amides - administration & dosage</subject><subject>amorphous</subject><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical</subject><subject>Drug Compounding</subject><subject>electrospinning</subject><subject>Excipients - administration & dosage</subject><subject>extrusion</subject><subject>formulation</subject><subject>Fumarates - administration & dosage</subject><subject>General pharmacology</subject><subject>Indomethacin - administration & dosage</subject><subject>Magnetic Resonance Spectroscopy - methods</subject><subject>Medical sciences</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Povidone - administration & dosage</subject><subject>relaxation time</subject><subject>solid dosage form</subject><subject>solid solutions</subject><subject>solid-state NMR</subject><subject>Solutions</subject><issn>0022-3549</issn><issn>1520-6017</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUtv1DAUhS0EokNhwR9AkVCFukjrd5JlNZo-0FCqThHsLMe5aT1k4mAntMOvxzOZFgnBxl7c75z7OAi9JfiIYEyPl104ogwz-gxNiKA4lZhkz9Ek1mjKBC_20KsQlhhjiYV4ifYopYTxPJ-gbuEaW6WLXveQXH66TqZ32mvTg7e_dG9dm7g6Obe3d-nc6cq2t8lWsHmHTTls6idXF4luq2T2YGxnoe1Dcur8CqqkXCezBkzvXehs20b9a_Si1k2AN7t_H305nd1Mz9P557OL6ck8NVxymtbSaGbKvJQl4JJmzIAAYJk0eaVJwY3OSEnqvGC5xFDXEkyhK15qibHJGWf76MPo23n3Y4DQq5UNBppGt-CGoArKCkE4J5F8_xe5dINv43CKCJKxgrOt3-FImbhL8FCrztuV9mtFsNqkoGIKaptCZN_tHIcyXuGJfDx7BA52gA5GN7XXrbHhDyckJ3mxaXo8cve2gfX_O6qPV4vH1umosKGHhyeF9t-VzFgm1NfLMyW-5TfkOuOKRZ6NPMQsflrwKpiYoIHK-pibqpz9x4K_AVFvvoE</recordid><startdate>201204</startdate><enddate>201204</enddate><creator>Brettmann, Blair</creator><creator>Bell, Erin</creator><creator>Myerson, Allan</creator><creator>Trout, Bernhardt</creator><general>Elsevier Inc</general><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley</general><general>American Pharmaceutical Association</general><general>Elsevier Limited</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>7QO</scope><scope>7QP</scope><scope>7QR</scope><scope>7TK</scope><scope>7U7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope></search><sort><creationdate>201204</creationdate><title>Solid-State NMR Characterization of High-Loading Solid Solutions of API and Excipients Formed by Electrospinning</title><author>Brettmann, Blair ; Bell, Erin ; Myerson, Allan ; Trout, Bernhardt</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4642-f6ca3cb8b6be0b273ce5ee376c8da194ca71b1f893860eff6ec9ad4ba600c8343</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Amides - administration & dosage</topic><topic>amorphous</topic><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical</topic><topic>Drug Compounding</topic><topic>electrospinning</topic><topic>Excipients - administration & dosage</topic><topic>extrusion</topic><topic>formulation</topic><topic>Fumarates - administration & dosage</topic><topic>General pharmacology</topic><topic>Indomethacin - administration & dosage</topic><topic>Magnetic Resonance Spectroscopy - methods</topic><topic>Medical sciences</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. 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| subjects | Amides - administration & dosage amorphous Biological and medical sciences Chemistry, Pharmaceutical Drug Compounding electrospinning Excipients - administration & dosage extrusion formulation Fumarates - administration & dosage General pharmacology Indomethacin - administration & dosage Magnetic Resonance Spectroscopy - methods Medical sciences Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Povidone - administration & dosage relaxation time solid dosage form solid solutions solid-state NMR Solutions |
| title | Solid-State NMR Characterization of High-Loading Solid Solutions of API and Excipients Formed by Electrospinning |
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