Development of a spray congealing process for the preparation of insulin-loaded lipid microparticles and characterization thereof
A spray congealing process for the preparation of protein-loaded microparticles was developed. The influence of the process parameters atomization pressure and spraying temperature on particle size and process yield was investigated by experimental design. The employed spray congealing technique ena...
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| Veröffentlicht in: | European journal of pharmaceutics and biopharmaceutics 2007-02, Vol.65 (2), p.175-187 |
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| container_title | European journal of pharmaceutics and biopharmaceutics |
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| creator | Maschke, Angelika Becker, Christian Eyrich, Daniela Kiermaier, Josef Blunk, Torsten Göpferich, Achim |
| description | A spray congealing process for the preparation of protein-loaded microparticles was developed. The influence of the process parameters atomization pressure and spraying temperature on particle size and process yield was investigated by experimental design. The employed spray congealing technique enabled the production of microparticles with yields ranging from 79% to 95% and median particle sizes (
d(0.5)) from 182.2 to 315
μm. Insulin lipid microparticles could be prepared without any loss of insulin during the preparation process and the protein stability was not affected by the spray congealing process as investigated by HPLC-MS analysis. The stability of insulin encapsulated in lipid microparticles under release conditions over 28 days was assessed by investigating the residual insulin content. Starting after 3 days of release, a continuous increase of desamidoinsulin in the remaining particles of up to 7.5% after 28 days was observed. An additional degradation product was detected by HPLC and HPLC-MS analysis and identified as a covalent insulin dimer by MALDI-ToF. The microparticles did not show a burst release and testing the insulin lipid microparticles in a fibrin gel chondrocyte culture revealed that the released insulin was bioactive and had a significant effect on chondrocyte extracellular matrix production. |
| doi_str_mv | 10.1016/j.ejpb.2006.08.008 |
| format | Article |
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d(0.5)) from 182.2 to 315
μm. Insulin lipid microparticles could be prepared without any loss of insulin during the preparation process and the protein stability was not affected by the spray congealing process as investigated by HPLC-MS analysis. The stability of insulin encapsulated in lipid microparticles under release conditions over 28 days was assessed by investigating the residual insulin content. Starting after 3 days of release, a continuous increase of desamidoinsulin in the remaining particles of up to 7.5% after 28 days was observed. An additional degradation product was detected by HPLC and HPLC-MS analysis and identified as a covalent insulin dimer by MALDI-ToF. The microparticles did not show a burst release and testing the insulin lipid microparticles in a fibrin gel chondrocyte culture revealed that the released insulin was bioactive and had a significant effect on chondrocyte extracellular matrix production.</description><identifier>ISSN: 0939-6411</identifier><identifier>EISSN: 1873-3441</identifier><identifier>DOI: 10.1016/j.ejpb.2006.08.008</identifier><identifier>PMID: 17070025</identifier><language>eng</language><publisher>Amsterdam: Elsevier B.V</publisher><subject>Biological and medical sciences ; Cartilage - drug effects ; Cartilage - growth & development ; Cells, Cultured ; Chondrocytes - drug effects ; Controlled release ; Drug Compounding ; Experimental design ; General pharmacology ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - chemistry ; Insulin ; Insulin - administration & dosage ; Insulin - chemistry ; Lipid microparticles ; Lipids ; Medical sciences ; Microspheres ; Particle Size ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; Protein ; Spray congealing ; Temperature ; Triglycerides ; Viscosity</subject><ispartof>European journal of pharmaceutics and biopharmaceutics, 2007-02, Vol.65 (2), p.175-187</ispartof><rights>2006 Elsevier B.V.</rights><rights>2007 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c384t-2bd30c72ddc2f46c4d0330f6a68c12b2e40891bdcab5e15f86e188fe7acf8fff3</citedby><cites>FETCH-LOGICAL-c384t-2bd30c72ddc2f46c4d0330f6a68c12b2e40891bdcab5e15f86e188fe7acf8fff3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ejpb.2006.08.008$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18456903$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17070025$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maschke, Angelika</creatorcontrib><creatorcontrib>Becker, Christian</creatorcontrib><creatorcontrib>Eyrich, Daniela</creatorcontrib><creatorcontrib>Kiermaier, Josef</creatorcontrib><creatorcontrib>Blunk, Torsten</creatorcontrib><creatorcontrib>Göpferich, Achim</creatorcontrib><title>Development of a spray congealing process for the preparation of insulin-loaded lipid microparticles and characterization thereof</title><title>European journal of pharmaceutics and biopharmaceutics</title><addtitle>Eur J Pharm Biopharm</addtitle><description>A spray congealing process for the preparation of protein-loaded microparticles was developed. The influence of the process parameters atomization pressure and spraying temperature on particle size and process yield was investigated by experimental design. The employed spray congealing technique enabled the production of microparticles with yields ranging from 79% to 95% and median particle sizes (
d(0.5)) from 182.2 to 315
μm. Insulin lipid microparticles could be prepared without any loss of insulin during the preparation process and the protein stability was not affected by the spray congealing process as investigated by HPLC-MS analysis. The stability of insulin encapsulated in lipid microparticles under release conditions over 28 days was assessed by investigating the residual insulin content. Starting after 3 days of release, a continuous increase of desamidoinsulin in the remaining particles of up to 7.5% after 28 days was observed. An additional degradation product was detected by HPLC and HPLC-MS analysis and identified as a covalent insulin dimer by MALDI-ToF. The microparticles did not show a burst release and testing the insulin lipid microparticles in a fibrin gel chondrocyte culture revealed that the released insulin was bioactive and had a significant effect on chondrocyte extracellular matrix production.</description><subject>Biological and medical sciences</subject><subject>Cartilage - drug effects</subject><subject>Cartilage - growth & development</subject><subject>Cells, Cultured</subject><subject>Chondrocytes - drug effects</subject><subject>Controlled release</subject><subject>Drug Compounding</subject><subject>Experimental design</subject><subject>General pharmacology</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - chemistry</subject><subject>Insulin</subject><subject>Insulin - administration & dosage</subject><subject>Insulin - chemistry</subject><subject>Lipid microparticles</subject><subject>Lipids</subject><subject>Medical sciences</subject><subject>Microspheres</subject><subject>Particle Size</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>Protein</subject><subject>Spray congealing</subject><subject>Temperature</subject><subject>Triglycerides</subject><subject>Viscosity</subject><issn>0939-6411</issn><issn>1873-3441</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2007</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMFu1DAURS0EosPAD7BA3sAu4TlxHI_EBpUWkCqxKWvLeX5uPUriYGcqlR1_Xo9mpO5YWU8698r3MPZeQC1AqM_7mvbLUDcAqgZdA-gXbCN031atlOIl28Cu3VVKCnHB3uS8BwDZd_o1uxA99ABNt2H_vtEDjXGZaF559NzyvCT7yDHOd2THMN_xJUWknLmPia_3VG5abLJriPMxEeZ8KFw1RuvI8TEswfEpYIqFWgOOlLmdHcf7EsKVUvh7ypauRNG_Za-8HTO9O79b9vv66vbyR3Xz6_vPy683FbZarlUzuBawb5zDxkuF0kHbgldWaRTN0JAEvRODQzt0JDqvFQmtPfUWvfbet1v26dRb9vw5UF7NFDLSONqZ4iEbpSV0oFQBmxNYJuScyJslhcmmRyPAHMWbvTmKN0fxBrQp4kvow7n9MEzkniNn0wX4eAZsRjv6ZGcM-ZnTslO7MmnLvpw4Ki4eAiWTMdCM5EIiXI2L4X__eAIb56Vr</recordid><startdate>20070201</startdate><enddate>20070201</enddate><creator>Maschke, Angelika</creator><creator>Becker, Christian</creator><creator>Eyrich, Daniela</creator><creator>Kiermaier, Josef</creator><creator>Blunk, Torsten</creator><creator>Göpferich, Achim</creator><general>Elsevier B.V</general><general>Elsevier Science</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>20070201</creationdate><title>Development of a spray congealing process for the preparation of insulin-loaded lipid microparticles and characterization thereof</title><author>Maschke, Angelika ; Becker, Christian ; Eyrich, Daniela ; Kiermaier, Josef ; Blunk, Torsten ; Göpferich, Achim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c384t-2bd30c72ddc2f46c4d0330f6a68c12b2e40891bdcab5e15f86e188fe7acf8fff3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2007</creationdate><topic>Biological and medical sciences</topic><topic>Cartilage - drug effects</topic><topic>Cartilage - growth & development</topic><topic>Cells, Cultured</topic><topic>Chondrocytes - drug effects</topic><topic>Controlled release</topic><topic>Drug Compounding</topic><topic>Experimental design</topic><topic>General pharmacology</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - chemistry</topic><topic>Insulin</topic><topic>Insulin - administration & dosage</topic><topic>Insulin - chemistry</topic><topic>Lipid microparticles</topic><topic>Lipids</topic><topic>Medical sciences</topic><topic>Microspheres</topic><topic>Particle Size</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. Drug treatments</topic><topic>Protein</topic><topic>Spray congealing</topic><topic>Temperature</topic><topic>Triglycerides</topic><topic>Viscosity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maschke, Angelika</creatorcontrib><creatorcontrib>Becker, Christian</creatorcontrib><creatorcontrib>Eyrich, Daniela</creatorcontrib><creatorcontrib>Kiermaier, Josef</creatorcontrib><creatorcontrib>Blunk, Torsten</creatorcontrib><creatorcontrib>Göpferich, Achim</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>European journal of pharmaceutics and biopharmaceutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maschke, Angelika</au><au>Becker, Christian</au><au>Eyrich, Daniela</au><au>Kiermaier, Josef</au><au>Blunk, Torsten</au><au>Göpferich, Achim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of a spray congealing process for the preparation of insulin-loaded lipid microparticles and characterization thereof</atitle><jtitle>European journal of pharmaceutics and biopharmaceutics</jtitle><addtitle>Eur J Pharm Biopharm</addtitle><date>2007-02-01</date><risdate>2007</risdate><volume>65</volume><issue>2</issue><spage>175</spage><epage>187</epage><pages>175-187</pages><issn>0939-6411</issn><eissn>1873-3441</eissn><abstract>A spray congealing process for the preparation of protein-loaded microparticles was developed. The influence of the process parameters atomization pressure and spraying temperature on particle size and process yield was investigated by experimental design. The employed spray congealing technique enabled the production of microparticles with yields ranging from 79% to 95% and median particle sizes (
d(0.5)) from 182.2 to 315
μm. Insulin lipid microparticles could be prepared without any loss of insulin during the preparation process and the protein stability was not affected by the spray congealing process as investigated by HPLC-MS analysis. The stability of insulin encapsulated in lipid microparticles under release conditions over 28 days was assessed by investigating the residual insulin content. Starting after 3 days of release, a continuous increase of desamidoinsulin in the remaining particles of up to 7.5% after 28 days was observed. An additional degradation product was detected by HPLC and HPLC-MS analysis and identified as a covalent insulin dimer by MALDI-ToF. The microparticles did not show a burst release and testing the insulin lipid microparticles in a fibrin gel chondrocyte culture revealed that the released insulin was bioactive and had a significant effect on chondrocyte extracellular matrix production.</abstract><cop>Amsterdam</cop><pub>Elsevier B.V</pub><pmid>17070025</pmid><doi>10.1016/j.ejpb.2006.08.008</doi><tpages>13</tpages></addata></record> |
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| identifier | ISSN: 0939-6411 |
| ispartof | European journal of pharmaceutics and biopharmaceutics, 2007-02, Vol.65 (2), p.175-187 |
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| subjects | Biological and medical sciences Cartilage - drug effects Cartilage - growth & development Cells, Cultured Chondrocytes - drug effects Controlled release Drug Compounding Experimental design General pharmacology Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - chemistry Insulin Insulin - administration & dosage Insulin - chemistry Lipid microparticles Lipids Medical sciences Microspheres Particle Size Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments Protein Spray congealing Temperature Triglycerides Viscosity |
| title | Development of a spray congealing process for the preparation of insulin-loaded lipid microparticles and characterization thereof |
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