Aluminum Adjuvant Dose Guidelines in Vaccine Formulation for Preclinical Evaluations
Aluminum (Al) salt-based adjuvants are present in a large variety of licensed vaccines and their use is widely considered for formulations in clinical trials. Although the regulatory agencies have clearly stated the acceptable levels of Al salts in vaccines for human use, there are no general indica...
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| Veröffentlicht in: | Journal of pharmaceutical sciences 2012-01, Vol.101 (1), p.17-20 |
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| container_title | Journal of pharmaceutical sciences |
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| creator | Vecchi, Simone Bufali, Simone Skibinski, David A.G. O'hagan, Derek T. Singh, Manmohan |
| description | Aluminum (Al) salt-based adjuvants are present in a large variety of licensed vaccines and their use is widely considered for formulations in clinical trials. Although the regulatory agencies have clearly stated the acceptable levels of Al salts in vaccines for human use, there are no general indications for preclinical research. This brief commentary reviews the current status of Al concentrations in licensed vaccines, the related potential toxicity in preclinical species, and proposes a general guideline for selection of suitable Al salt levels in preclinical models, focusing on the formulation development for recombinant protein antigens. A table with conversion factors is included in order to provide a tool for calculation of doses with different Al salts. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association. |
| doi_str_mv | 10.1002/jps.22759 |
| format | Article |
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Although the regulatory agencies have clearly stated the acceptable levels of Al salts in vaccines for human use, there are no general indications for preclinical research. This brief commentary reviews the current status of Al concentrations in licensed vaccines, the related potential toxicity in preclinical species, and proposes a general guideline for selection of suitable Al salt levels in preclinical models, focusing on the formulation development for recombinant protein antigens. A table with conversion factors is included in order to provide a tool for calculation of doses with different Al salts. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association.</description><identifier>ISSN: 0022-3549</identifier><identifier>EISSN: 1520-6017</identifier><identifier>DOI: 10.1002/jps.22759</identifier><identifier>PMID: 21918987</identifier><identifier>CODEN: JPMSAE</identifier><language>eng</language><publisher>Hoboken: Elsevier Inc</publisher><subject>Adjuvants, Immunologic - administration & dosage ; Adjuvants, Immunologic - chemistry ; Adjuvants, Immunologic - standards ; Aluminum - administration & dosage ; Aluminum - adverse effects ; Aluminum - chemistry ; Aluminum - standards ; Animals ; Biological and medical sciences ; Chemistry, Pharmaceutical - methods ; Drug Evaluation, Preclinical - methods ; General pharmacology ; Humans ; injectables ; Medical sciences ; Pharmaceutical technology. Pharmaceutical industry ; Pharmacology. Drug treatments ; preformulation ; protein formulation ; vaccine adjuvants ; vaccines ; Vaccines - administration & dosage ; Vaccines - chemistry ; Vaccines - standards</subject><ispartof>Journal of pharmaceutical sciences, 2012-01, Vol.101 (1), p.17-20</ispartof><rights>2012 Wiley-Liss, Inc.</rights><rights>Copyright © 2011 Wiley‐Liss, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Wiley-Liss, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4649-8b7fe40edcd438a7c5ae0050de257e85ebd0616c1b405fb58d69d6a29418d80c3</citedby><cites>FETCH-LOGICAL-c4649-8b7fe40edcd438a7c5ae0050de257e85ebd0616c1b405fb58d69d6a29418d80c3</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.22759$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fjps.22759$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,4024,27923,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=25505689$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21918987$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vecchi, Simone</creatorcontrib><creatorcontrib>Bufali, Simone</creatorcontrib><creatorcontrib>Skibinski, David A.G.</creatorcontrib><creatorcontrib>O'hagan, Derek T.</creatorcontrib><creatorcontrib>Singh, Manmohan</creatorcontrib><title>Aluminum Adjuvant Dose Guidelines in Vaccine Formulation for Preclinical Evaluations</title><title>Journal of pharmaceutical sciences</title><addtitle>J. Pharm. Sci</addtitle><description>Aluminum (Al) salt-based adjuvants are present in a large variety of licensed vaccines and their use is widely considered for formulations in clinical trials. Although the regulatory agencies have clearly stated the acceptable levels of Al salts in vaccines for human use, there are no general indications for preclinical research. This brief commentary reviews the current status of Al concentrations in licensed vaccines, the related potential toxicity in preclinical species, and proposes a general guideline for selection of suitable Al salt levels in preclinical models, focusing on the formulation development for recombinant protein antigens. A table with conversion factors is included in order to provide a tool for calculation of doses with different Al salts. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association.</description><subject>Adjuvants, Immunologic - administration & dosage</subject><subject>Adjuvants, Immunologic - chemistry</subject><subject>Adjuvants, Immunologic - standards</subject><subject>Aluminum - administration & dosage</subject><subject>Aluminum - adverse effects</subject><subject>Aluminum - chemistry</subject><subject>Aluminum - standards</subject><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>Chemistry, Pharmaceutical - methods</subject><subject>Drug Evaluation, Preclinical - methods</subject><subject>General pharmacology</subject><subject>Humans</subject><subject>injectables</subject><subject>Medical sciences</subject><subject>Pharmaceutical technology. Pharmaceutical industry</subject><subject>Pharmacology. Drug treatments</subject><subject>preformulation</subject><subject>protein formulation</subject><subject>vaccine adjuvants</subject><subject>vaccines</subject><subject>Vaccines - administration & dosage</subject><subject>Vaccines - chemistry</subject><subject>Vaccines - standards</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>eNp1kU1v1DAQhi0EokvhwB9AkRAHDmnHSfyR46p0l48KVmIpR8uxJ5KXfCx2vNB_j9tsywVOM9I8876adwh5SeGMAhTnu304KwrB6kdkQVkBOQcqHpNFmhV5yar6hDwLYQcAHBh7Sk4KWlNZS7Eg22UXezfEPlvaXTzoYcrejQGzdXQWOzdgyNyQXWtjUp-tRt_HTk9uHLJ29NnGo0mQM7rLLg-6i3ej8Jw8aXUX8MWxnpJvq8vtxfv86sv6w8XyKjcVr-pcNqLFCtAaW5VSC8M0AjCwWDCBkmFjgVNuaFMBaxsmLa8t10VdUWklmPKUvJ519378GTFMajdGPyRLRRkVpZS05Il6O1PGjyF4bNXeu177G0VB3eanUn7qLr_EvjoqxqZH-0DeB5aAN0dAh3R16_VgXPjLMQaMy1uh85n75Tq8-b-j-rj5em-dzxsuTPj7YUP7H4qLUjD1_fNabVdb2FxXtfqU-HLmMSV8cOhVMA4Hg9alr0zKju4fB_4BEwGnrg</recordid><startdate>201201</startdate><enddate>201201</enddate><creator>Vecchi, Simone</creator><creator>Bufali, Simone</creator><creator>Skibinski, David A.G.</creator><creator>O'hagan, Derek T.</creator><creator>Singh, Manmohan</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></search><sort><creationdate>201201</creationdate><title>Aluminum Adjuvant Dose Guidelines in Vaccine Formulation for Preclinical Evaluations</title><author>Vecchi, Simone ; Bufali, Simone ; Skibinski, David A.G. ; O'hagan, Derek T. ; Singh, Manmohan</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4649-8b7fe40edcd438a7c5ae0050de257e85ebd0616c1b405fb58d69d6a29418d80c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Adjuvants, Immunologic - administration & dosage</topic><topic>Adjuvants, Immunologic - chemistry</topic><topic>Adjuvants, Immunologic - standards</topic><topic>Aluminum - administration & dosage</topic><topic>Aluminum - adverse effects</topic><topic>Aluminum - chemistry</topic><topic>Aluminum - standards</topic><topic>Animals</topic><topic>Biological and medical sciences</topic><topic>Chemistry, Pharmaceutical - methods</topic><topic>Drug Evaluation, Preclinical - methods</topic><topic>General pharmacology</topic><topic>Humans</topic><topic>injectables</topic><topic>Medical sciences</topic><topic>Pharmaceutical technology. Pharmaceutical industry</topic><topic>Pharmacology. 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Pharm. Sci</addtitle><date>2012-01</date><risdate>2012</risdate><volume>101</volume><issue>1</issue><spage>17</spage><epage>20</epage><pages>17-20</pages><issn>0022-3549</issn><eissn>1520-6017</eissn><coden>JPMSAE</coden><abstract>Aluminum (Al) salt-based adjuvants are present in a large variety of licensed vaccines and their use is widely considered for formulations in clinical trials. Although the regulatory agencies have clearly stated the acceptable levels of Al salts in vaccines for human use, there are no general indications for preclinical research. This brief commentary reviews the current status of Al concentrations in licensed vaccines, the related potential toxicity in preclinical species, and proposes a general guideline for selection of suitable Al salt levels in preclinical models, focusing on the formulation development for recombinant protein antigens. 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| subjects | Adjuvants, Immunologic - administration & dosage Adjuvants, Immunologic - chemistry Adjuvants, Immunologic - standards Aluminum - administration & dosage Aluminum - adverse effects Aluminum - chemistry Aluminum - standards Animals Biological and medical sciences Chemistry, Pharmaceutical - methods Drug Evaluation, Preclinical - methods General pharmacology Humans injectables Medical sciences Pharmaceutical technology. Pharmaceutical industry Pharmacology. Drug treatments preformulation protein formulation vaccine adjuvants vaccines Vaccines - administration & dosage Vaccines - chemistry Vaccines - standards |
| title | Aluminum Adjuvant Dose Guidelines in Vaccine Formulation for Preclinical Evaluations |
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