Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation.
Identifieur interne : 000942 ( PubMed/Corpus ); précédent : 000941; suivant : 000943Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation.
Auteurs : Yuh-Fun Maa ; Mahmoud Ameri ; Cassandra Shu ; Lendon G. Payne ; Dexiang ChenSource :
- Journal of pharmaceutical sciences [ 0022-3549 ] ; 2004.
English descriptors
- KwdEn :
- Aerosols, Animals, Chemistry, Pharmaceutical, Drug Evaluation, Preclinical (methods), Drug Stability, Female, Freeze Drying (methods), Humidity (adverse effects), Influenza Vaccines (administration & dosage), Influenza Vaccines (chemistry), Influenza Vaccines (standards), Mice, Mice, Inbred BALB C, Powders.
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , chemistry : Influenza Vaccines.
- chemical , standards : Influenza Vaccines.
- chemical : Aerosols, Powders.
- adverse effects : Humidity.
- methods : Drug Evaluation, Preclinical, Freeze Drying.
- Animals, Chemistry, Pharmaceutical, Drug Stability, Female, Mice, Mice, Inbred BALB C.
Abstract
The purpose of this study was to develop a spray-freeze-drying (SFD) process for preparing an influenza vaccine dry powder formulation suitable for epidermal powder immunization. After preformulation of two types of flu vaccines, their dry-powder formulations were prepared by SFD. Powder properties and physical stability were determined using particle size analysis, tap density measurement, scanning electron microscopy, optical microscopy, and moisture content analysis. Chemical and biochemical stability of vaccine antigens was determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis, single radial immunodiffusion assay, and in vivo immunogenicity in a mouse model. We demonstrated that SFD could produce high-density particles-a critical parameter for effective skin penetration. From the stability perspective, the stress posed by SFD was mild because the antigen in the dry powder retained its stability, potency, and immunogenicity. Among several formulations screened, we noted that formulation composition has a significant role in the powder's long-term physical and biochemical stability. One formulation, in particular, containing sub-unit vaccine (45 microg of antigen in 1 mg of powder) with a tertiary mixture of trehalose, mannitol, and dextran, exhibited excellent overall stability, including acceptable biochemical stability after being exposed to a highly humid environment. After all, we have not only demonstrated the suitability of SFD to prepare powders for epidermal powder immunization but also developed a systematic formulation development strategy that allowed the optimization of an influenza vaccine dry powder formulation. More important, this study led to the selection of a formulation system that had been successfully tested in a human clinical study.
DOI: 10.1002/jps.20104
PubMed: 15176078
Links to Exploration step
pubmed:15176078Le document en format XML
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Payne</name></author><author><name sortKey="Chen, Dexiang" sort="Chen, Dexiang" uniqKey="Chen D" first="Dexiang" last="Chen">Dexiang Chen</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2004">2004</date><idno type="RBID">pubmed:15176078</idno><idno type="pmid">15176078</idno><idno type="doi">10.1002/jps.20104</idno><idno type="wicri:Area/PubMed/Corpus">000942</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000942</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation.</title><author><name sortKey="Maa, Yuh Fun" sort="Maa, Yuh Fun" uniqKey="Maa Y" first="Yuh-Fun" last="Maa">Yuh-Fun Maa</name><affiliation><nlm:affiliation>PowderJect Vaccines, Incorporated, 8551 Research Way Boulevard, Middleton, Wisconsin 53562, USA. ymaa@alzus.jnj.com</nlm:affiliation></affiliation></author><author><name sortKey="Ameri, Mahmoud" sort="Ameri, Mahmoud" uniqKey="Ameri M" first="Mahmoud" last="Ameri">Mahmoud Ameri</name></author><author><name sortKey="Shu, Cassandra" sort="Shu, Cassandra" uniqKey="Shu C" first="Cassandra" last="Shu">Cassandra Shu</name></author><author><name sortKey="Payne, Lendon G" sort="Payne, Lendon G" uniqKey="Payne L" first="Lendon G" last="Payne">Lendon G. Payne</name></author><author><name sortKey="Chen, Dexiang" sort="Chen, Dexiang" uniqKey="Chen D" first="Dexiang" last="Chen">Dexiang Chen</name></author></analytic><series><title level="j">Journal of pharmaceutical sciences</title><idno type="ISSN">0022-3549</idno><imprint><date when="2004" type="published">2004</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aerosols</term><term>Animals</term><term>Chemistry, Pharmaceutical</term><term>Drug Evaluation, Preclinical (methods)</term><term>Drug Stability</term><term>Female</term><term>Freeze Drying (methods)</term><term>Humidity (adverse effects)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (chemistry)</term><term>Influenza Vaccines (standards)</term><term>Mice</term><term>Mice, Inbred BALB C</term><term>Powders</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="chemistry" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="standards" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Aerosols</term><term>Powders</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Humidity</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Drug Evaluation, Preclinical</term><term>Freeze Drying</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Animals</term><term>Chemistry, Pharmaceutical</term><term>Drug Stability</term><term>Female</term><term>Mice</term><term>Mice, Inbred BALB C</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The purpose of this study was to develop a spray-freeze-drying (SFD) process for preparing an influenza vaccine dry powder formulation suitable for epidermal powder immunization. After preformulation of two types of flu vaccines, their dry-powder formulations were prepared by SFD. Powder properties and physical stability were determined using particle size analysis, tap density measurement, scanning electron microscopy, optical microscopy, and moisture content analysis. Chemical and biochemical stability of vaccine antigens was determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis, single radial immunodiffusion assay, and in vivo immunogenicity in a mouse model. We demonstrated that SFD could produce high-density particles-a critical parameter for effective skin penetration. From the stability perspective, the stress posed by SFD was mild because the antigen in the dry powder retained its stability, potency, and immunogenicity. Among several formulations screened, we noted that formulation composition has a significant role in the powder's long-term physical and biochemical stability. One formulation, in particular, containing sub-unit vaccine (45 microg of antigen in 1 mg of powder) with a tertiary mixture of trehalose, mannitol, and dextran, exhibited excellent overall stability, including acceptable biochemical stability after being exposed to a highly humid environment. After all, we have not only demonstrated the suitability of SFD to prepare powders for epidermal powder immunization but also developed a systematic formulation development strategy that allowed the optimization of an influenza vaccine dry powder formulation. More important, this study led to the selection of a formulation system that had been successfully tested in a human clinical study.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">15176078</PMID><DateCompleted><Year>2005</Year><Month>01</Month><Day>18</Day></DateCompleted><DateRevised><Year>2006</Year><Month>11</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0022-3549</ISSN><JournalIssue CitedMedium="Print"><Volume>93</Volume><Issue>7</Issue><PubDate><Year>2004</Year><Month>Jul</Month></PubDate></JournalIssue><Title>Journal of pharmaceutical sciences</Title><ISOAbbreviation>J Pharm Sci</ISOAbbreviation></Journal><ArticleTitle>Influenza vaccine powder formulation development: spray-freeze-drying and stability evaluation.</ArticleTitle><Pagination><MedlinePgn>1912-23</MedlinePgn></Pagination><Abstract><AbstractText>The purpose of this study was to develop a spray-freeze-drying (SFD) process for preparing an influenza vaccine dry powder formulation suitable for epidermal powder immunization. After preformulation of two types of flu vaccines, their dry-powder formulations were prepared by SFD. Powder properties and physical stability were determined using particle size analysis, tap density measurement, scanning electron microscopy, optical microscopy, and moisture content analysis. Chemical and biochemical stability of vaccine antigens was determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis, single radial immunodiffusion assay, and in vivo immunogenicity in a mouse model. We demonstrated that SFD could produce high-density particles-a critical parameter for effective skin penetration. From the stability perspective, the stress posed by SFD was mild because the antigen in the dry powder retained its stability, potency, and immunogenicity. Among several formulations screened, we noted that formulation composition has a significant role in the powder's long-term physical and biochemical stability. One formulation, in particular, containing sub-unit vaccine (45 microg of antigen in 1 mg of powder) with a tertiary mixture of trehalose, mannitol, and dextran, exhibited excellent overall stability, including acceptable biochemical stability after being exposed to a highly humid environment. After all, we have not only demonstrated the suitability of SFD to prepare powders for epidermal powder immunization but also developed a systematic formulation development strategy that allowed the optimization of an influenza vaccine dry powder formulation. More important, this study led to the selection of a formulation system that had been successfully tested in a human clinical study.</AbstractText><CopyrightInformation>Copyright 2004 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 93:1912-1923, 2004</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Maa</LastName><ForeName>Yuh-Fun</ForeName><Initials>YF</Initials><AffiliationInfo><Affiliation>PowderJect Vaccines, Incorporated, 8551 Research Way Boulevard, Middleton, Wisconsin 53562, USA. ymaa@alzus.jnj.com</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ameri</LastName><ForeName>Mahmoud</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Shu</LastName><ForeName>Cassandra</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Payne</LastName><ForeName>Lendon G</ForeName><Initials>LG</Initials></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>Dexiang</ForeName><Initials>D</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Pharm Sci</MedlineTA><NlmUniqueID>2985195R</NlmUniqueID><ISSNLinking>0022-3549</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000336">Aerosols</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007252">Influenza Vaccines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011208">Powders</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000336" MajorTopicYN="N">Aerosols</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000818" MajorTopicYN="N">Animals</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002626" MajorTopicYN="N">Chemistry, Pharmaceutical</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004353" MajorTopicYN="N">Drug Evaluation, Preclinical</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004355" MajorTopicYN="N">Drug Stability</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005612" MajorTopicYN="N">Freeze Drying</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="N">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006813" MajorTopicYN="N">Humidity</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007252" MajorTopicYN="N">Influenza Vaccines</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000737" MajorTopicYN="Y">chemistry</QualifierName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D051379" MajorTopicYN="N">Mice</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008807" MajorTopicYN="N">Mice, Inbred BALB C</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011208" MajorTopicYN="N">Powders</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2004</Year><Month>6</Month><Day>4</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2005</Year><Month>1</Month><Day>19</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2004</Year><Month>6</Month><Day>4</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">15176078</ArticleId><ArticleId IdType="doi">10.1002/jps.20104</ArticleId><ArticleId IdType="pii">S0022-3549(16)31536-2</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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