Development of an Improved Inhalable Powder Formulation of Pirfenidone by Spray-Drying: In Vitro Characterization and Pharmacokinetic Profiling
Purpose Previously, a respirable powder (RP) formulation of pirfenidone (PFD) was developed for reducing phototoxic risk; however, PFD-RP demonstrated unacceptable in vitro inhalation performance. The present study aimed to develop a new RP system of PFD with favorable inhalation properties by spray...
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| Veröffentlicht in: | Pharmaceutical research 2016-06, Vol.33 (6), p.1447-1455 |
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| creator | Seto, Yoshiki Suzuki, Gen Leung, Sharon Shui Yee Chan, Hak-Kim Onoue, Satomi |
| description | Purpose
Previously, a respirable powder (RP) formulation of pirfenidone (PFD) was developed for reducing phototoxic risk; however, PFD-RP demonstrated unacceptable
in vitro
inhalation performance. The present study aimed to develop a new RP system of PFD with favorable inhalation properties by spray-drying method.
Methods
Spray-dried PFD (SD/PFD) was prepared by spray-drying with L-leucine, and the physicochemical properties and efficacy in an antigen-sensitized airway inflammation model were assessed. A pharmacokinetic study was also conducted after intratracheal and oral administration of PFD formulations.
Results
Regarding powder characterization, SD/PFD had dimpled surface with the mean diameter of 1.793 μm. In next generation impactor analysis, SD/PFD demonstrated high
in vitro
inhalation performance without the need of carrier particles, and the fine particle fraction of SD/PFD was calculated to be 62.4%. Insufflated SD/PFD (0.3 mg-PFD/rat) attenuated antigen-evoked inflammatory events in the lung, including infiltration of inflammatory cells and myeloperoxidase activity. Systemic exposure level of PFD after insufflation of SD/PFD at the pharmacologically effective dose was 600-fold lower than that after oral administration of PFD at the phototoxic dose.
Conclusion
SD/PFD would be suitable for inhalation, and the utilization of an RP system with SD/PFD would provide a safer medication compared with oral administration of PFD. |
| doi_str_mv | 10.1007/s11095-016-1887-3 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_miscellaneous_1787095342</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A747438891</galeid><sourcerecordid>A747438891</sourcerecordid><originalsourceid>FETCH-LOGICAL-c439t-c2d1ba9a21958fe9264de3a68e7552e3667e9da179ee97db96d59b94e7e7428f3</originalsourceid><addsrcrecordid>eNp1ks1u1DAUhS0EotPCA7BBltiwSbFjJ7bZVVMKI1ViJH7EznLim6lLYg92UjR9CV4ZRym_Anlhyfc7V-deH4SeUHJKCREvEqVEVQWhdUGlFAW7h1a0EqxQhH-6j1ZElLyQgtMjdJzSNSFEUsUfoqOyVqJiNVmhb-dwA33YD-BHHDpsPN4M-xhuwOKNvzK9aXrA2_DVQsQXIQ5Tb0YX_MxuXezAOxs84OaA3-2jORTn8eD87mUW449ujAGvr0w07QjR3S5K4y3e5sfBtOGz8zC6Fm9j6FyfhY_Qg870CR7f3Sfow8Wr9-s3xeXb15v12WXRcqbGoi0tbYwyJVWV7ECVNbfATC1BVFUJrK4FKGuoUABK2EbVtlKN4iBA8FJ27AQ9X_rmWb9MkEY9uNRC3xsPYUqaCinybhkvM_rsL_Q6TNFndzNVqUopzn5RO9ODdr4LYx57bqrPBBecSalopk7_QeVjYXBtXmTeAvwpoIugjSGlCJ3eRzeYeNCU6DkEegmBziHQcwj0bOXpneGpGcD-VPz49QyUC5Byye8g_jbRf7t-BwG3vPo</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1785959943</pqid></control><display><type>article</type><title>Development of an Improved Inhalable Powder Formulation of Pirfenidone by Spray-Drying: In Vitro Characterization and Pharmacokinetic Profiling</title><source>MEDLINE</source><source>SpringerLink Journals - AutoHoldings</source><creator>Seto, Yoshiki ; Suzuki, Gen ; Leung, Sharon Shui Yee ; Chan, Hak-Kim ; Onoue, Satomi</creator><creatorcontrib>Seto, Yoshiki ; Suzuki, Gen ; Leung, Sharon Shui Yee ; Chan, Hak-Kim ; Onoue, Satomi</creatorcontrib><description>Purpose
Previously, a respirable powder (RP) formulation of pirfenidone (PFD) was developed for reducing phototoxic risk; however, PFD-RP demonstrated unacceptable
in vitro
inhalation performance. The present study aimed to develop a new RP system of PFD with favorable inhalation properties by spray-drying method.
Methods
Spray-dried PFD (SD/PFD) was prepared by spray-drying with L-leucine, and the physicochemical properties and efficacy in an antigen-sensitized airway inflammation model were assessed. A pharmacokinetic study was also conducted after intratracheal and oral administration of PFD formulations.
Results
Regarding powder characterization, SD/PFD had dimpled surface with the mean diameter of 1.793 μm. In next generation impactor analysis, SD/PFD demonstrated high
in vitro
inhalation performance without the need of carrier particles, and the fine particle fraction of SD/PFD was calculated to be 62.4%. Insufflated SD/PFD (0.3 mg-PFD/rat) attenuated antigen-evoked inflammatory events in the lung, including infiltration of inflammatory cells and myeloperoxidase activity. Systemic exposure level of PFD after insufflation of SD/PFD at the pharmacologically effective dose was 600-fold lower than that after oral administration of PFD at the phototoxic dose.
Conclusion
SD/PFD would be suitable for inhalation, and the utilization of an RP system with SD/PFD would provide a safer medication compared with oral administration of PFD.</description><identifier>ISSN: 0724-8741</identifier><identifier>EISSN: 1573-904X</identifier><identifier>DOI: 10.1007/s11095-016-1887-3</identifier><identifier>PMID: 26975360</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Administration, Inhalation ; Administration, Oral ; Aerosols ; Analysis ; Animals ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - chemistry ; Anti-Inflammatory Agents - pharmacokinetics ; Anti-Inflammatory Agents - toxicity ; Antigens ; Biochemistry ; Biomedical and Life Sciences ; Biomedical Engineering and Bioengineering ; Biomedicine ; Bronchoalveolar Lavage Fluid - immunology ; Chromatography, Liquid ; Desiccation ; Disease Models, Animal ; Drug Compounding ; Inflammation ; Kinetics ; Male ; Medical Law ; Ovalbumin ; Particle Size ; Peroxidase - metabolism ; Pharmacology ; Pharmacology/Toxicology ; Pharmacy ; Pneumonia - blood ; Pneumonia - chemically induced ; Pneumonia - immunology ; Pneumonia - prevention & control ; Powders ; Pyridones - administration & dosage ; Pyridones - chemistry ; Pyridones - pharmacokinetics ; Pyridones - toxicity ; Rats, Sprague-Dawley ; Research Paper ; Respiratory therapy ; Spectrometry, Mass, Electrospray Ionization ; Technology, Pharmaceutical - methods ; Thrombosis</subject><ispartof>Pharmaceutical research, 2016-06, Vol.33 (6), p.1447-1455</ispartof><rights>Springer Science+Business Media New York 2016</rights><rights>COPYRIGHT 2016 Springer</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c439t-c2d1ba9a21958fe9264de3a68e7552e3667e9da179ee97db96d59b94e7e7428f3</citedby><cites>FETCH-LOGICAL-c439t-c2d1ba9a21958fe9264de3a68e7552e3667e9da179ee97db96d59b94e7e7428f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11095-016-1887-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11095-016-1887-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26975360$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Seto, Yoshiki</creatorcontrib><creatorcontrib>Suzuki, Gen</creatorcontrib><creatorcontrib>Leung, Sharon Shui Yee</creatorcontrib><creatorcontrib>Chan, Hak-Kim</creatorcontrib><creatorcontrib>Onoue, Satomi</creatorcontrib><title>Development of an Improved Inhalable Powder Formulation of Pirfenidone by Spray-Drying: In Vitro Characterization and Pharmacokinetic Profiling</title><title>Pharmaceutical research</title><addtitle>Pharm Res</addtitle><addtitle>Pharm Res</addtitle><description>Purpose
Previously, a respirable powder (RP) formulation of pirfenidone (PFD) was developed for reducing phototoxic risk; however, PFD-RP demonstrated unacceptable
in vitro
inhalation performance. The present study aimed to develop a new RP system of PFD with favorable inhalation properties by spray-drying method.
Methods
Spray-dried PFD (SD/PFD) was prepared by spray-drying with L-leucine, and the physicochemical properties and efficacy in an antigen-sensitized airway inflammation model were assessed. A pharmacokinetic study was also conducted after intratracheal and oral administration of PFD formulations.
Results
Regarding powder characterization, SD/PFD had dimpled surface with the mean diameter of 1.793 μm. In next generation impactor analysis, SD/PFD demonstrated high
in vitro
inhalation performance without the need of carrier particles, and the fine particle fraction of SD/PFD was calculated to be 62.4%. Insufflated SD/PFD (0.3 mg-PFD/rat) attenuated antigen-evoked inflammatory events in the lung, including infiltration of inflammatory cells and myeloperoxidase activity. Systemic exposure level of PFD after insufflation of SD/PFD at the pharmacologically effective dose was 600-fold lower than that after oral administration of PFD at the phototoxic dose.
Conclusion
SD/PFD would be suitable for inhalation, and the utilization of an RP system with SD/PFD would provide a safer medication compared with oral administration of PFD.</description><subject>Administration, Inhalation</subject><subject>Administration, Oral</subject><subject>Aerosols</subject><subject>Analysis</subject><subject>Animals</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - chemistry</subject><subject>Anti-Inflammatory Agents - pharmacokinetics</subject><subject>Anti-Inflammatory Agents - toxicity</subject><subject>Antigens</subject><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedical Engineering and Bioengineering</subject><subject>Biomedicine</subject><subject>Bronchoalveolar Lavage Fluid - immunology</subject><subject>Chromatography, Liquid</subject><subject>Desiccation</subject><subject>Disease Models, Animal</subject><subject>Drug Compounding</subject><subject>Inflammation</subject><subject>Kinetics</subject><subject>Male</subject><subject>Medical Law</subject><subject>Ovalbumin</subject><subject>Particle Size</subject><subject>Peroxidase - metabolism</subject><subject>Pharmacology</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Pneumonia - blood</subject><subject>Pneumonia - chemically induced</subject><subject>Pneumonia - immunology</subject><subject>Pneumonia - prevention & control</subject><subject>Powders</subject><subject>Pyridones - administration & dosage</subject><subject>Pyridones - chemistry</subject><subject>Pyridones - pharmacokinetics</subject><subject>Pyridones - toxicity</subject><subject>Rats, Sprague-Dawley</subject><subject>Research Paper</subject><subject>Respiratory therapy</subject><subject>Spectrometry, Mass, Electrospray Ionization</subject><subject>Technology, Pharmaceutical - methods</subject><subject>Thrombosis</subject><issn>0724-8741</issn><issn>1573-904X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1ks1u1DAUhS0EotPCA7BBltiwSbFjJ7bZVVMKI1ViJH7EznLim6lLYg92UjR9CV4ZRym_Anlhyfc7V-deH4SeUHJKCREvEqVEVQWhdUGlFAW7h1a0EqxQhH-6j1ZElLyQgtMjdJzSNSFEUsUfoqOyVqJiNVmhb-dwA33YD-BHHDpsPN4M-xhuwOKNvzK9aXrA2_DVQsQXIQ5Tb0YX_MxuXezAOxs84OaA3-2jORTn8eD87mUW449ujAGvr0w07QjR3S5K4y3e5sfBtOGz8zC6Fm9j6FyfhY_Qg870CR7f3Sfow8Wr9-s3xeXb15v12WXRcqbGoi0tbYwyJVWV7ECVNbfATC1BVFUJrK4FKGuoUABK2EbVtlKN4iBA8FJ27AQ9X_rmWb9MkEY9uNRC3xsPYUqaCinybhkvM_rsL_Q6TNFndzNVqUopzn5RO9ODdr4LYx57bqrPBBecSalopk7_QeVjYXBtXmTeAvwpoIugjSGlCJ3eRzeYeNCU6DkEegmBziHQcwj0bOXpneGpGcD-VPz49QyUC5Byye8g_jbRf7t-BwG3vPo</recordid><startdate>20160601</startdate><enddate>20160601</enddate><creator>Seto, Yoshiki</creator><creator>Suzuki, Gen</creator><creator>Leung, Sharon Shui Yee</creator><creator>Chan, Hak-Kim</creator><creator>Onoue, Satomi</creator><general>Springer US</general><general>Springer</general><general>Springer Nature B.V</general><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>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20160601</creationdate><title>Development of an Improved Inhalable Powder Formulation of Pirfenidone by Spray-Drying: In Vitro Characterization and Pharmacokinetic Profiling</title><author>Seto, Yoshiki ; Suzuki, Gen ; Leung, Sharon Shui Yee ; Chan, Hak-Kim ; Onoue, Satomi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c439t-c2d1ba9a21958fe9264de3a68e7552e3667e9da179ee97db96d59b94e7e7428f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administration, Inhalation</topic><topic>Administration, Oral</topic><topic>Aerosols</topic><topic>Analysis</topic><topic>Animals</topic><topic>Anti-Inflammatory Agents - administration & dosage</topic><topic>Anti-Inflammatory Agents - chemistry</topic><topic>Anti-Inflammatory Agents - pharmacokinetics</topic><topic>Anti-Inflammatory Agents - toxicity</topic><topic>Antigens</topic><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedical Engineering and Bioengineering</topic><topic>Biomedicine</topic><topic>Bronchoalveolar Lavage Fluid - immunology</topic><topic>Chromatography, Liquid</topic><topic>Desiccation</topic><topic>Disease Models, Animal</topic><topic>Drug Compounding</topic><topic>Inflammation</topic><topic>Kinetics</topic><topic>Male</topic><topic>Medical Law</topic><topic>Ovalbumin</topic><topic>Particle Size</topic><topic>Peroxidase - metabolism</topic><topic>Pharmacology</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Pneumonia - blood</topic><topic>Pneumonia - chemically induced</topic><topic>Pneumonia - immunology</topic><topic>Pneumonia - prevention & control</topic><topic>Powders</topic><topic>Pyridones - administration & dosage</topic><topic>Pyridones - chemistry</topic><topic>Pyridones - pharmacokinetics</topic><topic>Pyridones - toxicity</topic><topic>Rats, Sprague-Dawley</topic><topic>Research Paper</topic><topic>Respiratory therapy</topic><topic>Spectrometry, Mass, Electrospray Ionization</topic><topic>Technology, Pharmaceutical - methods</topic><topic>Thrombosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Seto, Yoshiki</creatorcontrib><creatorcontrib>Suzuki, Gen</creatorcontrib><creatorcontrib>Leung, Sharon Shui Yee</creatorcontrib><creatorcontrib>Chan, Hak-Kim</creatorcontrib><creatorcontrib>Onoue, Satomi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmaceutical research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Seto, Yoshiki</au><au>Suzuki, Gen</au><au>Leung, Sharon Shui Yee</au><au>Chan, Hak-Kim</au><au>Onoue, Satomi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development of an Improved Inhalable Powder Formulation of Pirfenidone by Spray-Drying: In Vitro Characterization and Pharmacokinetic Profiling</atitle><jtitle>Pharmaceutical research</jtitle><stitle>Pharm Res</stitle><addtitle>Pharm Res</addtitle><date>2016-06-01</date><risdate>2016</risdate><volume>33</volume><issue>6</issue><spage>1447</spage><epage>1455</epage><pages>1447-1455</pages><issn>0724-8741</issn><eissn>1573-904X</eissn><abstract>Purpose
Previously, a respirable powder (RP) formulation of pirfenidone (PFD) was developed for reducing phototoxic risk; however, PFD-RP demonstrated unacceptable
in vitro
inhalation performance. The present study aimed to develop a new RP system of PFD with favorable inhalation properties by spray-drying method.
Methods
Spray-dried PFD (SD/PFD) was prepared by spray-drying with L-leucine, and the physicochemical properties and efficacy in an antigen-sensitized airway inflammation model were assessed. A pharmacokinetic study was also conducted after intratracheal and oral administration of PFD formulations.
Results
Regarding powder characterization, SD/PFD had dimpled surface with the mean diameter of 1.793 μm. In next generation impactor analysis, SD/PFD demonstrated high
in vitro
inhalation performance without the need of carrier particles, and the fine particle fraction of SD/PFD was calculated to be 62.4%. Insufflated SD/PFD (0.3 mg-PFD/rat) attenuated antigen-evoked inflammatory events in the lung, including infiltration of inflammatory cells and myeloperoxidase activity. Systemic exposure level of PFD after insufflation of SD/PFD at the pharmacologically effective dose was 600-fold lower than that after oral administration of PFD at the phototoxic dose.
Conclusion
SD/PFD would be suitable for inhalation, and the utilization of an RP system with SD/PFD would provide a safer medication compared with oral administration of PFD.</abstract><cop>New York</cop><pub>Springer US</pub><pmid>26975360</pmid><doi>10.1007/s11095-016-1887-3</doi><tpages>9</tpages></addata></record> |
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| subjects | Administration, Inhalation Administration, Oral Aerosols Analysis Animals Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - chemistry Anti-Inflammatory Agents - pharmacokinetics Anti-Inflammatory Agents - toxicity Antigens Biochemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Bronchoalveolar Lavage Fluid - immunology Chromatography, Liquid Desiccation Disease Models, Animal Drug Compounding Inflammation Kinetics Male Medical Law Ovalbumin Particle Size Peroxidase - metabolism Pharmacology Pharmacology/Toxicology Pharmacy Pneumonia - blood Pneumonia - chemically induced Pneumonia - immunology Pneumonia - prevention & control Powders Pyridones - administration & dosage Pyridones - chemistry Pyridones - pharmacokinetics Pyridones - toxicity Rats, Sprague-Dawley Research Paper Respiratory therapy Spectrometry, Mass, Electrospray Ionization Technology, Pharmaceutical - methods Thrombosis |
| title | Development of an Improved Inhalable Powder Formulation of Pirfenidone by Spray-Drying: In Vitro Characterization and Pharmacokinetic Profiling |
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