Preclinical Experimental and Mathematical Approaches for Assessing Effective Doses of Inhaled Drugs, Using Mometasone to Support Human Dose Predictions
Understanding the relationship between dose, lung exposure, and drug efficacy continues to be a challenging aspect of inhaled drug development. An experimental inhalation platform was developed using mometasone furoate to link rodent lung exposure to its in vivo pharmacodynamic (PD) effects. We asse...
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| Veröffentlicht in: | Journal of aerosol medicine 2016-08, Vol.29 (4), p.362-377 |
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| creator | Caniga, Michael Cabal, Antonio Mehta, Khamir Ross, David S Gil, Malgorzata A Woodhouse, Janice D Eckman, Joseph Naber, John R Callahan, Marissa K Goncalves, Luciano Hill, Susan E Mcleod, Robbie L McIntosh, Fraser Freke, Mark C Visser, Sandra A G Johnson, Neil Salmon, Michael Cicmil, Milenko |
| description | Understanding the relationship between dose, lung exposure, and drug efficacy continues to be a challenging aspect of inhaled drug development. An experimental inhalation platform was developed using mometasone furoate to link rodent lung exposure to its in vivo pharmacodynamic (PD) effects.
We assessed the effect of mometasone delivered directly to the lung in two different rodent PD models of lung inflammation. The data obtained were used to develop and evaluate a mathematical model to estimate drug dissolution, transport, distribution, and efficacy, following inhaled delivery in rodents and humans.
Mometasone directly delivered to the lung, in both LPS and Alternaria alternata rat models, resulted in dose dependent inhibition of BALf cellular inflammation. The parameters for our mathematical model were calibrated to describe the observed lung and systemic exposure profiles of mometasone in humans and in animal models. We found that physicochemical properties, such as lung fluid solubility and lipophilicity, strongly influenced compound distribution and lung retention.
Presently, we report on a novel and sophisticated mathematical model leading to improvements in a current inhaled drug development practices by providing a quantitative understanding of the relationship between PD effects and drug concentration in lungs. |
| doi_str_mv | 10.1089/jamp.2015.1253 |
| format | Article |
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We assessed the effect of mometasone delivered directly to the lung in two different rodent PD models of lung inflammation. The data obtained were used to develop and evaluate a mathematical model to estimate drug dissolution, transport, distribution, and efficacy, following inhaled delivery in rodents and humans.
Mometasone directly delivered to the lung, in both LPS and Alternaria alternata rat models, resulted in dose dependent inhibition of BALf cellular inflammation. The parameters for our mathematical model were calibrated to describe the observed lung and systemic exposure profiles of mometasone in humans and in animal models. We found that physicochemical properties, such as lung fluid solubility and lipophilicity, strongly influenced compound distribution and lung retention.
Presently, we report on a novel and sophisticated mathematical model leading to improvements in a current inhaled drug development practices by providing a quantitative understanding of the relationship between PD effects and drug concentration in lungs.</description><identifier>ISSN: 1941-2711</identifier><identifier>EISSN: 1941-2703</identifier><identifier>DOI: 10.1089/jamp.2015.1253</identifier><identifier>PMID: 26859446</identifier><language>eng</language><publisher>United States: Mary Ann Liebert, Inc</publisher><subject>Administration, Inhalation ; Aerosols ; Alternaria ; Alternaria alternata ; Alternariosis - drug therapy ; Alternariosis - metabolism ; Alternariosis - microbiology ; Alternariosis - physiopathology ; Animals ; Anti-Inflammatory Agents - administration & dosage ; Anti-Inflammatory Agents - pharmacokinetics ; Disease Models, Animal ; Drug Dosage Calculations ; Health technology assessment ; Humans ; Lipopolysaccharides ; Lung - drug effects ; Lung - metabolism ; Lung - physiopathology ; Lung Diseases, Fungal - drug therapy ; Lung Diseases, Fungal - metabolism ; Lung Diseases, Fungal - microbiology ; Lung Diseases, Fungal - physiopathology ; Male ; Models, Biological ; Mometasone Furoate - administration & dosage ; Mometasone Furoate - pharmacokinetics ; Pneumonia - chemically induced ; Pneumonia - drug therapy ; Pneumonia - metabolism ; Pneumonia - physiopathology ; Rats, Inbred BN ; Rats, Sprague-Dawley ; Species Specificity ; Tissue Distribution</subject><ispartof>Journal of aerosol medicine, 2016-08, Vol.29 (4), p.362-377</ispartof><rights>(©) Copyright 2016, Mary Ann Liebert, Inc.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c422t-9d5b04044ff9068b25cace088c37bdba8dc4b67ab2c4b8971090804ec8f9fdb33</citedby><cites>FETCH-LOGICAL-c422t-9d5b04044ff9068b25cace088c37bdba8dc4b67ab2c4b8971090804ec8f9fdb33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26859446$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Caniga, Michael</creatorcontrib><creatorcontrib>Cabal, Antonio</creatorcontrib><creatorcontrib>Mehta, Khamir</creatorcontrib><creatorcontrib>Ross, David S</creatorcontrib><creatorcontrib>Gil, Malgorzata A</creatorcontrib><creatorcontrib>Woodhouse, Janice D</creatorcontrib><creatorcontrib>Eckman, Joseph</creatorcontrib><creatorcontrib>Naber, John R</creatorcontrib><creatorcontrib>Callahan, Marissa K</creatorcontrib><creatorcontrib>Goncalves, Luciano</creatorcontrib><creatorcontrib>Hill, Susan E</creatorcontrib><creatorcontrib>Mcleod, Robbie L</creatorcontrib><creatorcontrib>McIntosh, Fraser</creatorcontrib><creatorcontrib>Freke, Mark C</creatorcontrib><creatorcontrib>Visser, Sandra A G</creatorcontrib><creatorcontrib>Johnson, Neil</creatorcontrib><creatorcontrib>Salmon, Michael</creatorcontrib><creatorcontrib>Cicmil, Milenko</creatorcontrib><title>Preclinical Experimental and Mathematical Approaches for Assessing Effective Doses of Inhaled Drugs, Using Mometasone to Support Human Dose Predictions</title><title>Journal of aerosol medicine</title><addtitle>J Aerosol Med Pulm Drug Deliv</addtitle><description>Understanding the relationship between dose, lung exposure, and drug efficacy continues to be a challenging aspect of inhaled drug development. An experimental inhalation platform was developed using mometasone furoate to link rodent lung exposure to its in vivo pharmacodynamic (PD) effects.
We assessed the effect of mometasone delivered directly to the lung in two different rodent PD models of lung inflammation. The data obtained were used to develop and evaluate a mathematical model to estimate drug dissolution, transport, distribution, and efficacy, following inhaled delivery in rodents and humans.
Mometasone directly delivered to the lung, in both LPS and Alternaria alternata rat models, resulted in dose dependent inhibition of BALf cellular inflammation. The parameters for our mathematical model were calibrated to describe the observed lung and systemic exposure profiles of mometasone in humans and in animal models. We found that physicochemical properties, such as lung fluid solubility and lipophilicity, strongly influenced compound distribution and lung retention.
Presently, we report on a novel and sophisticated mathematical model leading to improvements in a current inhaled drug development practices by providing a quantitative understanding of the relationship between PD effects and drug concentration in lungs.</description><subject>Administration, Inhalation</subject><subject>Aerosols</subject><subject>Alternaria</subject><subject>Alternaria alternata</subject><subject>Alternariosis - drug therapy</subject><subject>Alternariosis - metabolism</subject><subject>Alternariosis - microbiology</subject><subject>Alternariosis - physiopathology</subject><subject>Animals</subject><subject>Anti-Inflammatory Agents - administration & dosage</subject><subject>Anti-Inflammatory Agents - pharmacokinetics</subject><subject>Disease Models, Animal</subject><subject>Drug Dosage Calculations</subject><subject>Health technology assessment</subject><subject>Humans</subject><subject>Lipopolysaccharides</subject><subject>Lung - drug effects</subject><subject>Lung - metabolism</subject><subject>Lung - physiopathology</subject><subject>Lung Diseases, Fungal - drug therapy</subject><subject>Lung Diseases, Fungal - metabolism</subject><subject>Lung Diseases, Fungal - microbiology</subject><subject>Lung Diseases, Fungal - physiopathology</subject><subject>Male</subject><subject>Models, Biological</subject><subject>Mometasone Furoate - administration & dosage</subject><subject>Mometasone Furoate - pharmacokinetics</subject><subject>Pneumonia - chemically induced</subject><subject>Pneumonia - drug therapy</subject><subject>Pneumonia - metabolism</subject><subject>Pneumonia - physiopathology</subject><subject>Rats, Inbred BN</subject><subject>Rats, Sprague-Dawley</subject><subject>Species Specificity</subject><subject>Tissue Distribution</subject><issn>1941-2711</issn><issn>1941-2703</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkU1v1DAQhi0EoqVw5YgsceHALmPHcezjql1opVYgQc-R44y7WSV2sB0Ev4S_i3dbeuDEafzxzCuPH0JeM1gzUPrD3kzzmgOr14zX1RNyyrRgK95A9fRxzdgJeZHSHkAyIavn5IRLVWsh5Cn5_SWiHQc_WDPS7c8Z4zChz2VjfE9vTN7hZPLxdjPPMRi7w0RdiHSTEqY0-Du6dQ5tHn4gvQjljAZHr_zOjNjTi7jcpff09sjdhAmzScEjzYF-XeY5xEwvl8n4Yyctb-mHkhR8ekmeOTMmfPVQz8jtx-2388vV9edPV-eb65UVnOeV7usOBAjhnAapOl5bYxGUslXT9Z1RvRWdbEzHS1W6YaBBgUCrnHZ9V1Vn5N19bpnt-4Ipt9OQLI6j8RiW1DLFG6UagPo_UJBSgK51Qd_-g-7DEn0Z5EgxLhouC7W-p2wMKUV07Vx-38RfLYP2YLc92G0PdtuD3dLw5iF26SbsH_G_Oqs_ZY-iRw</recordid><startdate>201608</startdate><enddate>201608</enddate><creator>Caniga, Michael</creator><creator>Cabal, Antonio</creator><creator>Mehta, Khamir</creator><creator>Ross, David S</creator><creator>Gil, Malgorzata A</creator><creator>Woodhouse, Janice D</creator><creator>Eckman, Joseph</creator><creator>Naber, John R</creator><creator>Callahan, Marissa K</creator><creator>Goncalves, Luciano</creator><creator>Hill, Susan E</creator><creator>Mcleod, Robbie L</creator><creator>McIntosh, Fraser</creator><creator>Freke, Mark C</creator><creator>Visser, Sandra A G</creator><creator>Johnson, Neil</creator><creator>Salmon, Michael</creator><creator>Cicmil, Milenko</creator><general>Mary Ann Liebert, Inc</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>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</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>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>7QO</scope><scope>8FD</scope><scope>FR3</scope><scope>P64</scope></search><sort><creationdate>201608</creationdate><title>Preclinical Experimental and Mathematical Approaches for Assessing Effective Doses of Inhaled Drugs, Using Mometasone to Support Human Dose Predictions</title><author>Caniga, Michael ; Cabal, Antonio ; Mehta, Khamir ; Ross, David S ; Gil, Malgorzata A ; Woodhouse, Janice D ; Eckman, Joseph ; Naber, John R ; Callahan, Marissa K ; Goncalves, Luciano ; Hill, Susan E ; Mcleod, Robbie L ; McIntosh, Fraser ; Freke, Mark C ; Visser, Sandra A G ; Johnson, Neil ; Salmon, Michael ; Cicmil, Milenko</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c422t-9d5b04044ff9068b25cace088c37bdba8dc4b67ab2c4b8971090804ec8f9fdb33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administration, Inhalation</topic><topic>Aerosols</topic><topic>Alternaria</topic><topic>Alternaria alternata</topic><topic>Alternariosis - 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drug therapy</topic><topic>Pneumonia - metabolism</topic><topic>Pneumonia - physiopathology</topic><topic>Rats, Inbred BN</topic><topic>Rats, Sprague-Dawley</topic><topic>Species Specificity</topic><topic>Tissue Distribution</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Caniga, Michael</creatorcontrib><creatorcontrib>Cabal, Antonio</creatorcontrib><creatorcontrib>Mehta, Khamir</creatorcontrib><creatorcontrib>Ross, David S</creatorcontrib><creatorcontrib>Gil, Malgorzata A</creatorcontrib><creatorcontrib>Woodhouse, Janice D</creatorcontrib><creatorcontrib>Eckman, Joseph</creatorcontrib><creatorcontrib>Naber, John R</creatorcontrib><creatorcontrib>Callahan, Marissa K</creatorcontrib><creatorcontrib>Goncalves, Luciano</creatorcontrib><creatorcontrib>Hill, Susan E</creatorcontrib><creatorcontrib>Mcleod, Robbie L</creatorcontrib><creatorcontrib>McIntosh, Fraser</creatorcontrib><creatorcontrib>Freke, Mark C</creatorcontrib><creatorcontrib>Visser, Sandra A G</creatorcontrib><creatorcontrib>Johnson, Neil</creatorcontrib><creatorcontrib>Salmon, Michael</creatorcontrib><creatorcontrib>Cicmil, Milenko</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>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</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)</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>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</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><collection>Biotechnology Research Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><jtitle>Journal of aerosol medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Caniga, Michael</au><au>Cabal, Antonio</au><au>Mehta, Khamir</au><au>Ross, David S</au><au>Gil, Malgorzata A</au><au>Woodhouse, Janice D</au><au>Eckman, Joseph</au><au>Naber, John R</au><au>Callahan, Marissa K</au><au>Goncalves, Luciano</au><au>Hill, Susan E</au><au>Mcleod, Robbie L</au><au>McIntosh, Fraser</au><au>Freke, Mark C</au><au>Visser, Sandra A G</au><au>Johnson, Neil</au><au>Salmon, Michael</au><au>Cicmil, Milenko</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Preclinical Experimental and Mathematical Approaches for Assessing Effective Doses of Inhaled Drugs, Using Mometasone to Support Human Dose Predictions</atitle><jtitle>Journal of aerosol medicine</jtitle><addtitle>J Aerosol Med Pulm Drug Deliv</addtitle><date>2016-08</date><risdate>2016</risdate><volume>29</volume><issue>4</issue><spage>362</spage><epage>377</epage><pages>362-377</pages><issn>1941-2711</issn><eissn>1941-2703</eissn><abstract>Understanding the relationship between dose, lung exposure, and drug efficacy continues to be a challenging aspect of inhaled drug development. An experimental inhalation platform was developed using mometasone furoate to link rodent lung exposure to its in vivo pharmacodynamic (PD) effects.
We assessed the effect of mometasone delivered directly to the lung in two different rodent PD models of lung inflammation. The data obtained were used to develop and evaluate a mathematical model to estimate drug dissolution, transport, distribution, and efficacy, following inhaled delivery in rodents and humans.
Mometasone directly delivered to the lung, in both LPS and Alternaria alternata rat models, resulted in dose dependent inhibition of BALf cellular inflammation. The parameters for our mathematical model were calibrated to describe the observed lung and systemic exposure profiles of mometasone in humans and in animal models. We found that physicochemical properties, such as lung fluid solubility and lipophilicity, strongly influenced compound distribution and lung retention.
Presently, we report on a novel and sophisticated mathematical model leading to improvements in a current inhaled drug development practices by providing a quantitative understanding of the relationship between PD effects and drug concentration in lungs.</abstract><cop>United States</cop><pub>Mary Ann Liebert, Inc</pub><pmid>26859446</pmid><doi>10.1089/jamp.2015.1253</doi><tpages>16</tpages></addata></record> |
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| ispartof | Journal of aerosol medicine, 2016-08, Vol.29 (4), p.362-377 |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | Administration, Inhalation Aerosols Alternaria Alternaria alternata Alternariosis - drug therapy Alternariosis - metabolism Alternariosis - microbiology Alternariosis - physiopathology Animals Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - pharmacokinetics Disease Models, Animal Drug Dosage Calculations Health technology assessment Humans Lipopolysaccharides Lung - drug effects Lung - metabolism Lung - physiopathology Lung Diseases, Fungal - drug therapy Lung Diseases, Fungal - metabolism Lung Diseases, Fungal - microbiology Lung Diseases, Fungal - physiopathology Male Models, Biological Mometasone Furoate - administration & dosage Mometasone Furoate - pharmacokinetics Pneumonia - chemically induced Pneumonia - drug therapy Pneumonia - metabolism Pneumonia - physiopathology Rats, Inbred BN Rats, Sprague-Dawley Species Specificity Tissue Distribution |
| title | Preclinical Experimental and Mathematical Approaches for Assessing Effective Doses of Inhaled Drugs, Using Mometasone to Support Human Dose Predictions |
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