{"id":{"repo_id":"vcu","oai_identifier":"oai:scholarscompass.vcu.edu:etd-1278"},"canonical_url":"https://search.dev.ndltd.org/etd/vcu/oai:scholarscompass.vcu.edu:etd-1278","repository":{"repo_id":"vcu","name":"Virginia Commonwealth University","base_url":"https://scholarscompass.vcu.edu/do/oai/"},"display":{"title":"DEVELOPMENT OF A NOVEL APPROACH TO ASSESS QUALITATIVE AND QUANTITATIVE DYNAMICS ASSOCIATED WITH THE SUBCUTANEOUS OR INTRAMUSCULAR ADMINISTRATION OF PHARMACEUTICALS AND ASSOCIATED PARENTERAL DELIVERY SYSTEMS","abstract":"There has been a significant increase in the number of injectable pharmaceutical products over the last decade that have been incorporated into unique delivery systems such as pen injectors, auto-injectors, or pre-filled syringes. The advancement of these delivery systems and the paradigm shift towards administration of injectables in the out-of-hospital or home setting have introduced variables that can affect the bioavailability of injectable drugs and potential pharmacologic outcomes. An approach that allows for the qualitative and quantitative dispersion assessment of an injectable at the moment of tissue deposition coupled with an assessment of systemic exposure parameters could provide substantial information to researchers developing new injectable formulations and associated delivery systems. The overall goal of this research project was to develop an approach for investigating various injection dynamics, more specifically, dispersion dynamics associated with the administration of parenteral pharmaceutical products utilizing delivery technologies designed to deliver drug below the dermis. This was accomplished by first evaluating the safety and usability of computed tomography (CT) scanning as a novel radioimaging approach to assess qualitative and quantitative dispersion parameters in a cadaver study followed by a randomized, controlled, clinical study to assess CT tissue dispersion and the systemic exposure of iohexol, administered subcutaneously by two delivery systems in human volunteers. The primary finding of this work was the demonstration that CT scanning may be combined with a systemic exposure assessment to provide an effective paradigm for investigating dynamics of injectable delivery impacted by a variety of factors, including the choice of delivery system. In this study, iohexol delivered subcutaneously by an auto-injector resulted in notable qualitative and quantitative dispersion differences, including a higher rate of iohexol loss from the extravascular tissue, as well as differences in early plasma exposure as compared to a pre-filled syringe delivery system. The injections and CT scanning were well tolerated with adverse events limited to mild injection site reactions resolving without intervention. This research resulted in a novel local in-vivo(extravascular disappearance), systemic in-vivo(intravascular appearance) correlation approach that could be utilized to assess a wide variety of dynamics associated with injectable drug delivery below the dermis.","abstract_html":"There has been a significant increase in the number of injectable pharmaceutical products over the last decade that have been incorporated into unique delivery systems such as pen injectors, auto-injectors, or pre-filled syringes. The advancement of these delivery systems and the paradigm shift towards administration of injectables in the out-of-hospital or home setting have introduced variables that can affect the bioavailability of injectable drugs and potential pharmacologic outcomes. An approach that allows for the qualitative and quantitative dispersion assessment of an injectable at the moment of tissue deposition coupled with an assessment of systemic exposure parameters could provide substantial information to researchers developing new injectable formulations and associated delivery systems. The overall goal of this research project was to develop an approach for investigating various injection dynamics, more specifically, dispersion dynamics associated with the administration of parenteral pharmaceutical products utilizing delivery technologies designed to deliver drug below the dermis. This was accomplished by first evaluating the safety and usability of computed tomography (CT) scanning as a novel radioimaging approach to assess qualitative and quantitative dispersion parameters in a cadaver study followed by a randomized, controlled, clinical study to assess CT tissue dispersion and the systemic exposure of iohexol, administered subcutaneously by two delivery systems in human volunteers. The primary finding of this work was the demonstration that CT scanning may be combined with a systemic exposure assessment to provide an effective paradigm for investigating dynamics of injectable delivery impacted by a variety of factors, including the choice of delivery system. In this study, iohexol delivered subcutaneously by an auto-injector resulted in notable qualitative and quantitative dispersion differences, including a higher rate of iohexol loss from the extravascular tissue, as well as differences in early plasma exposure as compared to a pre-filled syringe delivery system. The injections and CT scanning were well tolerated with adverse events limited to mild injection site reactions resolving without intervention. This research resulted in a novel local in-vivo(extravascular disappearance), systemic in-vivo(intravascular appearance) correlation approach that could be utilized to assess a wide variety of dynamics associated with injectable drug delivery below the dermis.","abstract_has_math":false,"creators":["Edwards, Eric"],"institution":null,"degree_name":"Doctor of Philosophy","degree_level":"Dissertation","degree_discipline":"Pharmaceutical Sciences","degree_department":null,"school":null,"contributors":["William Garnett","William Barr","Patricia Slattum","Robert Diegelmann","Jurgen Venitz"],"advisors":[],"committee_chairs":[],"committee_members":[],"year":2011,"date_issued":"2011-12-08T08:00:00Z","date_published":"2011-12-08T08:00:00Z","updated_at":"2026-07-24T05:53:41Z","subjects":["injectable drug delivery","parenteral drug delivery","injectable dispersion","injectable tissue dispersion","in-vivo injection models","injectable tissue deposition","parenteral delivery systems","Medicine and Health Sciences","Pharmacy and Pharmaceutical Sciences"],"languages":[],"rights":["© The Author"],"rights_urls":[],"identifier_entries":[{"key":"dc:identifier","label":"Identifier","values":["https://scholarscompass.vcu.edu/etd/279"],"render_values":[{"text":"https://scholarscompass.vcu.edu/etd/279","href":"https://scholarscompass.vcu.edu/etd/279","code":true}]}]},"links":{"outbound_url":"https://doi.org/10.25772/TZHQ-TA85","outbound_label":"DOI","outbound_source":"dc:identifier"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["William Garnett","William Barr","Patricia Slattum","Robert Diegelmann","Jurgen Venitz"]},{"key":"dc:creator","label":"Author","values":["Edwards, Eric"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:date.available","label":"Dc Date Available","values":["2016-12-13T08:00:00Z"]},{"key":"thesis:degree_discipline","label":"Discipline","values":["Pharmaceutical Sciences"]},{"key":"thesis:degree_level","label":"Degree Level","values":["Dissertation"]},{"key":"thesis:degree_name","label":"Degree Name","values":["Doctor of Philosophy"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["injectable drug delivery","parenteral drug delivery","injectable dispersion","injectable tissue dispersion","in-vivo injection models","injectable tissue deposition","parenteral delivery systems","Medicine and Health Sciences","Pharmacy and Pharmaceutical Sciences"]}]},{"id":"language_rights","label":"Language and Rights","entries":[{"key":"dc:rights","label":"Dc Rights","values":["© The Author"]}]},{"id":"identifiers","label":"Identifiers","entries":[{"key":"dc:identifier","label":"Identifier","values":["https://doi.org/10.25772/TZHQ-TA85","https://scholarscompass.vcu.edu/etd/279"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["There has been a significant increase in the number of injectable pharmaceutical products over the last decade that have been incorporated into unique delivery systems such as pen injectors, auto-injectors, or pre-filled syringes. The advancement of these delivery systems and the paradigm shift towards administration of injectables in the out-of-hospital or home setting have introduced variables that can affect the bioavailability of injectable drugs and potential pharmacologic outcomes. An approach that allows for the qualitative and quantitative dispersion assessment of an injectable at the moment of tissue deposition coupled with an assessment of systemic exposure parameters could provide substantial information to researchers developing new injectable formulations and associated delivery systems. The overall goal of this research project was to develop an approach for investigating various injection dynamics, more specifically, dispersion dynamics associated with the administration of parenteral pharmaceutical products utilizing delivery technologies designed to deliver drug below the dermis. This was accomplished by first evaluating the safety and usability of computed tomography (CT) scanning as a novel radioimaging approach to assess qualitative and quantitative dispersion parameters in a cadaver study followed by a randomized, controlled, clinical study to assess CT tissue dispersion and the systemic exposure of iohexol, administered subcutaneously by two delivery systems in human volunteers. The primary finding of this work was the demonstration that CT scanning may be combined with a systemic exposure assessment to provide an effective paradigm for investigating dynamics of injectable delivery impacted by a variety of factors, including the choice of delivery system. In this study, iohexol delivered subcutaneously by an auto-injector resulted in notable qualitative and quantitative dispersion differences, including a higher rate of iohexol loss from the extravascular tissue, as well as differences in early plasma exposure as compared to a pre-filled syringe delivery system. The injections and CT scanning were well tolerated with adverse events limited to mild injection site reactions resolving without intervention. This research resulted in a novel local in-vivo(extravascular disappearance), systemic in-vivo(intravascular appearance) correlation approach that could be utilized to assess a wide variety of dynamics associated with injectable drug delivery below the dermis."]},{"key":"dc:title","label":"Title","values":["DEVELOPMENT OF A NOVEL APPROACH TO ASSESS QUALITATIVE AND QUANTITATIVE DYNAMICS ASSOCIATED WITH THE SUBCUTANEOUS OR INTRAMUSCULAR ADMINISTRATION OF PHARMACEUTICALS AND ASSOCIATED PARENTERAL DELIVERY SYSTEMS"]}]}],"canonical_facts":{"dc:contributor":["William Garnett","William Barr","Patricia Slattum","Robert Diegelmann","Jurgen Venitz"],"dc:creator":["Edwards, Eric"],"dc:date.available":["2016-12-13T08:00:00Z"],"dc:description.abstract":["There has been a significant increase in the number of injectable pharmaceutical products over the last decade that have been incorporated into unique delivery systems such as pen injectors, auto-injectors, or pre-filled syringes. The advancement of these delivery systems and the paradigm shift towards administration of injectables in the out-of-hospital or home setting have introduced variables that can affect the bioavailability of injectable drugs and potential pharmacologic outcomes. An approach that allows for the qualitative and quantitative dispersion assessment of an injectable at the moment of tissue deposition coupled with an assessment of systemic exposure parameters could provide substantial information to researchers developing new injectable formulations and associated delivery systems. The overall goal of this research project was to develop an approach for investigating various injection dynamics, more specifically, dispersion dynamics associated with the administration of parenteral pharmaceutical products utilizing delivery technologies designed to deliver drug below the dermis. This was accomplished by first evaluating the safety and usability of computed tomography (CT) scanning as a novel radioimaging approach to assess qualitative and quantitative dispersion parameters in a cadaver study followed by a randomized, controlled, clinical study to assess CT tissue dispersion and the systemic exposure of iohexol, administered subcutaneously by two delivery systems in human volunteers. The primary finding of this work was the demonstration that CT scanning may be combined with a systemic exposure assessment to provide an effective paradigm for investigating dynamics of injectable delivery impacted by a variety of factors, including the choice of delivery system. In this study, iohexol delivered subcutaneously by an auto-injector resulted in notable qualitative and quantitative dispersion differences, including a higher rate of iohexol loss from the extravascular tissue, as well as differences in early plasma exposure as compared to a pre-filled syringe delivery system. The injections and CT scanning were well tolerated with adverse events limited to mild injection site reactions resolving without intervention. This research resulted in a novel local in-vivo(extravascular disappearance), systemic in-vivo(intravascular appearance) correlation approach that could be utilized to assess a wide variety of dynamics associated with injectable drug delivery below the dermis."],"dc:identifier":["https://doi.org/10.25772/TZHQ-TA85","https://scholarscompass.vcu.edu/etd/279"],"dc:rights":["© The Author"],"dc:subject":["injectable drug delivery","parenteral drug delivery","injectable dispersion","injectable tissue dispersion","in-vivo injection models","injectable tissue deposition","parenteral delivery systems","Medicine and Health Sciences","Pharmacy and Pharmaceutical Sciences"],"dc:title":["DEVELOPMENT OF A NOVEL APPROACH TO ASSESS QUALITATIVE AND QUANTITATIVE DYNAMICS ASSOCIATED WITH THE SUBCUTANEOUS OR INTRAMUSCULAR ADMINISTRATION OF PHARMACEUTICALS AND ASSOCIATED PARENTERAL DELIVERY SYSTEMS"],"thesis:degree_discipline":["Pharmaceutical Sciences"],"thesis:degree_level":["Dissertation"],"thesis:degree_name":["Doctor of Philosophy"]},"updated_at":"2026-07-24T05:53:41Z"}