Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model
- Autores
- Errecalde, Jorge Oscar; Lifschitz, Adrian Luis; Vecchioli, Graciela Isabel; Ceballos, Laura; Errecalde, Francisco; Ballent, Mariana; Marín, Gustavo Horacio; Daniele, Martín Rafael; Turic, Esteban; Spitzer, Eduardo; Toneguzzo, Fernando; Gold, Silvia; Krolewiecki, Alejandro J.; Alvarez, Luis; Lanusse, Carlos Edmundo
- Año de publicación
- 2021
- Idioma
- inglés
- Tipo de recurso
- artículo
- Estado
- versión publicada
- Descripción
- Recently published data indicates that high ivermectin (IVM) concentrations suppress in vitro SARS-CoV-2 replication. Nasal IVM spray administration may contribute to attaining high drug concentrations in nasopharyngeal tissue, a primary site of virus entrance/replication. The safety and pharmacokinetic performances of a novel IVM spray formulation were assessed in a pig model. Piglets received IVM either orally (0.2 mg/kg) or by one or two nasal spray doses. The overall safety, and histopathology of the IVM-spray application site tissues, were assessed. The IVM concentration profiles measured in plasma and respiratory tract tissues after the nasal spray were compared with those achieved after the oral administration. Animals tolerated well the nasal spray formulation. No local/systemic adverse events were observed. After nasal administration, the highest IVM concentrations were measured in nasopharyngeal and lung tissues. The nasal/oral IVM concentration ratios in nasopharyngeal and lung tissues markedly increased by repeating (12 h apart) the spray application. The fast attainment of high and persistent IVM concentrations in nasopharyngeal tissue is the main advantage of the nasal over the oral route. These original results support the undertaking of future clinical trials to evaluate the safety/efficacy of the nasal IVM spray application in the prevention and/or treatment of COVID-19.
Facultad de Ciencias Médicas
Facultad de Ciencias Veterinarias - Materia
-
Medicina
Biología
Ivermectin
Covid 19
Nasal-spray formulation - Nivel de accesibilidad
- acceso abierto
- Condiciones de uso
- http://creativecommons.org/licenses/by-nc-nd/4.0/
- Repositorio
.jpg)
- Institución
- Universidad Nacional de La Plata
- OAI Identificador
- oai:sedici.unlp.edu.ar:10915/134952
Ver los metadatos del registro completo
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Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig ModelErrecalde, Jorge OscarLifschitz, Adrian LuisVecchioli, Graciela IsabelCeballos, LauraErrecalde, FranciscoBallent, MarianaMarín, Gustavo HoracioDaniele, Martín RafaelTuric, EstebanSpitzer, EduardoToneguzzo, FernandoGold, SilviaKrolewiecki, Alejandro J.Alvarez, LuisLanusse, Carlos EdmundoMedicinaBiologíaIvermectinCovid 19Nasal-spray formulationRecently published data indicates that high ivermectin (IVM) concentrations suppress <i>in vitro</i> SARS-CoV-2 replication. Nasal IVM spray administration may contribute to attaining high drug concentrations in nasopharyngeal tissue, a primary site of virus entrance/replication. The safety and pharmacokinetic performances of a novel IVM spray formulation were assessed in a pig model. Piglets received IVM either orally (0.2 mg/kg) or by one or two nasal spray doses. The overall safety, and histopathology of the IVM-spray application site tissues, were assessed. The IVM concentration profiles measured in plasma and respiratory tract tissues after the nasal spray were compared with those achieved after the oral administration. Animals tolerated well the nasal spray formulation. No local/systemic adverse events were observed. After nasal administration, the highest IVM concentrations were measured in nasopharyngeal and lung tissues. The nasal/oral IVM concentration ratios in nasopharyngeal and lung tissues markedly increased by repeating (12 h apart) the spray application. The fast attainment of high and persistent IVM concentrations in nasopharyngeal tissue is the main advantage of the nasal over the oral route. These original results support the undertaking of future clinical trials to evaluate the safety/efficacy of the nasal IVM spray application in the prevention and/or treatment of COVID-19.Facultad de Ciencias MédicasFacultad de Ciencias Veterinarias2021-06info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArticulohttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdf2501-2507http://sedici.unlp.edu.ar/handle/10915/134952enginfo:eu-repo/semantics/altIdentifier/issn/1520-6017info:eu-repo/semantics/altIdentifier/issn/0022-3549info:eu-repo/semantics/altIdentifier/doi/10.1016/j.xphs.2021.01.017info:eu-repo/semantics/altIdentifier/pmid/33493479info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)reponame:SEDICI (UNLP)instname:Universidad Nacional de La Platainstacron:UNLP2025-10-22T17:13:21Zoai:sedici.unlp.edu.ar:10915/134952Institucionalhttp://sedici.unlp.edu.ar/Universidad públicaNo correspondehttp://sedici.unlp.edu.ar/oai/snrdalira@sedici.unlp.edu.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:13292025-10-22 17:13:21.382SEDICI (UNLP) - Universidad Nacional de La Platafalse |
| dc.title.none.fl_str_mv |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model |
| title |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model |
| spellingShingle |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model Errecalde, Jorge Oscar Medicina Biología Ivermectin Covid 19 Nasal-spray formulation |
| title_short |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model |
| title_full |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model |
| title_fullStr |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model |
| title_full_unstemmed |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model |
| title_sort |
Safety and Pharmacokinetic Assessments of a Novel Ivermectin Nasal Spray Formulation in a Pig Model |
| dc.creator.none.fl_str_mv |
Errecalde, Jorge Oscar Lifschitz, Adrian Luis Vecchioli, Graciela Isabel Ceballos, Laura Errecalde, Francisco Ballent, Mariana Marín, Gustavo Horacio Daniele, Martín Rafael Turic, Esteban Spitzer, Eduardo Toneguzzo, Fernando Gold, Silvia Krolewiecki, Alejandro J. Alvarez, Luis Lanusse, Carlos Edmundo |
| author |
Errecalde, Jorge Oscar |
| author_facet |
Errecalde, Jorge Oscar Lifschitz, Adrian Luis Vecchioli, Graciela Isabel Ceballos, Laura Errecalde, Francisco Ballent, Mariana Marín, Gustavo Horacio Daniele, Martín Rafael Turic, Esteban Spitzer, Eduardo Toneguzzo, Fernando Gold, Silvia Krolewiecki, Alejandro J. Alvarez, Luis Lanusse, Carlos Edmundo |
| author_role |
author |
| author2 |
Lifschitz, Adrian Luis Vecchioli, Graciela Isabel Ceballos, Laura Errecalde, Francisco Ballent, Mariana Marín, Gustavo Horacio Daniele, Martín Rafael Turic, Esteban Spitzer, Eduardo Toneguzzo, Fernando Gold, Silvia Krolewiecki, Alejandro J. Alvarez, Luis Lanusse, Carlos Edmundo |
| author2_role |
author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Medicina Biología Ivermectin Covid 19 Nasal-spray formulation |
| topic |
Medicina Biología Ivermectin Covid 19 Nasal-spray formulation |
| dc.description.none.fl_txt_mv |
Recently published data indicates that high ivermectin (IVM) concentrations suppress <i>in vitro</i> SARS-CoV-2 replication. Nasal IVM spray administration may contribute to attaining high drug concentrations in nasopharyngeal tissue, a primary site of virus entrance/replication. The safety and pharmacokinetic performances of a novel IVM spray formulation were assessed in a pig model. Piglets received IVM either orally (0.2 mg/kg) or by one or two nasal spray doses. The overall safety, and histopathology of the IVM-spray application site tissues, were assessed. The IVM concentration profiles measured in plasma and respiratory tract tissues after the nasal spray were compared with those achieved after the oral administration. Animals tolerated well the nasal spray formulation. No local/systemic adverse events were observed. After nasal administration, the highest IVM concentrations were measured in nasopharyngeal and lung tissues. The nasal/oral IVM concentration ratios in nasopharyngeal and lung tissues markedly increased by repeating (12 h apart) the spray application. The fast attainment of high and persistent IVM concentrations in nasopharyngeal tissue is the main advantage of the nasal over the oral route. These original results support the undertaking of future clinical trials to evaluate the safety/efficacy of the nasal IVM spray application in the prevention and/or treatment of COVID-19. Facultad de Ciencias Médicas Facultad de Ciencias Veterinarias |
| description |
Recently published data indicates that high ivermectin (IVM) concentrations suppress <i>in vitro</i> SARS-CoV-2 replication. Nasal IVM spray administration may contribute to attaining high drug concentrations in nasopharyngeal tissue, a primary site of virus entrance/replication. The safety and pharmacokinetic performances of a novel IVM spray formulation were assessed in a pig model. Piglets received IVM either orally (0.2 mg/kg) or by one or two nasal spray doses. The overall safety, and histopathology of the IVM-spray application site tissues, were assessed. The IVM concentration profiles measured in plasma and respiratory tract tissues after the nasal spray were compared with those achieved after the oral administration. Animals tolerated well the nasal spray formulation. No local/systemic adverse events were observed. After nasal administration, the highest IVM concentrations were measured in nasopharyngeal and lung tissues. The nasal/oral IVM concentration ratios in nasopharyngeal and lung tissues markedly increased by repeating (12 h apart) the spray application. The fast attainment of high and persistent IVM concentrations in nasopharyngeal tissue is the main advantage of the nasal over the oral route. These original results support the undertaking of future clinical trials to evaluate the safety/efficacy of the nasal IVM spray application in the prevention and/or treatment of COVID-19. |
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2021 |
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2021-06 |
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eng |
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