Anatomically realistic nasal replicas capturing the range of nasal spray drug delivery in adults.

Administration, Intranasal Fluticasone Mometasone Furoate Nasal Sprays Nose Reproducibility of Results
Anatomical variability Bioequivalence In vitro aerosol testing Locally-acting drugs Nasal spray Regional deposition

Journal

International journal of pharmaceutics
ISSN: 1873-3476
Titre abrégé: Int J Pharm
Pays: Netherlands
ID NLM: 7804127

Informations de publication

Date de publication:
25 Jun 2022
Historique:
received: 09 03 2022
revised: 16 05 2022
accepted: 22 05 2022
pubmed: 2 6 2022
medline: 22 6 2022
entrez: 1 6 2022
Statut: ppublish

Résumé

To improve the relationships between commonly conducted in vitro studies for locally-acting nasal spray drug products with in vivo regional deposition, this study developed a set of in vitro adult nasal geometries that captured the range of nasal drug delivery to the region posterior to internal nasal valve (INV), also known as posterior delivery (PD), and evaluated their performance with existing in vivo data. The PD of fluticasone propionate (FP) and fluticasone furoate (FF) in 40 nasal cavities was statistically analyzed to identify three airway models representing the low, mean, and high PD in adults. The models were also externally validated by comparing the in vitro nasal deposition from a different drug product (mometasone furoate (MF)) with the relevant in vivo data. The three selected geometries represented the low, mean, and high PD with multiple nasal sprays. They were verified in terms of reproducibility of in vitro data and validated by showing a reasonable agreement with preexisting in vivo MF PD despite differences in administration and defining the regions. The three models are envisioned to potentially facilitate the development of locally-acting nasal sprays and provide a better understanding of how in vitro metrics relate to in vivo regional nasal deposition.

Identifiants

DOI: 10.1016/j.ijpharm.2022.121858 PMID: 35643344
pubmed: 35643344
pii: S0378-5173(22)00413-6
doi: 10.1016/j.ijpharm.2022.121858
pii:
doi:

Substances chimiques

Nasal Sprays 0
Mometasone Furoate 04201GDN4R
Fluticasone CUT2W21N7U

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

121858

Informations de copyright

Copyright © 2022 Elsevier B.V. All rights reserved.

Auteurs

Ali Alfaifi (A)

Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA.

Sana Hosseini (S)

Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA.

Amir R Esmaeili (AR)

Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA.

Ross Walenga (R)

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Andrew Babiskin (A)

Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Theodore Schuman (T)

Department of Otolaryngology - Head and Neck Surgery, VCU Health, Richmond, VA, USA.

Worth Longest (W)

Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA; Department of Pharmaceutics, Virginia Commonwealth University, Richmond, VA, USA.

Michael Hindle (M)

Department of Pharmaceutics, Virginia Commonwealth University, Richmond, VA, USA.

Laleh Golshahi (L)

Department of Mechanical and Nuclear Engineering, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: lgolshahi@vcu.edu.

Articles similaires

Relative victimization scale: initial development and retrospective reports of the impact on mental health.

Hacer Belen
1.00
Humans Male Crime Victims Female Bullying

Cultural adaptation and validation of the Sinhala version of the spiritual needs assessment for patients (S-SNAP) questionnaire.

Udayangani Ramadasa, Shehan Silva, Suraj Perera et al.
1.00
Humans Middle Aged Female Male Surveys and Questionnaires

Development of the two-factor modified Kids Eating Disorder Survey (M-KEDS): a validation study with hispanic adolescents.

Tabbetha D Lopez, Aliye B Cepni, Lenora P Goodman et al.
1.00
Adolescent Child Female Humans Male

Use of Artificial Intelligence in Cobb Angle Measurement for Scoliosis: Retrospective Reliability and Accuracy Study of a Mobile App.

Haodong Li, Chuang Qian, Weili Yan et al.
1.00
Humans Scoliosis Mobile Applications Retrospective Studies Artificial Intelligence

Classifications MeSH

questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Administration par voie topique › Administration par voie muqueuse › Administration par voie nasale › Anatomically realistic nasal replicas...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Androstanes › Androstènes › Androstadiènes › Fluticasone › Anatomically realistic nasal replicas...
questionsmedicales.fr › Composés polycycliques › Composés à cycles fusionnés › Stéroïdes › Prégnanes › Prégnadiènes › Prégnadiènediols › Furoate de mométasone › Anatomically realistic nasal replicas...
questionsmedicales.fr › Préparations pharmaceutiques › Colloïdes › Aérosols › Pulvérisations nasales › Anatomically realistic nasal replicas...
questionsmedicales.fr › Organes des sens › Nez › Anatomically realistic nasal replicas...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Reproductibilité des résultats › Anatomically realistic nasal replicas...