Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution for Formulations of Locally Acting Mometasone Furoate Suspension-Based Nasal Sprays-Reference-Cited by-同舟云学术

Sensitivity of Pharmacokinetics to Differences in the Particle Size Distribution for Formulations of Locally Acting Mometasone Furoate Suspension-Based Nasal Sprays

Published:2023-09-29 Issue:11 Volume:20 Page:5690-5700
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Amini Elham¹,Berger Simon M.¹,Schilling Uta¹,Jiao Yuanyuan²,Chen Mong-Jen¹,Bachhav Sagar¹,Baumstein Sandra M.²,Tang Yufei¹,Al-Humiari Mohammed³,Leon Astudillo Carmen E.³,Drescher Stefanie¹,Iley Teresa⁴,Shur Jagdeep⁵,Price Robert⁵,Carrasco Cynthia⁶,Conti Denise S.⁷,Delvadia Renishkumar⁷,Oguntimein Oluwamurewa⁷,Witzmann Kimberly⁷,Absar Mohammad⁷,Luke Markham C.⁷^ORCID,Boc Susan⁷,Dhapare Sneha⁷,Saluja Bhawana⁷,Bielski Elizabeth⁷,Newman Bryan⁷,Bulitta Jürgen B.²,Hochhaus Günther¹^ORCID

Affiliation:

1. Department of Pharmaceutics, College of Pharmacy, University of Florida, 1345 Center Drive, Gainesville, Florida 32610, United States

2. Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, 6550 Sanger Road, Orlando, Florida 32827, United States

3. Division of Pediatric Pulmonary and Sleep Medicine, Department of Pediatrics, College of Medicine, University of Florida, Gainesville, Florida 32610, United States

4. Intertek Melbourn, Melbourn Herts SG8 6DN, UK

5. Nanopharm Ltd, an Aptar Pharma Company, Cavendish House, Newport, NP10 8FY, UK

6. Worldwide Clinical Trials, Austin, Texas 78744, United States

7. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland 20993, United States

Funder

U.S. Food and Drug Administration

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.3c00553

Reference25 articles.

1. Bioequivalence for Locally Acting Nasal Spray and Nasal Aerosol Products: Standard Development and Generic Approval

2. U.S. Department of Health and Human Services Administration, FDA, CDER Guidance for Industry─Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action. April 2003.

3. Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?

4. Regulatory Considerations for Approval of Generic Inhalation Drug Products in the US, EU, Brazil, China, and India