Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?
Administration, Inhalation
Adolescent
Adult
Aerosols
Area Under Curve
Bronchodilator Agents
/ administration & dosage
Cross-Over Studies
Double-Blind Method
Drug Liberation
Drugs, Generic
/ administration & dosage
Dry Powder Inhalers
Female
Fluticasone
/ administration & dosage
Healthy Volunteers
Humans
Male
Middle Aged
Powders
Therapeutic Equivalency
Young Adult
bioequivalence of generic inhaled drugs
dry powder inhalers
fluticasone propionate
pharmacokinetics
regional lung deposition
Journal
The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209
Informations de publication
Date de publication:
25 03 2021
25 03 2021
Historique:
received:
03
10
2020
accepted:
06
02
2021
entrez:
26
3
2021
pubmed:
27
3
2021
medline:
30
11
2021
Statut:
epublish
Résumé
In the context of streamlining generic approval, this study assessed whether pharmacokinetics (PK) could elucidate the pulmonary fate of orally inhaled drug products (OIDPs). Three fluticasone propionate (FP) dry powder inhaler (DPI) formulations (A-4.5, B-3.8, and C-3.7), differing only in type and composition of lactose fines, exhibited median mass aerodynamic diameter (MMAD) of 4.5 μm (A-4.5), 3.8 μm (B-3.8), and 3.7 μm (C-3.7) and varied in dissolution rates (A-4.5 slower than B-3.8 and C-3.7). In vitro total lung dose (TLD
Identifiants
pubmed: 33768368
doi: 10.1208/s12248-021-00569-x
pii: 10.1208/s12248-021-00569-x
pmc: PMC10662255
mid: NIHMS1942910
doi:
Substances chimiques
Aerosols
0
Bronchodilator Agents
0
Drugs, Generic
0
Powders
0
Fluticasone
CUT2W21N7U
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
48Subventions
Organisme : FDA HHS
ID : U01 FD004950
Pays : United States
Organisme : FDA HHS
ID : U01 FD005231
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001427
Pays : United States
Commentaires et corrections
Type : ErratumIn
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