Scientific and regulatory activities initiated by the US food and drug administration to foster approvals of generic dry powder inhalers: bioequivalence perspective
Regulatory science for generic dry powder inhalers (DPIs) in the United States (US) has
evolved over the last decade. In 2013, the US Food and Drug Administration (FDA) …
evolved over the last decade. In 2013, the US Food and Drug Administration (FDA) …
In vitro-in vivo correlation of cascade impactor data for orally inhaled pharmaceutical aerosols
In vitro-in vivo correlation is the establishment of a predictive relationship between in vitro
and in vivo data. In the context of cascade impactor results of orally inhaled pharmaceutical …
and in vivo data. In the context of cascade impactor results of orally inhaled pharmaceutical …
In Vitro Tests for Aerosol Deposition. VI: Realistic Testing with Different Mouth–Throat Models and In Vitro—In Vivo Correlations for a Dry Powder Inhaler, Metered …
Background: In vitro—in vivo correlations (IVIVC) for lung deposition may be established by
testing inhalers in vitro with realistic mouth–throat (MT) models and inhalation profiles (IP) …
testing inhalers in vitro with realistic mouth–throat (MT) models and inhalation profiles (IP) …
Realizing Lobe-Specific Aerosol Targeting in a 3D-Printed In Vitro Lung Model
Background: Delivery of aerosols to isolated lobes of the lungs would be beneficial for
diseases that have lobe-specific effects, such as cancer, pneumonia, and chronic obstructive …
diseases that have lobe-specific effects, such as cancer, pneumonia, and chronic obstructive …
Can pharmacokinetic studies assess the pulmonary fate of dry powder inhaler formulations of fluticasone propionate?
In the context of streamlining generic approval, this study assessed whether
pharmacokinetics (PK) could elucidate the pulmonary fate of orally inhaled drug products …
pharmacokinetics (PK) could elucidate the pulmonary fate of orally inhaled drug products …
Characterization of excipient enhanced growth (EEG) tobramycin dry powder aerosol formulations
Spray drying can be utilized to produce highly dispersible powder aerosol formulations.
However, these formulations are known to be hygroscopic, leading to potential solid-state …
However, these formulations are known to be hygroscopic, leading to potential solid-state …
Evaluation of bio-relevant mouth-throat models for characterization of metered dose inhalers
For inhalation drug characterization, the traditionally used USP induction port provides
limited in vivo predictive capability because it does not adequately mimic airway geometry …
limited in vivo predictive capability because it does not adequately mimic airway geometry …
Combined in vitro-in silico approach to predict deposition and pharmacokinetics of budesonide dry powder inhalers
CA Ruzycki, B Murphy, H Nathoo, WH Finlay… - Pharmaceutical …, 2020 - Springer
Purpose A combined in vitro–in silico methodology was designed to estimate
pharmacokinetics of budesonide delivered via dry powder inhaler. Methods Particle size …
pharmacokinetics of budesonide delivered via dry powder inhaler. Methods Particle size …
Models of deposition, pharmacokinetics, and intersubject variability in respiratory drug delivery
Introduction: Aerosol drug delivery to the lungs via inhalation is widely used in the treatment
of respiratory diseases. The deposition pattern of inhaled particles within the airways of the …
of respiratory diseases. The deposition pattern of inhaled particles within the airways of the …
Bioequivalence assessment of pharmaceutical aerosol products through IVIVC
D Sandell - Advanced Drug Delivery Reviews, 2021 - Elsevier
Many pharmaceutical developers of generic orally inhaled products (OIPs) are facing
significant issues in passing the regulatory requirement to show pharmacokinetic (PK) …
significant issues in passing the regulatory requirement to show pharmacokinetic (PK) …