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 (OIDPs). Three fluticasone propionate (FP) dry powder inhaler (DPI) formulations (A-4.5, B-3.

CFD Guided Optimization of Nose-to-Lung Aerosol Delivery in Adults: Effects of Inhalation Waveforms and Synchronized Aerosol Delivery.

Purpose: The objective of this study was to optimize nose-to-lung aerosol delivery in an adult upper airway model using computational fluid dynamics (CFD) simulations in order to guide subsequent human subject aerosol delivery experiments.

Methods: A CFD model was developed that included a new high-flow nasal cannula (HFNC) and pharmaceutical aerosol delivery unit, nasal cannula interface, and adult upper airway geometry. Aerosol deposition predictions in the system were validated with existing and new experimental results.

Team teaching with pharmacy practice and pharmaceutics faculty in a nonsterile compounding laboratory course to increase student problem-solving skills.

Background And Purpose: Combining pharmaceutics and pharmacy practice into nonsterile compounding is ideal to increase problem-solving skills. The objectives of this activity were to: (1) create a nonsterile compounding activity through a team-teaching collaboration, (2) increase students' independent problem-solving skills to compound a nonsterile natural product, and (3) assess student and faculty perceptions of the learning activity.

Educational Activity And Setting: The activity was created, implemented, and assessed using a team-teaching technique between pharmacy practice and pharmaceutics faculty.

Measurement of Regional Nasal Drug Delivery with Flonase, Flonase Sensimist,™ and MAD Nasal™ in Anatomically Correct Nasal Airway Replicas of Pediatric and Adult Human Subjects.

The majority of current nasal delivery devices, commercialized for children, are developed for adults. Differences in the dose reaching the target are expected due to significant differences between the pediatric and adult nasal airway geometries and their inhalation patterns. This study aims to compare the efficacy of most common nasal drug delivery devices in terms of regional delivery of suspension and solution formulations in pediatric and adult subjects.

Development of a High-Flow Nasal Cannula and Pharmaceutical Aerosol Combination Device.

Aerosol drug delivery to the lungs is known to be very inefficient during all forms of noninvasive ventilation, especially when the aerosol is administered simultaneously with high-flow nasal cannula (HFNC) therapy. The objective of this study was to develop a new combination device based on vibrating mesh nebulizers that can provide continuously heated and humidified HFNC therapy as well as on-demand pharmaceutical aerosols with high efficiency. The combination device implemented separate mesh nebulizers for generating humidity (humidity nebulizer) and delivering the medical aerosol (drug nebulizer).

Tests for Aerosol Deposition. VI: Realistic Testing with Different Mouth-Throat Models and Correlations for a Dry Powder Inhaler, Metered Dose Inhaler, and Soft Mist Inhaler.

correlations (IVIVC) for lung deposition may be established by testing inhalers with realistic mouth-throat (MT) models and inhalation profiles (IP). This study was designed to compare the currently available MT models and their ability to predict lung deposition. Budelin Novolizer, Ventolin Evohaler, and Respimat fenoterol were chosen to represent a dry powder inhaler (DPI), metered dose inhaler (MDI), and soft mist inhaler (SMI) in tests using eight MT models: small, medium, and large Virginia Commonwealth University (VCU) models; small, medium, and large oropharyngeal consortium (OPC) models, the medium adult Alberta Idealized Throat (AIT), and the United States Pharmacopeia (USP) Induction Port, with IPs that simulated those used by volunteers in lung scintigraphy studies.

Predicting Pulmonary Pharmacokinetics from In Vitro Properties of Dry Powder Inhalers.

Purpose: The ability of two semi-mechanistic simulation approaches to predict the systemic pharmacokinetics (PK) of inhaled corticosteroids (ICSs) delivered via dry powder inhalers (DPIs) was assessed for mometasone furoate, budesonide and fluticasone propionate.

Methods: Both approaches derived the total lung doses and the central to peripheral lung deposition ratios from clinically relevant cascade impactor studies, but differed in the way the pulmonary absorption rate was derived. In approach 1, the rate of in vivo drug dissolution/absorption was predicted for the included ICSs from in vitro aerodynamic particle size distribution and in vitro drug solubility estimates measured in an in vivo predictive dissolution medium.

In Vitro Tests for Aerosol Deposition. V: Using Realistic Testing to Estimate Variations in Aerosol Properties at the Trachea.

Background: The dose and aerodynamic particle size distribution (APSD) of drug aerosols' exiting models of the mouth and throat (MT) during a realistic inhalation profile (IP) may be estimated in vitro and designated Total Lung Dose, TLD, and APSD, respectively. These aerosol characteristics likely define the drug's regional distribution in the lung.

Methods: A general method was evaluated to enable the simultaneous determination of TLD and APSD for budesonide aerosols' exiting small, medium and large VCU-MT models.

In Vitro Tests for Aerosol Deposition. IV: Simulating Variations in Human Breath Profiles for Realistic DPI Testing.

Background: The amount of drug aerosol from an inhaler that can pass through an in vitro model of the mouth and throat (MT) during a realistic breath or inhalation flow rate vs. time profile (IP) is designated the total lung dose in vitro, or TLDin vitro. This article describes a clinical study that enabled us to recommend a general method of selecting IPs for use with powder inhalers of known airflow resistance (R) provided subjects followed written instructions either alone or in combination with formal training.