• June 10, 2024

Nasal powders have been recognized as an opportunity to improve stability and residence time on the nasal mucosa compared with liquids, where amorphous powders favor the formulation of poorly soluble drugs with improved biopharmaceutical profile, namely faster onset of action. This article presents two case studies focused on particle engineering strategies and nasal powder formulation […]

Nasal powder formulations represent a significant stride in drug delivery innovation, offering the potential for simplified, preservative-free compositions. Increased chemical stability and enhanced capacity for higher drug loads are additional benefits offered by formulating as a dry powder. Application of established production technologies, such as spray drying, allows for the design and manufacture of readily […]

  • April 5, 2024

This article describes the development and validation of the Alberta Idealised Nasal Inlet (AINI), illustrating its use within existing test set-ups. It also discusses three experimental studies that demonstrate: 1) the ability of the AINI to capture in vivo deposition behavior for different nasal drug products, 2) use of the AINI to assess and optimize […]

Oddly missing from the pharmacopeial compendia and archival literature are flow resistance data for glass microfiber filters common to the delivered dose uniformity (DDU) testing protocols described in the USP and European Pharmacopeias. The authors undertook a laboratory investigation to provide insight into how filter flow resistance can vary across several similar products available commercially. […]

  • December 1, 2023

In the first article, we explored the robustness of the pharmacopeial methodology for the determination of delivered dose uniformity (DDU) for orally inhaled products to bias in volumetric flow rate setting from variations in ambient pressure. In this article, we extend the analysis to evaluate how the determination of the second performance-related critical quality attribute, […]

  • October 17, 2023

In 2020 and 2021, Inhalation published three articles by the Cascade Impaction Working Group of the International Pharmaceutical Aerosol Consortium for Regulation and Science (IPAC-RS): (1) The liability of fine particle dose (FPD); (2) Cascade impactor stage groupings: Poor decisions from degraded data; and (3) Efficient data analysis (EDA): Size, mass and common sense. In […]

  • August 10, 2023

The article describes a series of in vitro test methods that can be used to estimate the total and regional lung doses. The focus of the discussion is on research and development, with the view that the ability to estimate total and regional lung deposition is essential in the design of efficient orally inhaled products. […]

  • April 7, 2023

Much improvement has taken place in evaluating sources of variability in the measures of delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD). Methods described in the United States Pharmacopeia (USP) and European Pharmacopoeia (Pharm. Eur.) now include dimensions and diagrams for all components critical to their robustness. However, we show that there are […]

  • August 14, 2022

CFD modeling for product development requires knowledge of the capabilities of state-of-the-art software and the adoption of a well-controlled simulation workflow. This article will review previous work in this area, illuminating CFD capabilities and the processes and considerations required to create a trusted, useful, predictive simulation to support the product development process. This article shows […]

  • April 8, 2022

Considering flow conditions in the DPI test system has led to understanding more about why experts have improved the pharmacopeial protocol over time. Still, there are aspects of the fundamentals that are not yet clarified but worth understanding and accommodating in the protocols. The authors believe these include specifications for the solenoid valve, the effect […]