MARCH 2024
Inhalation 1-2-3 A brief update from Inhaltion Magazine.
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Bridging the gap for better in vivo predictions
imageImproving the clinical relevance of core in vitro tests such as delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD) is an important area of focus for both industry and regulators, largely due to the growing demand for generic OINDPs. Bridging the gap between data from compendial core test methods and in vivo performance will help more robustly confirm bioequivalence, an important goal for product developers seeking to optimize the efficiency of clinical programs through more representative in vitro measurements.

The clinical realism of core tests can be enhanced without overly compromising the reproducibility and utility of the test methods. For example, the Alberta Idealised Throat with its human-like internal geometry simulates dose deposition behavior in the mouth-throat more closely during orally inhaled product testing. In addition, breathing simulators enable a detailed assessment of the impact of breathing profile on device performance during routine testing.

Copley Scientific Ltd
UK: +44 1159 616229
in focus

imageEnvironmentally friendly metered dose inhaler propellants: Challenges for inhaler design
In this article, the author and colleagues investigated how the change from current-generation to next-generation pMDI propellants might affect the technical performance of currently used pMDI hardware, with a focus on actuator designs that assist with achievement of in vitro equivalence.

The studies were divided into three broad categories: 1) Consideration of performance inside the canister including factors such as active pharmaceutical ingredient (API) solubility (for solutions), sedimentation or creaming time (for suspensions), material compatibility, and adhesion or loss of the drug onto the canister valve and wall surfaces (both physical forms). 2) Performance of the spray plume beyond the orifice, which drives spray pattern, plume geometry, droplet size and velocity. 3) Performance of the matured aerosol particles, as measured by their delivered dose and size distribution.

The key finding of the preliminary in vitro studies is that changes required to convert pMDI formulations from current HFAs to low-GWP alternatives require careful evaluation but do not represent an insurmountable barrier.

imageShell formers in the formulation design of spray-dried particles
There has been a surge in interest surrounding the development of carrier-free dry powder formulations intended for pulmonary drug delivery. Spray drying is the preferred technique for the production of carrier-free dry powder formulations. Shell forming excipients can play a pivotal role in overcoming challenges encountered with spray drying, related to particle cohesion, hygroscopicity and overall stability.

Due to their unique physico-chemical properties, this class of excipients can form a protective layer on the surface of the droplet during drying, resulting in core-shell structured particles. By strategically incorporating shell formers into spray-dried products, formulators can enhance dispersibility and mitigate the potential drawbacks associated with cohesive powders. This article delves into the multifaceted role of shell formers, shedding light on their mechanisms of action, impact on particle properties and a practical methodology for their formulation design.

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