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MAY 2022
Inhalation 1-2-3 A brief update from Inhaltion Magazine.

Reformulating pMDIs to reduce their global warming potential
imageGlobal warming potential (GWP) is a formulation challenge facing producers of pressurized metered dose inhaler (pMDI) systems across the globe. While a transition away from the use of chlorofluorocarbon (CFC) pMDI inhalers has eliminated ozone-depleting emissions associated with this type of propellant, the GWP of the hydrofluoroalkane (HFA)-based propellants currently used as the alternative is still considered too high. Pressure to produce pMDIs that help reduce the carbon footprint associated with respiratory care through the use of greener propellant alternatives is growing. More environmentally benign propellant alternatives, such as those with a reduced or near-zero GWP, offer a potentially promising solution.

However, no clear direction has been offered by regulators on an approach for pMDI re-formulation with a new propellant. It could be assumed that product re-formulation is approached in the same way as generic product development, that is, product safety and efficacy are assessed for equivalence against the current reference product. Global demand for pMDIs remains high, adding impetus to requirements for testing solutions that expedite re-formulation timelines. These re-formulated products must not only help us reduce the carbon footprint associated with respiratory care, but also ensure newly re-formulated products reach the hands of patients quickly and efficiently.

The Copley Scientific automated shake and fire range is designed to help accelerate product development timelines.

Copley Scientific
UK: +44 1159 616229

in focus

imageTesting dry powder inhalers (DPIs): Pulling back the curtain on the pharmacopeial DPI flow system and thinking critically about it
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 of this article believe these include specifications for the solenoid valve, the effect of the pre-separator, control of the flow rate and measurement of the flow rate. They think critically about the motion of air from the moment the solenoid valve gets its signal to open until the solenoid valve closes and the air motion comes to a halt. They also consider the fact that there are particles in the system, not just air. In addition, they describe ongoing investigations of remaining uncertainties in the testing equipment and methods. Their hope is that each reader who has a question can better think through any issue after reading this article.


imageMerging pharmacopeial and clinically relevant oral inhaler testing streams: All or nothing or is there a middle way?
A large gap exists between the relatively straightforward robust methods in the pharmacopeias, developed primarily for product release, and the more elaborate approaches to assist in understanding how inhalers are likely to perform in the hands of the patient or caregiver. In this article, the authors propose that there is a middle way forward and believe it is possible to retain robustness in methodologies, while achieving significant gains in clinical realism. Rather than simply separating methodologies into pharmacopeial and clinically relevant groupings, the ways that OIPs can be tested have been divided into three separate streams: a) existing quality control methods in the pharmacopeial compendia, b) augmented quality control methods aiming to improve clinical realism and c) procedures involving further enhancements to optimize clinical relevance. In addition, the authors have broken down each category into the following attributes that help define the scope of each approach: 1) method capability, 2) applicability, 3) regulatory considerations, 4) management considerations and 5) analytical considerations.
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