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

What makes a generic inhaler successful?
imageThere are a few "must have" criteria needed to develop a fully substitutable, successful generic inhaler device. These criteria include equivalence in (1) size, (2) shape, (3) material, (4) resistance and (5) user handling steps, as well as (6) performance both in vitro and in vivo—which is very much dependent on the formulation. The Merxin MRX004 is one such successful device and is ready for human use. Its plume lasts 1.5 seconds and travels at 0.8 m/sec. It has a measuring chamber of 16 µL to deliver an aerosol with a fine particle fraction (FPF) in excess of 60% with a mass median aerodynamic diameter (MMAD) of 3-4 µm. These parameters make it a highly efficient method of delivering drugs to the lungs and achieving high deposition.

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in focus

imageQuality requirements for cascade impactors assigned to batch release testing of a specific drug product; Part III: Implications of Type II error probability
In this article, the authors conclude a three-part series describing a new approach to quality requirements for cascade impactors (CIs). Their thesis is that the inhaler testing community, both from the manufacturer and regulator perspectives, should insist that the CI quality specifications be both necessary and sufficient for the testing of batches of drug product for release of that product to the public. Ideally, they hope such methodology would guide developers of new OIPs in making proposals for impactor quality specifications to regulators. In turn, regulators need to assure that specifications are both necessary and sufficient for batch release testing in quality control. Parts I and II in the series are available in Inhalation's free article archive.

imageNasal drug delivery: Past, present and future perspectives
The author provides a brief history of nasal delivery devices and their applications then looks to potential uses in the future. Nasal drug delivery has been a mainstay for local indications since the late 1900s. Delivery systems have evolved from less-precise dosing systems to sophisticated devices designs able to protect formulations and achieve reliable dosing. Further advances are anticipated, including connected applications. In addition, intranasal administration has become a trusted route for rescue medications. In the future, unmet needs may also be addressed in niche patient populations. Article topics include device platforms, locally acting products, vaccines, systemic nasal drug delivery, patient considerations, regulatory considerations and future opportunities. The article also includes a table listing samples of US FDA-approved nasal products introduced between 1965 and 2020.
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imageInformation on upcoming industry events
Click for information on the following industry events:
  • RDD Europe 2021
  • 2021 ISAM Congress

Please visit the calendar on Inhalation's website for more conferences, which may change from live to virtual formats and have new dates due to COVID-19.
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Questions about Inhalation, contact Vicki Schuman, Editor at vschuman@cscpub.com.
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