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

The evolution of in vitro/in vivo correlation (IVIVC)
imageThere are countless unknowns and, therefore, inherent risks in drug development, from product quality control to clinical or PK/PD studies. Typically, when developers are able to precisely control more patient variables, there will be fewer surprises (and less cost!) when clinical trials get under way. Several of these historically considered "in vivo" variables, not currently captured in standard Pharmacopeial testing, can now be reliably repeated in the laboratory—including replicating actual patient breathing conditions and patterns, using more realistic anatomical geometries, and simulating dissolution rates in the patients' lungs. MSP, a Division of TSI, provides this equipment to help prevent unexpected problems in drug development.

MSP, a Division of TSI
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in focus

imageCascade impactor stage groupings: Poor decisions from degraded data
In the August magazine, the second article in a series from the IPAC-RS Cascade Impaction Working Group explores the limitations of stage groupings, probing whether they are suitable for making batch disposition decisions based on inhaler performance testing. The authors suggest impaction data is fundamentally flawed and ineffective because individual stage groupings do not adequately account for both dimensions of the size-fractionated mass comprising the APSD, and their combined use compounds this weakness to dramatic effect. Clearly, they say, stage groupings cannot be relied upon for batch-disposition decisions and are therefore a liability to the guarantee of safe and efficacious medicine for the patient. (The article has been updated to correct labeling of Figure 5.) Click to read the first article in the series, "The Liability of Fine Particle Dose (FPD)."

imageParticle engineering approaches for dry powder inhalers
Drug developers can use bottom-up or top-down particle engineering approaches or a combination, according to this August magazine article. Selecting the best approach depends on characteristics of the active pharmaceutical ingredient and the target product profile, including the inhaled biopharmaceutical classification of the drug in development. While multiple particle engineering approaches are available, spray drying and jet milling are proven, scalable approaches and drug developers may benefit from considering them as a first pass. By evaluating these initially, developers can determine whether a more complicated approach is required and which path is best suited for the active pharmaceutical ingredient and treatment. If multiple particle engineering technologies are suitable, developers can optimize for speed to patient and take into consideration the process throughput, yield and equipment availability.
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imageInformation on upcoming industry events
Please visit the calendar on Inhalation's website for a list of upcoming conferences, many of which are virtual and may have new dates due to COVID-19.
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