JULY 2021
Inhalation 1-2-3 A brief update from Inhaltion Magazine.

Capsules properties—for use in dry powder inhalers
imageCapsules used in dry powder inhalers must support good powder emptying, aerosolization and drug delivery. Therefore, such capsules must have appropriate mechanical properties, low moisture content and a controlled lubricated surface. Additional requirements include optimal puncturing and aerosolization properties as well as minimal microbial levels and reduced static charge. Further, inhaled drugs are often moisture-sensitive. Moisture may promote agglomeration of drug particles, thereby decreasing the fine particle fraction, important to aerosolization. Inhalation-grade hydroxypropyl methylcellulose (HPMC)/carrageenan capsules can have a low moisture content of 4.5 - 6.5%, which may be further reduced without influence on mechanical properties, as these plant-based capsules do not become brittle in arid conditions. For more information.

Qualicaps® Europe, S.A.U.
Spain: +34 91 6 63 0 800

in focus

imageExploring new pMDI propellants for a greener future
The Kigali Amendment to the Montreal Protocol aims to phase-down global HFA consumption. While volumes of hydrofluoroalkane (HFA) gases used by the inhalation and respiratory healthcare industry are relatively small, it is likely we will see supply shortages in the future as other industries completely phase out their use. Consequently, there is a need to adopt more environmentally friendly pMDI propellants. HFA-152a and HFO-1234ze(E) are two potential candidates. It is critical that drug developers and manufacturers prepare their facilities for the use of these propellants, considering factors such as container closure compatibility, flammability and challenges in process development and scale-up. This June magazine article discusses ways the inhalation industry can be ready to adopt new propellants to guarantee continued, reliable manufacture and supply of vital medicines for patients.


imageHow critical quality attributes of the drug substance can support orally inhaled and nasal drug product (OINDP) quality
The FDA's Draft Guidance for Industry, "Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products - Quality Considerations" discusses quality attributes for metered dose inhalers and dry powder inhalers. Regardless whether pursuing innovator or generic product development, the importance of establishing a desired quality target product profile (QTPP) is highlighted, to define the characteristics of the drug product that ideally will be achieved. This June magazine article presents case studies and highlights ways key physical properties of drug substance particles might be adjusted and measured to meet a QTPP. Morphic form, particle shape and surface characterization were studied and a variety of analytical techniques were used. Characterization results for fluticasone propionate, fluticasone furoate, vilanterol trifenatate and/or salmeterol xinafoate powders, micronized by jet milling and/or wet polishing, and various process parameters for the techniques, are discussed.

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imageInformation on upcoming industry events
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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