Soft mist inhaler (SMI) low velocity sprays enable superior deep lung deposition without the need for propellants. However, to efficiently develop a generic SMI product, tests that account for their unique characteristics must be adopted. Due to the low spray velocity and high spray duration of SMI products, the United States Food and Drug Administration (FDA) has suggested the use of spray velocity and spray duration in bioequivalence testing (FDA Product-Specific Guidance for Tiotropium Bromide).

Advanced aerosol characterization services can reduce or remove barriers to generic drug development. Based on a recognized laser diffraction method, plume front velocity measures the leading edge of an aerosol plume, quickly and accurately creating velocity profiles from a single actuation. In addition, spray duration measures the difference in time between the beginning and end of a spray actuation. These tests can satisfy regulatory requirements and indicate
non-equivalent deposition and therapeutic effect.

Proveris Laboratories
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Maintaining that ability to estimate total and regional lung deposition is essential in the design of efficient orally inhaled products, the authors of this August magazine article discuss a series of in vitro test methods. They also describe a new, filter-based apparatus that mimics the aerodynamic particle size and flow rate dependencies of regional lung deposition. The apparatus is intended to alleviate the complexity and resource burden of cascade impactor-based in vitro/in silico methods used to estimate regional lung deposition. For both DPIs and pMDIs, the approach has provided direct measurement of regional deposition in good agreement with in vitro/in silico estimates made using an Alberta Idealized Throat (AIT), a Next Generation Impactor (NGI), and the Aerosol Research Laboratory of Alberta's in-house regional deposition modeling software. The approach has the potential to expedite research and development of novel orally inhaled products aiming to target tracheobronchial or alveolar regions of the lungs, as well as comparisons of equivalence between innovator products and generics.

In 1999, an inaugural meeting of experts from 10 pharmaceutical companies was held and the name "European Pharmaceutical Aerosol Group (EPAG)" was agreed upon. By 2002, EPAG had expanded to 16 companies. This August magazine article provides a brief history of the formation of EPAG, including its constitution, objectives, structure, influence, publications and input to regulatory guidance documents. A list of the organization's publications and references since 2000 is also included. The large body of published articles coming from EPAG, together with the influence exerted externally in the community of stakeholders associated with OINDPs, are strong evidence that the organization has met and continues to meet its goals and objectives defined at the outset and revised regularly in the 5-year plan for the group. The continued existence of EPAG confirms the original concept from 1999 that industry is able and stronger when it works together to deliver much-needed OINDPs.

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Drug Delivery to the Lungs 2023

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inhalationmag.com/industry-organizations

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