Proveris to Present: The Effect of Ethanol Concentration on pMDI Evaporation Fraction

Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, recently announced that on April 26 at the RDD 2020 Digital Respiratory Drug Delivery Conference, Proveris will present a joint poster with H&T Presspart, Blackburn, Lancashire, UK entitled, The Effect of Ethanol Concentration on pMDI Evaporation Fraction.

The subject of the study is introducing a technique to quantify the evaporation fraction using a novel measurement method applied to a time-synchronized image sequence of the aerosol spray from pressurized metered dose inhalers (pMDIs). In order to demonstrate the effectiveness of the technique, the study used non-commercial pMDI product samples with three different ethanol concentrations, but identical devices provided by H&T Presspart. The results show the higher the ethanol concentration, the lower the evaporation fraction.

The FDA May 2019 product specific guidance for beclomethasone dipropionate delivered by MDI lists evaporation rate of the aerosol as an in vitro characterization study that is representative and/or predictive of the clinical effect in the deep lung. Due to the aerosolization mechanism of pMDI products, aerodynamic properties such as evaporation rate impact drug delivery and lung deposition. Currently, there are limited evaporation rate studies and technologies available to effectively study the variable bulk mass of aerosols without interrupting the spray.

The non-impaction laser imaging technology of the well-established Proveris SprayVIEW^® measurement system offers meaningful insight into drug product evaporation. The approach is significant as it offers Generic OINDP developers a tool for performing in vitro bioequivalence comparisons between Test and Reference products.

Proveris Scientific Corporation advances the science of respiratory drug delivery products by driving new technology development for high performance spray characterization, capture, and analysis, while leveraging its expertise, experience, and core technologies. With customer success as its central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” which include product innovation, technical services, systems, consumables, and educational training. Since its founding in 1995, the company has accelerated the development of top spray and aerosol drug products and has deployed its systems at more than 100 pharmaceutical development and manufacturing sites around the globe. Proveris’s systems are the industry standard and are used by the FDA, China NMPA (National Medical Products Administration), and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TUV Rheinland of North America, Inc., and has more than 20 patents issued on its technology

 H&T Presspart is a pharmaceutical component and device manufacturer for the respiratory drug delivery market, specializing in high-precision injection moulded plastic and deep-drawn metal components. With more than 40 years’ experience, H&T Presspart has a worldwide reputation for competence, quality and innovation in the respiratory drug delivery market. As the healthcare and pharmaceutical sectors continue to evolve, bringing revolutionary drugs to the market, H&T Presspart’s wealth of experience and expertise helps clients in the pharmaceutical industry make the best decisions early in the product and device development process. H&T Presspart’s Inhalation Product Technology Centre (IPTC) supports our customers’ new product developments and strategic initiatives. Founded in 1970 and acquired by the Heitkamp and Thumann group in 2002, H&T Presspart has 3 European manufacturing sites with sales offices around the world.