With the finalizing of the Montreal protocol in 1987, the directive to start phasing out the production and use of ozone depleting products such as chlorofluorocarbons and halons was issued. This change spurred technological advancements to develop new options for refrigerants and propellants commonly used in refrigerators, air conditioners, and inhalers with a low ozone-depleting propellant. In 2016, the Kigali Amendment was adopted to the Montreal Protocol to reduce gradually the use of hydrofluorocarbons (HFC) worldwide. The Global Warming Potential (GWP) is used to measure negative impact on the climate. To adapt to this change, medical device manufacturers are migrating current inhalers to use only low GWP propellants. This has massive implications for the entire inhaled pharmaceutical industry.
The first step in the change is understanding the characteristics of the new propellant and what needs to be done to accommodate these changes. This Webinar will focus specifically on the spray characteristics of the current P134a propellant, and one low GWP propellant, P152a. To gain a more complete understanding of the behavior of a device with a new formulation, additives such as Ethanol, to assist solubility, must be included in the evaluation. In the webinar we will include a comparison of shot weights, Spray Pattern, and Plume Geometery and a discussion to understand the performance of each of these propellants.
Once a baseline is established, the next level of investigation will include the addition of an API, salbutamol. Using human-realistic In Vitro Drug Analysis, the regional deposition will be assessed in a Mouth-Throat-Lung model followed by extraction and HPLC analysis for quantitation. A comparison of the data will be discussed to understand how different propellants can affect the deposition of the API in the Mouth-Throat-Lungs.
These comparative studies can assist in an understanding of the spray characterization of the current P134a to a low GWP such as P154a. Using human-realistic conditions to determine deposition can mitigate risk early in development by illustrating any potential challenges that may cause setbacks later in development.
Join us for our webinar to review options for reformulation using a current propellant and a low GWP propellant and evaluating the results.
Learning Objectives:
- Understanding why propellant changes are needed.
- Comparing Spray Pattern and Plume Geometry methods between propellants
- A comparison of Spray Pattern and Plume Geometry results for P134a and P152a, both with and without ethanol.
- Methods to mitigate the risk of propellant reformulation
