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project info
Start date: 10 June 2020
End date: 30 March 2023
funding
Fund: European Regional Development Fund (ERDF)
Total budget: 11 572 943,00 €
EU contribution: 2 893 235,75 € (25%)
programme
Programming period: 2014-2020
Managing authority: Région Normandie
European Commission Topic

ERDF — APTAR — INHALATION PROJECT

Inhalers are portable devices used to deliver an active substance via the respiratory tract in the context of chronic obstructive pulmonary disease (COPD) or asthma. They are used in different contexts: • During a crisis treatment by rapidly dilating the bronchi; • During a deep treatment, to avoid further seizures, particularly affecting chronic inflammation of the bronchi. Inhalation devices offer significant benefits: •The effective dose is much lower than taking another type of treatment (tablets, injections, etc.), acting directly in the bronchi; •Being delivered directly at the bronchial level, the drug does not need to bedigerated and transported to act. It therefore acts quickly; • The drug passes little in the blood and body, thus limiting side effects. Today there are 2 types of main inhalers: • The dosing valve pressurised inhaler or MDI(Metered Dose Inhaler): the drug suspended in HFA is administered by pressing the cartridge, which releases a drug vaporiser at a specified dose. It is necessary to coordinate the inhalation of the patient with the activation of the inhaler. This is the only device that is suitable for crisis treatment; •Dry Powder Inhaler or DPI (Dry Powder Inhaler): these devices deliver medicinal products in the form of powder into the lungs via the inhaling force of the patient; After the pill, aerosol is the most used drug form in the world. The overall market for portable inhalers in June 2019 is 795 m units sold ($35 billion) per year. MDI is the category that represents the largest sales volume with 480 M units, i.e. 60 % of the market by volume. IPRs represent 36 % of the market volume. The market is growing globally. The most represented devices on the market, MDI, have a strong environmental impact due to the propeller gas they contain. Indeed, the propeller gas is a liquefied compressed hydrofluoroalkane, HFA 134a, a gas with high environmental impact. Thus, MDI accounted for 2.4 % of HFC emissions in 2015. Therefore, even if the pharmaceutical industry has a derogation to use fluorinated gases for these inhalers, it is at risk. Recent European regulations to control emissions from F-gases perfectly illustrate this threat. Similarly, the available HFA 134a quotas are decreasing: 65 % between 2015 and 2030 with prices rising at the same time: x6between 2014 and 2019. Faced with this unfavourable context for HFA 134a, Aptar PHARMAsouhaite will take a technological shift through its “Inhalation” project, developing a new technology for MDI-type inhalation devices, with a less harmful propellant gas with equivalent efficiency and user experience. The new propeller gas used will be the HFA 152a, reducing the environmental impact by 90 %. This device will be developed to treat asthma attacks and bronchospasms with salbutamol. The “Inhalation” R&D project has two areas of innovation: 1. Define a new technology dedicated to HFA152a: the objective will be to develop a new metering valve associated with the HFA 152a and to identify the materials to be used to ensure the performance and safety of the device; 2. Adapting the new ausalbutamol technology: identify and develop the appropriate formulation to ensure the therapeutic effectiveness of salbutamol against asthma attacks andbronchospasms and adapt the technology to the flammability constraints of HFA152a and thus allow safe conditioning.

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