Low GWP Propellants
Converting existing pMDIs to more sustainable products, with lower Global Warming Potential (GWP) propellants, requires extensive development and reformulation work. Nanopharm’s expertise in OINDP reformulation and analytical services, with specialized capabilities and technologies, can assist in this scope of work. This involves optimizing the metering valve itself and modifying formulations so that the pMDI product can still deliver the drug product with equivalent performance to the existing marketed product.
Pressurized Metered-dose inhalers and Lower GWP Propellants
Pressurized Metered-dose inhalers (pMDIs) are a widely used and trusted drug delivery technology for a range of respiratory conditions. pMDIs are pressurized with a gas propellant that powers a consistent plume of drug formulation to a patient’s lungs with each actuation of the device. The current gas propellants are reliable and approved but may contribute to global warming. Therefore, newer, and more sustainable, lower global warming potential (GWP) propellant options are being researched that can reduce the environmental impact of pMDIs without compromising product performance. Nanopharm works with their customers to provide complete development programs and regulatory support needed to bring more sustainable pMDI products to market.
Nanopharm is experienced in the development of pMDIs using more sustainable lower Global Warming Potential (GWP) propellants. We offer complete pMDI development services using lower GWP propellants including metering valve and device optimization along with integrated formulation and product development services.
Nanopharm develops scalable and manufacturable pMDI solutions using lower GWP propellants that can be manufactured from bench to cGMP pilot scale at our partners’ facilities and internally using our 8L pilot scale mixing and filling line.
Nanopharm’s parent company, Aptar Pharma, is a global leader in pMDI metering valve technology.
pMDI Development with Lower GWP Propellants
Propellants used in medical devices have come under new and tighter regulations designed to reduce their environmental and Global Warming Potential (GWP) impact. As a result, many companies have targeted the reduction of traditional HFA or HFC propellant use in medical devices by 85%, no later than 2047. Both patient safety and functional drug delivery must be demonstrated as equivalent before existing products can be converted to use ones containing lower GWP propellants. HFA P152a and HFO1234ze are leading propellant candidates to replace the older propellants because of their considerably lower global warming potential (GWP). Nanopharm is committed to working with customers to reformulate their products using more environmentally friendly propellants. Nanopharm’s scientists bring together their knowledge of metering valve design, pMDI device technology and inhalation formulation approaches that result in robust pMDI products using lower GWP propellants. With its analytical tools to characterize changes to the plume dynamics and aerosol properties, coupled with its unique in-vitro in-silico modeling approaches covering lung deposition models and PBPK simulations, Nanopharm makes sure the pMDI can still deliver the drugs effectively.
Scalable to Manufacturing
We can take low GWP pMDIs from bench-top to manufacturing, through pilot scale at our ATEX rated mixing and filling facility located in Europe, that was designed to handle new lower GWP propellant candidates. We develop pMDI products with manufacturability and performance in mind from the very start of the development process. Nanopharm works with cGMP manufacturing partners partners tech transfer pMDIs with lower GWP propellants for clinical studies or commercialization scales.
pMDI Devices and Valves
Nanopharm’s parent company, Aptar Pharma, is a long-established manufacturer and designer of pMDI metering valves. Nanopharm can access Aptar’s portfolio of advanced metering valves, in combination with our well recognized scientific and regulatory support for pMDI technologies for an integrated development approach. Nanopharm scientists can also develop optimized formulations that will work with the selected metering valve and pMDI technology pairing. The objective is always to arrive at a fully functional and scalable pMDI product that meets customer’s sustainability objectives.
