Oz-UK Ltd announces new low-GWP manufacturing line installation to meet global need for pMDIs ahead of the Kigali Amendment deadline

Oz-UK Ltd, the Chippenham-based contract research organization (CRO) dedicated to providing pressurized metered dose inhaler (pMDI) and liquid aerosol research and development (R&D), announces the installation of its new low-GWP (global warming potential) manufacturing line to meet global needs for pMDI investigation ahead of the Kigali Amendment deadline.

The announcement – made at the Drug Delivery to the Lungs (DDL) conference in Edinburgh from 6-8 December 2023 – tackles head-on the pharmaceutical industry concern for phase-down of the use of fluorinated gases (F-gases) by 2047, stipulated by the Kigali Amendment. F-gas regulations have a significant impact on the market for inhalation products and switching to propellants with a lower GWP is a commercial imperative for pharmaceutical manufacturers.

The new low-GWP line – funded in part by Oz-UK and in part by grants from Wiltshire Council through the UK Government’s Prosperity Funds – is located in one of Oz-UK’s two custom-built facilities in Chippenham, Wiltshire, and will be operational by July 2024. The new low-GWP line will add to the current client development services for low-GWP solution and suspension pMDI development programmes. The line will manufacture pMDIs containing HFO-1234ze and HFA-152a propellants and will allow 2.5 – 10-kilogram batches to be manufactured.

As the pharmaceutical industry attempts to develop viable alternatives, these need to be trialled in new formulations and new devices to comply with the phase-down. Currently, R&D is focusing on moving away from the two most common HFA propellants, 134a and 227ea, and towards low-GWP HFA and HFO propellants, such as 152a and 1234ze, both of which the new Oz-UK manufacturing line is designed to accommodate. Low-GWP alternatives exhibit different physiochemical properties to their predecessors, which can impact the stability and spray formation associated with the formulation. Therefore, significant amount of R&D is needed to support the transition to next generation propellants for pMDIs. Oz-UK, which already offers formulation development services to the pharmaceutical, biotechnology and cannabinoid industries, is rapidly investing in its facilities to keep up with global demand for R&D, formulation and pilot production capabilities.

Dr. David Lewis, Director of Oz-UK explains: “Development of inhalation products is limited by the difficulties of R&D in a pressurised environment and the propellant propulsion challenges of aerosol science. Our years of experience in this market mean that Oz-UK is uniquely positioned to support pharma at speed, with the facilities needed to undertake the R&D, formulation, and pilot testing of new pMDIs. We are already working on technical transfer and intellectual property (IP) transfer for a number of global businesses who have carried out this work with us, including Recipharm who also announced a collaboration with Oz-UK for its initiative to accelerate the development and manufacture of “green” pMDIs. The introduction of our new low-GWP line will enable more companies to undertake these projects more quickly as the deadline for F-gas phase-down approaches.”

Oz-UK is rapidly investing in its existing facilities and development formulation services now include 10 litre mixing vessels and Pamasol suspension filling equipment. Uniquely, Oz-UK has both a schedule 1 & 2 Controlled Drugs Licence, enabling pMDI development work for a wide range of active pharmaceutical ingredients (APIs), within a regulated environment.

Pharmaceutical and cannabinoid companies with R&D projects in aerosol propellant replacement, formulation design and IP submissions in inhalation are now able to manage the drug development project in a fully outsourced environment at Oz-UK before scale-up to manufacture in-house.

For more information, please contact Oz-UK on info@oz-uk-labs.com.