Oz-UK Ltd, a contract research organization (CRO) specializing in pressurized metered dose inhaler (pMDI) and liquid aerosol research and development (R&D), has announced the installation of a new manufacturing line with low global warming potential (low-GWP). This initiative aims to address the pharmaceutical industry's concerns about the Kigali Amendment's deadline for the phase-down of fluorinated gases (F-gases) by 2047. The announcement was made during the Drug Delivery to the Lungs (DDL) conference in Edinburgh from December 6-8, 2023.
The pharmaceutical industry is actively responding to the Kigali Amendment's regulations, which significantly impact the market for inhalation products. Transitioning to propellants with lower GWP is now a commercial necessity for pharmaceutical manufacturers.
Funded partially by Oz-UK and through grants from Wiltshire Council via the UK Government's Prosperity Funds, the new low-GWP manufacturing line is situated in one of Oz-UK's two custom-built facilities in Chippenham, Wiltshire. It is set to be operational by July 2024, contributing to Oz-UK's current client development services for low-GWP solution and suspension pMDI development programs. This line will manufacture pMDIs containing HFO-1234ze and HFA-152a propellants, enabling the production of 2.5 to 10-kilogram batches.
As the pharmaceutical industry seeks viable alternatives to comply with the phase-down, extensive research and development are required. The focus is on transitioning away from common HFA propellants like 134a and 227ea to low-GWP HFA and HFO propellants such as 152a and 1234ze—propellants accommodated by Oz-UK's new manufacturing line. These low-GWP alternatives have distinct physiochemical properties that can impact formulation stability and spray formation, necessitating significant R&D efforts to support the transition.
To keep up with global demand for R&D, formulation, and pilot production capabilities, Oz-UK is rapidly investing in its facilities. The company now offers formulation development services that include 10-liter mixing vessels and Pamasol suspension filling equipment. Notably, Oz-UK holds both a schedule 1 & 2 Controlled Drugs Licence, allowing for pMDI development work with a wide range of active pharmaceutical ingredients (APIs) within a regulated environment.
Pharmaceutical and cannabinoid companies engaged in R&D projects involving aerosol propellant replacement, formulation design, and IP submissions for inhalation can now manage their drug development projects in a fully outsourced environment at Oz-UK before scaling up to in-house manufacturing.
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