CRYSTAL LAKE, Ill.– AptarGroup, Inc. (NYSE: ATR), a global leader in drug and consumer product dosing, dispensing and protection technologies, is announcing a contract with the U.S. Food and Drug Administration (FDA) to study the challenges with developing low Global Warming Potential (low-GWP) propellant metered dose inhalers (MDIs).
Moreover, Aptar’s study will help to define the potential target product profile of low-GWP propellant MDIs to achieve comparability in critical quality attributes (CQAs) to existing MDIs.
With this study, Aptar will support the FDA with its industry-leading research and development center and respiratory team, which is enhanced by state-of-the-art technologies and the know-how to develop complex orally inhaled and nasal drug products (OINDP). Additional capabilities Aptar can provide include pilot manufacturing / process, analytical methods offering alternative pathways to clinical trials, formulation development, metering valve technology and more.
The result of Aptar’s study is designed to provide the FDA with information related to the formulation, manufacture, device design and quality aspects related to low-GWP propellant MDIs and their utility to replace existing propellant MDIs. Moreover, the study is expected to support the ongoing FDA efforts to provide guidance on the regulatory framework with respect to the evaluation and approval of low-GWP propellant MDIs. The results of the study will be reviewed and discussed with the agency as detailed case studies, which can then be published as scientific publications and conference presentations.
Guillaume Brouet, VP of Aptar Pharma Analytical Regulatory and Scientific Affairs, said, “Our leading OINDP research company, Nanopharm, alongside with our Pharma segment’s research and development team, is delighted to support the FDA on this important study to better define the design space for developing low-GWP MDIs with equivalent performance to existing propellant MDIs.”
The contracted work, including “optional contract line items”, is valued at up to approximately $6 million.
