Aptar said that the company has won a contract worth up to $6 million from the FDA for a study “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.” According to Aptar, the study is part of the FDA’s development of guidance for development of metered dose inhalers with low global warming potential (LGWP) propellants. The work will be performed by Aptar subsidiary Nanopharm, the company said.
Aptar Pharma VP Analytical Regulatory and Scientific Affairs Guillaume Brouet commented, “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.”
Read the Aptar Pharma press release.
