Aptar Pharma announced today that it entered into a contract with the FDA to work on low global warming potential (low-GWP) inhalers.
The FDA enlisted Aptar to study the challenges of developing low-GWP propellant metered dose inhalers (MDIs). The Crystal Lake, Illinois-based company expects its study to help define the potential target product profile of low-GWP propellant MDIs. It hopes to achieve comparability in critical quality attributes to existing MDIs.
Aptar values the contracted work, which includes “optional contract line items,” at approximately $6 million.
Within the work, the company will support the FDA with its R&D center and respiratory team. It offers state-of-the-art technologies and know-how for developing complex orally inhaled and nasal drug products (OINDP). Aptar can also offer pilot manufacturing/process, analytical methods for clinical trials, formulation development, metering valve technology and more.
Aptar expects to provide the FDA with information related to low-GWP propellant MDIs and their utility to replace existing MDIs. Details include information related to the formulation, manufacture, device design and quality aspects. Additionally, the company expects the study to support ongoing FDA efforts to provide guidance on regulatory framework.
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.”