Aptar Pharma has announced that it will officially launch its new PureHale aerosol device at CPhI Worldwide. Purehale, a bag-on-valve “nebulizer-like device,” is a finalist for the CPhI Pharma Awards in the drug delivery device category.
Although the blurb for PureHale on the CPhI page says, “Delivering portable respiratory relief, revolutionizing the nebulizer market” and the press release claims the device is designed to overcome the challenges of “traditional nebulizers,” an Aptar Pharma spokesperson clarified to OINDPnews that, “PureHale is designed to deliver commonly used saline solutions, enriched saline solutions and other natural ingredient formulations like eucalyptus, menthol, mint, etc,” and the device is meant for the over-the-counter market.
According to an Aptar Pharma press release, “PureHale’s innovative technology distributes a continuous fine mist that gently cleanses, moisturizes and soothes the upper respiratory tract, in turn helping to reduce irritations caused by coughs, colds, allergies, respiratory problems and dry nose/throat issues.”
Aptar has specified that the PureHale produces particles in the 20-30μm range and that depending on the size of the container, it would have the capacity to produce a mist for 30-90 minutes, although it is intended for shorter usage times.
The company said that no clinical trials or regulatory reviews have been undertaken to date.
Aptar Pharma Consumer Healthcare Division President Thomas Klofac said, “PureHale enables pharmaceutical partners to expand their audience reach for their brand formulations, providing portable, symptomatic relief for upper respiratory system conditions. PureHale provides brand differentiation via a range of personalization options and, with minimal parameter changes, existing filling processes can be easily adapted to fill PureHale. Aptar Pharma has extensive regulatory experience and this, combined with several standardized solutions, can satisfy a rapid-to-market launch objective.”
Read the Aptar Pharma press release.
