PureHale® Technology Platform
Multidose Systems, Bag-On-Valve
Pharma
Aptar Pharma’s PureHale® is a portable, ready-to-use, fine mist dispensing system that targets delivery to the upper airways. Natural saline mists can help to cleanse and moisturize the upper airways which may ease the symptoms caused by a variety of respiratory track conditions.
PureHale®´s continuous fine mist of saline or non-chemical formulations targets deposition to the mucosal tissues of the nose, nasal cavity, mouth and throat, where the symptoms of respiratory conditions such as coughs, colds, allergies, dry nose and throat, as well as other irritations can occur.
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PureHale® Reaches the Upper Airways the Gentle Way
Helping consumers care for their upper airways
Consumers are increasingly seeking ways to address upper airway symptoms in a more natural way. Saline solutions have been shown to help reduce or relieve symptoms caused by upper airway conditions such as colds and allergic rhinitis.
Our PureHale® fine mist dispensing technology offers an easy-to-use and convenient format to delivery non-chemical formulations of saline or other comparable solutions to the upper airways.
Fine mist technology with a purpose
PureHale®’s innovative technology distributes a continuous fine mist that targets droplet deposition in the upper airways. The soft mist deposits the formulation on the targeted mucosal tissue of the nose, nasal cavity, throat and mouth.
With mouthpiece and mask configurations available, PureHale® is a ready-to-use, on-the-go fine mist dispensing system, that’s so easy to use that its suitable administration to children and toddlers.
Growing demand for natural fine mist products
Consumers are seeking simple, non-invasive ways to deliver natural, non-chemical products to the upper airways. A number of studies have been conducted demonstrating the positive results of saline nasal products. Saline fine mists have been shown to be suitable to moisturize or sooth the upper respiratory tract of babies, toddlers and children.
The daily use of saline nasal sprays or drops was proven to provide some relief from nasal symptoms in children and adults suffering from respiratory tract infections or allergic rhinitis in a 2021 study Ref 1, with no side effects. Nasal saline sprays have also been added to some national guidance programs and further studies have concluded that the daily use of saline nasal sprays at the first sign of respiratory infection can contribute to shortening illness duration by as much as three days Ref 2.
PureHale® is a fine mist delivery solution expressly designed to deliver natural, non-chemical products, such as saline, to the upper airways in a convenient consumer friendly format.
PureHale® targets the Upper Airways
Aptar Pharma performed extensive testing to demonstrate that PureHale® technology could deliver saline formulations as a fine mist, targeting deposition in upper respiratory regions.
Tests included Next Generation Impactor (NGI) analysis to differentiate deposition levels between upper and lower airways and computational Fluid Particle Dynamics (CFPD) revealing detailed spatial and quantitative deposition patterns within the upper and lower airways.
Tested using both mask and mouthpiece configurations, PureHale® fine mist dispensing technology demonstrated an ability to target the desired regions of the upper airway without depositing to the lower airway or lungs. The comprehensive in-vitro and in-silico generated modelling data sets indicated that with appropriate breathing manouvres, the throat and nasal cavities can be reliably targeted using the PureHale® system Ref 3.
PureHale® targets the NALT region
Simulation data generated in conjunction with the University of Cyprus clearly shows that PureHale® fine mist dispensing systems provide broader coverage of the entire upper respiratory tract than nasal sprays, which concentrate their deposition in the nasal cavity.
An oral inhalation manouvre followed by a nasal exhalation, revealed in simulations, the ability to provide complimentary coverage of the nasopharynx-associated lymphoid tissue (NALT) region when using a PureHale® soft mist dispensing system.
The NALT region, located at the very rear of the nasal breathing channel plays a significant role in the development of mucosal immunity cells. Being able to deliver fine mist formulations to this region can provide improved mucociliary clearance, immunology or general nasal disinfection.
Modular platform for a diverse, highly efficient product portfolio
The PureHale® fine mist dispensing technology platform provides a variety of customizable product solutions, including a range of container sizes, and interchangeable mask and mouthpiece configurations. These options provide product companies with a diverse range of unique soft mist delivery options, that can expand brand and product differentiation. Aptar Pharma’s global reach and specialized fine mist dispensing technology, PureHale® can help customers extend their product ranges and offer distribution beyond existing sales channels.
PureHale® utilizes well established Bag-On-Valve (BOV) filling processes that are commonly used across the industry. With minimal parameter changes, pre-existing filling lines can be easily adapted to accommodate PureHale® BOV filling.
PureHale® Technology Platform Advantages
Targets Upper Airways
Gentle mist for upper airways
PureHale®’s fine mist is designed to specifically target delivery to the upper airways. Producing a continuous fine mist with a droplet size of approximately 15 µm to 20 µm, PureHale® is optimized for deposition to the upper respiratory tract. PureHale® emits a fine mist at a rate of approximately 1 ml of formulation per minute.
Easy-to-Use
Portable, gentle and silent
PureHale®’s user-friendly system features an easy on-off activating ring mechanism.
By turning the actuator, the valve opens and the pressure between the can and the bag presses the formulation out in the form of a continuous fine mist. It’s ready to use and no prefilling of a reservoir is required.
Upper Respiratory Care
A new way to provide upper respiratory care
Nasal saline fine mists can cleanse and moisturize the upper airway tissues, supporting improved nasal hygiene. PureHale® offers parents a new non-invasive way to deliver saline soft mists to babies and toddlers in a gentle way.
Flexible Delivery
One product – multiple options
With provided mouth piece and face mask accessories, PureHale® gives users flexibility. With different breathing manouvres, PureHale® can target mist delivery to specific regions of the upper airways. Nasal breathing manouvres can reach the nasal cavity and throat, while an oral breathing manouvre can target significant deposition in primarily the throat. Combined oral-nasal breathing manouvres can be used to target the nasal-associated lymphoid tissue (NALT) region using PureHale®’s fine mist dispensing technology.
Portable & Ready-to-Use
Power-free for on-the-go usage
PureHale® does not require a battery power source making it a purely mechanical (non-electric) fine mist delivery system. It’s ideal for convenient, on-the-go dispensing.
Silent Delivery
Discreet delivery for application anywhere
PureHale®’s lightweight, easily transported format offers quiet dispensing of fine mists for discrete use virtually anywhere. Ideal for home, work or when travelling.
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References
1 The Role of Saline Nasal Sprays or Drops in Nasal Hygiene: A Review of the Evidence and Clinical Perspectives, E. Santoro, P. Kalita, P. Novak, Rhinology Online, Volume 4: 1-16, 2021, https://www.rhinologyonline.org/Rhinology_online_issues/manuscript_102.pdf
2 Nasal Sprays and Behavioural Interventions Compared with Usual Care For Acute Respiratory Illness In Primary Care: A Randomised, Controlled, Open-Label, Parallel-Group Trial, Paul Little, Jane Vennik, Kate Rumsby, Beth Stuart, Taeko Becque, Michael Moore, Nick Francis, Alastair D Hay, Theo Verheij, Katherine Bradbury, Kate Greenwell, Laura Dennison, Sian Holt, James Denison-Day, Ben Ainsworth, James Raftery, Tammy Thomas, Christopher C Butler, Samantha Richards-Hall, Deb Smith, Hazel Patel, Samantha Williams, Jane Barnett, Karen Middleton, Sascha Miller, Sophie Johnson, Jacqui Nuttall, Fran Webley, Tracey Sach, Lucy Yardley, Adam W A Geraghty, Lancet Respir Med 2024, Published Online, July 11, 2024 https://doi.org/10.1016/ S2213-2600(24)00140-1
3 Aerosol Deposition Characterization of Innovative PureHale® Technology Targeting the Upper Airways, D. Marx, F. Stylianou, S. Kossinos, Drug Development & Delivery, September 2021, volume 21, Number 6. https://drug-dev.com/delivery-device-aerosol-deposition-characterization-of-innovative-purehale-technology-targeting-the-upper-airways/
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