Xhale’s SMART® Adherence Technology Enabled Through Collaboration with Catalent

Xhale announces availability of first solution to enable integration of breath-detectable adherence markers into pharmaceutical products

Xhale, Inc., a commercial stage medical technology company focused on developing and selling patient-centric monitoring solutions for the healthcare industry, announced today the availability of SMART™ Softgels for clinical research use with the SMART® Adherence System. The breath-based SMART® Adherence System is being developed to verify, monitor, and report information about how and when study participants are taking study medications in clinical trials.

SMART™ Softgels are the first solution offered by Xhale to enable integration of breath-detectable adherence markers into a broad range of pharmaceutical products. SMART™ Softgels were designed, developed, and manufactured through a collaboration between Xhale and Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products.

Catalent and Xhale jointly presented scientific information about the development and performance of the SMART™ Softgels at the annual American Association of Pharmaceutical Scientists (AAPS) Meeting, the world’s largest gathering of pharmaceutical scientists. The SMART™ Softgels demonstrated stability, reliable release of the adherence marker, and favorable properties to support pharmaceutical use.

The SMART® Adherence System is designed to offer definitive and noninvasive monitoring of medication adherence, utilizing exhaled breath to confirm that medication has been taken by study participants as directed. Through near real-time reporting of reliable adherence information and a user-friendly breath analysis device, the SMART® Adherence System offers significant potential to optimize clinical trial management and outcomes.

Xhale chose to partner with Catalent because of its experience and track record of RP Scherer Softgel innovation, which spans more than 80 years. Working with Xhale, a Catalent RP Scherer Softgel product was developed to feature a thin shell to help overcome potential formulation challenges and prevent evaporative loss during and after manufacturing.

The SMART® Adherence System, including the SMART™ Softgels manufactured by Catalent, is now available for research use in the collection and reporting of definitive treatment adherence data in clinical studies. Xhale has filed a Type IV (Excipient) Drug Master File with the Food and Drug Administration (FDA) that contains comprehensive information supporting the use of SMART™ Softgels in clinical studies.

For more information about the SMART® Adherence System or SMART™ Softgels, please contact Xhale at info@xhale.com or 352-371-8488.

  

About Xhale

 Xhale, Inc. is a medical technology company developing and commercializing patient-centric monitoring solutions for the healthcare industry. Xhale is focused on developing two broad technology platforms. Through its Xhale Smart, Inc. subsidiary, Xhale is developing a medication adherence monitoring technology – the SMART® Adherence System – designed to verify, monitor, report, and improve adherence to medication regimens in clinical trials. The SMART® Adherence System is the only technology designed to offer definitive and noninvasive monitoring of medication adherence in near real-time, utilizing exhaled breath to confirm that medication has been taken as directed. Through its Xhale Assurance, Inc. subsidiary, Xhale is developing a patient monitoring technology, the Assurance® platform, designed to improve and expand the use of conventional pulse oximetry used in hospitals and other clinical settings to monitor critical patient parameters, as well as to increase the number of parameters which can be measured. Xhale’s first product based on this technology, the Assurance® Alar One-Sense™ pulse oximetry sensor, received marketing clearance in the United States. The Assurance® Alar One-Sense™ pulse oximetry sensor is a disposable sensor placed on a patient’s nasal ala which transmits heart rate and blood oxygenation information to an oximetry monitor.

Xhale, Inc. was founded in 2005 on technology licensed from the University of Florida.

For more information, please visit www.xhale.com or contact the company at info@xhale.com or 352-371-8488.

 

 About Catalent

Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com.

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