Versatility of Softgel Technology – Encapsulation of a Volatile Compound

Xhale, Inc., a commercial stage medical technology company, had developed the SMART Medication Adherence Monitoring System technology to non-invasively monitor adherence to oral medications. The system is based on detecting 2-butanol, a metabolite of the adherence marker, in patients’ breath and therefore can be used to definitively verify, monitor, and report how and when study participants are taking their medication in real time. By working with Catalent Pharma Solutions, Xhale, Inc. has developed SMART Softgels featuring a special shell to release quickly while still preventing evaporative loss during and after manufacturing

• Challenges that Xhale faced when trying to overcome their molecule’s physiochemical properties, such as low flash point, high volatility, low viscosity, and evaporative loss during and after manufacturing.
• The team maintained high 2-butanol loading and proper capsule properties (%LC, hardness, and moisture).
• Optimization of manufacturing parameters such as lower processing temperature and thinner softgel shell.

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