Kolibri™: Precision Inhalation for Biologics with Guided Breathing

Kolibri™ Mesh Nebuliser: Revolutionizing Pulmonary Biologic Delivery

The Kolibri™ Mesh Nebuliser, developed by PULMOTREE and commercialized in collaboration with Aptar Pharma, addresses the significant challenges of respiratory delivery of biologics with its guided inhalation system, integrating an innovative feedback mechanism that optimizes aerosol performance, minimizes variability in patient breathing patterns, and ensures precise drug deposition. Efficient and reproducible drug deposition in targeted lung regions is crucial for maximizing therapeutic effects while minimizing drug losses, especially given the high cost and complex formulations of biologics.

Guided Breathing Technology

One of the primary factors influencing the efficacy of pulmonary drug delivery is the patient’s breathing maneuver, which can vary significantly. Kolibri™ integrates a guided inhalation system with haptic feedback to support and guide the patient’s inhalation, ensuring an optimal breathing pattern throughout the nebulized treatment. This innovative feedback mechanism optimizes aerosol performance, minimizes variability in patient breathing patterns, and ensures precise drug deposition. This haptic feedback works by guiding users to maintain an ideal inhaled flow rate, providing a pleasant positive vibration when inhalation remains within a predefined optimal range. Conversely, if the inhalation flow rate exceeds this limit, the system provides a discouraging negative vibration to prompt adjustment.

Realistic Breathing Profiles

Kolibri™ uses realistic breathing profiles in in vitro and in silico testing to enhance the predictive accuracy of aerosol drug delivery systems. By incorporating patient-specific breathing profiles and lung geometries, Kolibri™ enables more precise simulations of regional lung deposition, optimizing drug formulation and device matching. By leveraging realistic inhalation data during early development phases, pharmaceutical companies can improve the predictive power of their studies, ensuring a better match with real-world performance. This approach helps mitigate risks in drug-device development, reducing costly late-stage failures and streamlining regulatory approval processes.

Collaborative Case Study: Optimizing Aerosol Deposition

In the context of the Kolibri-OCK4 combination product development, PULMOTREE aimed to assess the impact of the Kolibri guided breathing profile on the deposition of OCK4 through advanced in silico simulations. The Kolibri™ platform was tailored specifically for OCK4, a heparin derivative developed to target the small airways and alveolar lung regions. Advanced in silico simulations demonstrated that the Kolibri™ guided breathing profile resulted in higher deposition in target regions compared to spontaneous unguided breathing profiles.

The Power of Collaboration

The current synergy between PULMOTREE and Aptar Pharma enables seamless integration of cutting-edge nebuliser technology with realistic breathing profiles, providing a comprehensive approach to aerosol characterization. This collaboration offers multiple advantages for partners, including risk reduction in clinical development by providing access to realistic and representative data from in vitro and in silico testing, optimized drug-nebulizer matching and tailoring, ensuring safer and better therapeutic outcomes, and regulatory advantages, including realistic data that can improve in vitro/in vivo correlation, supporting regulatory submissions.

Conclusion: A Step Forward for Nebulised Biologics

Kolibri™ is transforming the respiratory delivery of biologics by combining PULMOTREE’s guided inhalation technology with Aptar Pharma’s industry expertise, enabling more precise, patient-adapted drug delivery solutions. The integration of real patient data into drug development enables improved nebuliser performance, optimized aerosol deposition, and enhanced clinical outcomes. As the industry moves toward more efficient and personalized drug-device combination products in respiratory drug delivery, PULMOTREE and Aptar Pharma stand at the forefront of this transformation.