In Context
Triple therapy inhalers combine the necessary antiinflammation and bronchodilator medications in a single product. This combination is designed to help manage chronic obstructive pulmonary disease (COPD) and asthma with a once-daily regimen, simplifying treatment and improving adherence.
Several pharmaceutical companies are poised to launch complex generics of the Ellipta product range by GlaxoSmithKline (GSK). Some generic competitors will likely employ alternative technologies from companies like Coalesce, Merxin, Vectura, TTP or Berry.
The Challenge
Matching the performance of a reference inhaled drug-device combination product without replicating the core aerosolization physics can prove unfeasible. The lack of regulatory submissions for generic competitors across a range of inhaled therapies supports this difficulty.
Perdigó has set out to offer pharmaceutical companies a de-risked development programme for inhaled complex generics of products like Ellipta. Perdigó’s Xaloc device will match the design of Reference Listed Drug (RLD) aerosol engine, significantly reducing technical risk.
Perdigó's Approach
Dual-strip inhalers typically involve 25-30 components, making robust mechanical design a crucial aspect of device production scale up. This is one of the key strengths of the medical device design work by Perdigó, which involves:
- Tolerance analyses
- Prototyping
- Design for Manufacturing and Assembly (DfMA)
- Device Failure Modes and Effects Analysis (FMEA)
- Device Verification
- Testing (DVT)
- Design Reviews
In Barcelona, “Xaloc” is a southeastern wind that typically carries fine sand from the Sahara desert. The low Stokes number of this Mediterranean dry powder airflow inspired the naming of Perdigó’s dry powder inhaler.
The IP landscape for dual-strip Dry Powder Inhalers is complex, but successful device IP strategies remain available to pharmaceutical companies pursuing this product. Similarly, the Industrial Design of Xaloc is still open to adapt to the design language of its manufacturer. While matching product performance and user sequence of use limits certain aspects of the design, the final product will have distinctive character.
Perdigó has extensive experience in achieving aerosol performance match with respect to an RLD such as Trellegy Ellipta (GSK). Metrics of reference include the NGI profile, several definitions of FPF including ISM, and delivered dose, which may be tested at different airflow rates. We further assess metrics from non-analyical test methods such as delivered mass and PSD.
Human Factors play an integral role in combination product development. For directly substitutable generics (FDA 505j submission route), it is important to show equivalence of the sequence of use, in addition to good usability through the product lifecycle.
Delivered Value
Xaloc is a Dry Powder Inhaler (DPI) platform device, available for pharmaceutical companies to develop double and triple therapy combination products.
Perdigó’s experience and preparation mean that fully functional prototype devices can be readied in less than one year, with low technical risk.
