The K-Haler® exemplifies how we innovate in drug delivery and take this innovation into production.
Taking Clinical Designs’ original concept for the valve, TTP initially demonstrated a successful manufacturing solution for the technology. We then developed a full pMDI device around this valve and took this design through to pilot production. The result is a 6-part breath-actuated inhaler (BAI) instead of a more typical 14- or 15-part BAI.
The device has a low fire point for easy actuation, and a very low step change in pressure drop. This gives a nice 'feel', increasing patient acceptability as does its small size and ease of use (open – inhale – close). It also achieves excellent in-vitro equivalence.
The K-Haler is a unique, pressurised metered-dose inhaler (pMDI) which uses an innovative kink valve to create a breath-actuated delivery mechanism. Breath-actuated devices are typically expensive and complex with many components. The novel kink valve in our design enabled a much simpler design and lowered the cost to manufacture.