The DirectHaler™ Pulmonary device platform has minimum component complexity, which allows wide freedom in creating device customisation options. Customizations and new device versions are developed for:

• Sensitive powders
• Deep lung delivery
• High drug payloads
• New types of combination dosing

Protection of sensitive powders
Active substances and their formulations often have variable sensitivities to moisture, light, and mechanical impact. The DirectHaler™ devices can accommodate such needs for protection. The powder dose is sealed inside the cap with a laminate foil strip, which is easily torn off for dose-loading into the PowderWhirl chamber, before removing the cap and delivering the dose. Some therapeutic applications require delivery of two doses. DirectHaler™ Pulmonary can be supplied with caps for bi-dose storage and dose-encapsulation, along with customised device appearance; both designed for optimal ease of use.

Two new device prototypes for demanding delivery tasks
The increasing number of new powder formulation technologies enable formulation of porous powder particles with high aerodynamic diameter, manufactured with an attractive narrow size distribution. Such powders are together with optimized yet simple DPI devices, expected to challenge the use of complex and expensive pulmonary devices for systemic inhaled delivery tasks. DirectHaler™ Pulmonary is a strong platform for creating such optimized next generation devices.

Two prototypes have been created to optimize the DirectHaler™ Pulmonary for deep lung delivery of such new types of powder formulations. Contact us for revealing the two new prototypes within the two hands.

Building combination doses
The DirectHaler™ Pulmonary device can be considered as the basic building block in any combination therapy or dosing sequencing involving pulmonary delivery. This means that the DirectHaler™  Pulmonary device could be the pulmonary component in a combination therapy consisting of, for instance: one pulmonary dose + one oral dose in the same blister pack.

Such innovative combination therapy options, using two delivery routes at the same time, would enable the design of delivery systems that would, for example, achieve:

• Local action (pulmonary) + systemic action (oral);
• Rapid onset of action (pulmonary) + delayed and sustained release (oral).

Targeting the complete respiratory system
Dosing to the complete respiratory system has previously only been possible by special nebulisers with facemasks and limited portability. The DirectHaler™ technologies do away with these limitations, opening a completely new option for drug delivery to the whole respiratory system with its dry powder formulations.

DirectHaler™ Pulmonary and DirectHaler™ Nasal are the first unit-dose devices that can be clicked together as one device, enabling specific dosing to the nasal and pulmonary airways, thereby targeting the complete airway system. Such targeting can be highly relevant in treatment of respiratory diseases, and in the prevention/treatment of respiratory infections (also in relation to biodefence).

Pulmonary combination dosing
DirectHaler™ Pulmonary offers a new option for establishing a pulmonary combination therapy:

Two DirectHaler™ Pulmonary devices can be “clicked” together; constituting a “compliance-dose” built of two separate (complete) devices each containing one drug dose. Together the devices represent a novel combination dose administration form.

• Each of these “combination-dose”-sets can be conveniently packed in tamper proof pharma-blister packs.
• Each dose of active substance is kept separately - enabling individual formulation approach and storage for each dose.

Customized dose sequencing
DirectHaler™ Pulmonary can be pre-packed in a specific therapeutic dosing sequence for a specific period. The pharma-blister packing allows to align and fix a certain dosing sequence in a strip of devices with pre-filled doses.

On the picture is shown an example of for a six-days  therapy pulmonary dosing schedule, with specific dosing strength for day 1, 2 and 3 (blue, green and yellow). The colour coding ensures clear marking of dosing strength. The sequence of three is repeated for days 4, 5 and 6.