The pulmonary route is gaining increasing attraction not only for low-dose locally acting therapies, e.g. Asthma and COPD, but also for systemic applications often require higher doses or new formulation technologies. High-performance devices need to be developed to accommodate the requirements to deliver these new drugs/formulations efficiently. To ensure the best performance, the development of the formulation and the device should go hand in hand.
Dry Powder inhaler devices are used to deliver the medication in powder form to the lungs via oral inhalation. Medication in powder form can be filled in either a capsule, blister, reservoir or cartridge based on the drug product configuration. The device can be either an active or a passive device. In many cases, capsule-based inhalers are preferred solutions for new applications because they offer several interesting features, e.g. possibility to use a wide range of different APIs and doses generally ranging from 5 mg to 50 mg. Further advantages include ease of use and a good feedback mechanism for the patient.
Due to the complexity and cost of manufacturing multidose DPI devices, pharma companies want to minimise cost and risks in the new applications by using a simpler and more affordable device.
For some new applications, e.g. pain relievers or antibiotics, a reusable dose is beneficial; for others, e.g. vaccines, a disposable single-use is required. In both cases, capsule-based inhalers can be a good solution.
Covid 19 has made it imperative that an easy-to-use vaccine is available worldwide and remains stable at ambient conditions. Research continues to happen to deliver the vaccine by the inhalation route.
However, there are some drawbacks associated with current capsule-based DPI devices, e.g. Low performance is an inherent feature of many capsule-based DPI devices on the market. Even newly developed integrated solutions for antibiotics, e. g, Tobramycin, do not reach a higher FPF than 35%. In order to achieve the therapeutic dose of the antibiotic, the patient has to inhale 4 capsules a day.
Many of the strategies for overcoming the inherent challenges of most existing devices are done by focusing on improved dispersion properties of the formulations. Not a lot of attention was paid to improving the devices either by technological advancements of the device performance (higher deagglomeration and less retention of powder in the device/capsule) or on increasing patient adherence
for better handling and thus, higher deposition in the deep lungs.
The novel Presspart DPI device addresses the above problems and challenges of capsule-based inhalers. The most important features of an ideal capsule-based DPI device are, the ease of use with a good feedback mechanism to the patient coupled with a cost-effective design. In addition, dose delivery with high reliability and consistency, and high-performance efficiencies for a wide range of applications are desired.
