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Design, development and performance of a novel multidose dry-powder inhaler
M Parry-Billings1, R N Boyes, L M Clisby
1R&D at Innovata Biomed Ltd, Respiratory Division of ML Laboratories plc, St Albans, UK. mparryb@aol.com
Medical Device Technology
|March 21, 2000
Summary
A new breath-actuated multidose dry-powder inhaler demonstrates robust performance. Clinical studies show asthma medications delivered via this device are as effective and safe as traditional inhalers.
Area of Science:
- Pharmaceutical technology
- Respiratory medicine
- Medical device engineering
Background:
- Pressurized metered-dose inhalers (pMDIs) and existing dry-powder inhalers (DPIs) are standard for respiratory disease treatment.
- There is a continuous need for improved inhaler devices offering enhanced usability and consistent drug delivery.
Purpose of the Study:
- To design and develop a novel breath-actuated multidose dry-powder inhaler (DPI).
- To evaluate the in vitro and in vivo performance and robustness of the developed DPI.
- To compare the clinical efficacy and safety of the DPI with standard inhaler devices.
Main Methods:
- Device design and fabrication of a breath-actuated multidose DPI.
- In vitro aerodynamic particle size distribution and dose uniformity testing.
- In vivo pharmacokinetic and clinical efficacy studies in patients with asthma.
Main Results:
- The developed DPI demonstrated consistent dose delivery and robust performance across various conditions.
- In vitro tests confirmed acceptable aerodynamic properties for efficient lung deposition.
- Clinical studies showed budesonide, beclomethasone dipropionate, and salbutamol delivered via the DPI had comparable efficacy and safety profiles to pMDIs and other DPIs.
Conclusions:
- The novel breath-actuated multidose DPI is a viable alternative for delivering respiratory medications.
- The device offers comparable clinical performance and safety to existing inhaler technologies.
- This innovation holds potential for improving patient adherence and treatment outcomes in asthma management.
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