The Novolizer: a multidose dry powder inhaler

Area of Science:

• Respiratory Medicine
• Pharmacology
• Biomedical Engineering

Background:

• The Novolizer is a multidose, refillable, breath-actuated dry powder inhaler.
• It features a multiple-feedback control mechanism for inhalation assurance.

Purpose of the Study:

• To evaluate the performance, efficacy, and safety of the Novolizer dry powder inhaler.
• To compare its peak inspiratory flow rates (PIFRs) and drug delivery with other inhaler devices.

Main Methods:

• Randomized studies assessed patient ability to achieve sufficient PIFRs.
• Comparative studies evaluated PIFRs against Turbuhaler.
• Drug deposition studies in healthy volunteers.
• Randomized, double-blind trials in asthma patients compared efficacy.
• Nonblind study compared budesonide delivery in COPD/asthma patients.

Main Results:

• Most patients, including children and first-time users, achieved adequate PIFRs with the Novolizer.
• Significantly higher PIFRs were generated with Novolizer compared to Turbuhaler.
• Median lung deposition of budesonide ranged from 19.9-32.1% at specific PIFRs.
• Clinical efficacy was comparable to Aerolizer and Sultanol.
• Therapeutic equivalence was shown with Turbuhaler for budesonide delivery.
• No device-related adverse events reported in trials or post-marketing surveillance (n>3000).
• 80% of patients showed improved compliance due to device control mechanisms.

Conclusions:

• The Novolizer is an effective and well-accepted dry powder inhaler for delivering medications.
• Its design supports adequate inhalation technique and drug delivery for asthma and COPD management.
• The device demonstrates comparable clinical efficacy and safety to other leading inhalers.