An Insight Into the Aerosolization Pattern of Formoterol Fumarate Dry Powder Inhalation Formulation Actuated Via Two...

Area of Science:

• Pharmaceutical Sciences
• Respiratory Medicine
• Biomedical Engineering

Background:

• Effective inhaled drug delivery is crucial for managing respiratory conditions like bronchial asthma and chronic obstructive pulmonary disease (COPD).
• Dry powder inhalers (DPIs) are widely used for delivering inhaled medications, but their performance can vary significantly based on device design.
• Formoterol fumarate is a common long-acting beta-agonist used in the management of asthma and COPD.

Purpose of the Study:

• To compare the aerosolization efficiency of two different DPIs, the Aerolizer and Revolizer.
• To evaluate the performance of these devices using a fixed formulation of formoterol fumarate.
• To determine the impact of inhaler design on drug delivery metrics.

Main Methods:

• Aerodynamic particle size distribution was measured using a next-generation impactor (NGI).
• Delivered dose uniformity was assessed using a dosage unit sampling apparatus (DUSA) at a fixed flow rate (60 L/min).
• Drug content was quantified via high-performance liquid chromatography (HPLC), with data analyzed using CITDAS software and statistical tests.

Main Results:

• The Aerolizer achieved a significantly higher fine particle dose (FPD) (4.71 µg) compared to the Revolizer (1.97 µg), approximately 2.39 times greater.
• The Aerolizer delivered a greater overall dose (approx. 20% higher) and exhibited more consistent deposition across NGI stages.
• While fine particle fractions (FPFs) were similar, the superior FPD from the Aerolizer was attributed to its higher emitted dose.

Conclusions:

• Inhaler device design substantially influences DPI performance, even with a constant drug formulation.
• The Aerolizer, characterized as a low-resistance inhaler, demonstrated superior drug delivery efficiency compared to the Revolizer under standardized testing conditions.
• Further research incorporating pressure-drop-adjusted or patient-simulated inhalation profiles is recommended to better reflect clinical scenarios and understand device mechanics' role in drug delivery.