Delivery of salbutamol and of budesonide from a novel multi-dose inhaler Airmax.
A novel multi-dose inhaler has been developed to closely approach the characteristics of an "ideal" inhaler. The new device, Airmax, uses proprietary technologies known as the X-ACT system to provide accurate and consistent dosing and excellent lung deposition--even at low inspiratory flow rates--combined with ease of use by the patient. Dose delivery was close to label claim, with relative standard deviation of typically around 5% for through-life emitted mass and around 10% for dose per actuation. At a flow rate (60-70 l/min), which corresponds to 4 kPa pressure drop across the device, the mean fine particle (<5 microm) dose (FPD) from 100, 200 and 400 microg strength budesonide Airmax was around 46, 98 and 244 microg, respectively. The mean FPD from 100 microg strength salbutamol Airmax was approximately 50 microg at the same flow rate. At 30 l/min, the delivered dose from Airmax is over 85% label claim with fine particle fraction of over 35%. Performance was unaffected by shaking or orientation, provided the device was not used completely upside down, and priming was not required. There was no change in dose content uniformity and aerodynamic particle-size distribution after the devices have been stored unwrapped at 30 degrees C/60% RH up to 24 months. Airmax is robust, portable and intuitive to use.
IVAX Pharmaceutical UK Ltd, Royal Docks, London. xian-ming.zeng@ivax.co.uk
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Zeng
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O'Leary
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Phelan
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Jones
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Colledge
D000280:Administration, Inhalation; D000420:Albuterol / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D019819:Budesonide / Q000008:administration & dosage*; D004867:Equipment Design; D006801:Humans; D008171:Lung Diseases / Q000188:drug therapy; D009330:Nebulizers and Vaporizers / Q000592:standards*; D010316:Particle Size; D011208:Powders
D001993:Bronchodilator Agents; D011208:Powders; D019819:Budesonide; D000420:Albuterol