Delivery of formoterol from a novel multi-dose inhaler Airmax.
Using a proprietary technology known as the X-ACT system--Active-metering, Cyclone-separator Technology, a novel multi-dose inhaler (Airmax) was developed to provide accurate and consistent dosing and a high-fine particle fraction ofthe drug. Formoterol, present as a blend with lactose monohydrate was delivered from Airmax to obtain a nominal formoterol dose of 6 or 12 microg. The devices were tested using a five-stage liquid impinger and a unit dose sampling apparatus, operated under conditions specified in European Pharmacopoeia (2000). Fine-particle dose (FPD) was defined as the dose of the aerosolized drug particles with an aerodynamic diameter < 5 microm and fine particle fraction (FPF) was the ratio of FPD to the total recovered dose. Dose per actuation was found to be 97.0+/-11.5% label claim (LC) or 5.8+/-0.7 microg (n = 140), and 100+/-9.4% LC or 12+/-1.1 microg (n=440), for the 6 and 12 microg strengths, respectively. The mass median aerodynamic diameter was 2.4+/-0.1 microm (n = 14), the geometric standard deviation 2.1+/-0.1 (n = 14), and FPF 44.4+/-24% (n= 14) for both strengths. Thus, the combination of active metering and cyclone separator produces highly consistent doses of formoterol that have a large respirable fraction.
IVAX Pharmaceutical UK Ltd, Royal Docks, London. xian-ming.zeng@ivax.co.uk
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Zeng
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Jones
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O'Leary
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Phelan
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Colledge
D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D004867:Equipment Design; D004983:Ethanolamines / Q000008:administration & dosage*; D000068759:Formoterol Fumarate; D006801:Humans; D008171:Lung Diseases / Q000188:drug therapy; D009330:Nebulizers and Vaporizers / Q000592:standards*; D010316:Particle Size; D011208:Powders
D001993:Bronchodilator Agents; D004983:Ethanolamines; D011208:Powders; D000068759:Formoterol Fumarate