Clickhaler® dry powder inhaler: focussed in vitro proof of principle evaluation of a new chemical entity for asthma

A new chemical entity (NCE) was evaluated in the Clickhaler® (Innovata Biomed Ltd.) dry powder inhaler, a reservoir-based multidose delivery system. The standard device metering system was modified to handle higher doses (nominally 20 mm 3 of lactose based blend). The micronized drug was formulated...

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Bibliographic Details
Published in:International journal of pharmaceutics 2002-06, Vol.239 (1), p.149-156
Main Authors: Thibert, Roch, Parry-Billings, Mark, Shott, Martin
Format: Article
Language:English
Subjects:
Aerosol
Anti-Asthmatic Agents - administration & dosage
Asthma
Biological and medical sciences
Drug Storage
Dry powder inhaler
General pharmacology
Humidity
Medical sciences
Nebulizers and Vaporizers
Particle Size
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Powders
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Summary:A new chemical entity (NCE) was evaluated in the Clickhaler® (Innovata Biomed Ltd.) dry powder inhaler, a reservoir-based multidose delivery system. The standard device metering system was modified to handle higher doses (nominally 20 mm 3 of lactose based blend). The micronized drug was formulated at 12.5% w/w in lactose monohydrate (Pharmatose 325M, DMV) equivalent to a nominal dose of approximately 1 mg. Delivered shot weight (mg of blend) and emitted dose (μg drug) averaged 7.4 mg and 905 μg, respectively, and were consistent (within ±20 to 25% of mean) through the life of the inhaler. The fine particle fraction (FPF) (Andersen cascade impactor) was typically 60%. A short stability study (i.e. 3 months at room temperature, 53 or 75% RH, unpacked) showed that the in vitro performance was maintained. The results of these studies provide in vitro proof of principle for this novel drug/device combination.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(02)00106-0