title: Clickhaler dry powder inhaler: focussed in vitro proof of principle evaluation of a new chemical entity for asthma.
abstract: 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 (microg drug) averaged 7.4 mg and 905 microg, 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.
authors.affiliation: Merck Frosst Canada & Co., Pharmaceutical R&D, PO Box 1005, Dorval, Quebec, Canada H9R 4P8.
authors.forename: Roch
authors.initials: R
authors.lastname: Thibert
authors.forename: Mark
authors.initials: M
authors.lastname: Parry-Billings
authors.forename: Martin
authors.initials: M
authors.lastname: Shott
mesh_terms: D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D004356:Drug Storage; D006813:Humidity; D009330:Nebulizers and Vaporizers; D010316:Particle Size; D011208:Powders
chemical_list: D018927:Anti-Asthmatic Agents; D011208:Powders