Scintigraphic evaluation of lung deposition with a novel inhaler device.
A gamma-scintigraphic study was carried out in 13 healthy individuals to compare the lung deposition of budesonide from a novel multidose dry powder inhaler (MDPI; Novolizer) with that from the Pulmicort Turbuhaler, and to assess the degree of flow rate dependence of the Novolizer. Median whole lung depositions for the Novolizer at peak inhaled flow rates of 90, 60 and 45 l/min were 32.0, 25.4 and 19.9% of the metered dose, respectively, compared with 21.4% for the Turbuhaler (peak inhaled flow rate 60 l/min). Patterns of regional lung deposition were similar for all four regimens. These data provided proof of concept in vivo for the novel MDPI device, and demonstrated that it delivers drug to the lungs efficiently. The deposition data enabled drug doses to be used in subsequent clinical trials comparing the Novolizer with the Turbuhaler to be predicted with confidence.
Newman
S P
SP
Pharmaceutical Profiles Ltd, Mere Way, Ruddington Fields, Ruddington, Nottingham NG11 6JS, UK. snewman@pharmprofiles.co.uk
Hirst
P H
PH
Pitcairn
G R
GR
D000293:Adolescent; D000328:Adult; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000493:pharmacokinetics; D019819:Budesonide / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D006801:Humans; D008168:Lung / Q000000981:diagnostic imaging* / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D011877:Radionuclide Imaging; D018709:Statistics, Nonparametric
D001993:Bronchodilator Agents; D019819:Budesonide