Abstract
Pulmonary deposition of 99mTc-labelled sulbutamol was determined after delivery from a novel multiple dose powder inhaler (Easyhaler®). The clinical efficacy of the inhalation powder, evaluated simultaneously with gamma camera detection, was compared with that obtained after drug delivery from a metered dose inhaler-spacer combination. The study was performed as an open, non-randomized cross-over trial. A single dose of radiolabelled inhalation powder was inhaled on the first and the inhalation aerosol, as control, on the second study day. Sulbutamol sulphate was labelled with 99mtechnetium, and the inhalation powder was formulated by mixing radioactive drug particles with carrier material. Aerodynamic properties of the radiolabelled inhalation powder were similar to those of the unlabelled salbutamol powder. Delivered dose from the breath-actuated powder inhaler was adjusted to be equal to two puffs from a conventional aerosol actuator with a short plastic mouthpiece. Twelve non-smoking asthmatic patients participated in the trial. The mean pulmonary deposition of 24% was obtained after drug delivery from Easyhaler® powder inhaler. Clinical efficacy of the medications was similar in terms of area under the FEV1 curve, maximum FEV1 and the improvement ratio. Thus it can be suggested that powder delivery from Easyhaler® powder inhaler and the aerosol delivery through the spacer are equally effective.
Similar content being viewed by others
REFERENCES
A. Anani, A. J. Higgins, and G. K. Crompton. Breath-actuated inhalers: Comparison of terbutaline Turbohaler with salbutamol Rotahaler. Eur. Respir. J. 2:640–642 (1989).
M. Molina and F. S. Rowlands. Stratospheric sinks for the chlorofluoro-methanes: Chlorine atom catalyzed destruction of otzone. Nature 249:1810–1812 (1974).
J. Yarbrough, R. N. Lyndon, E. Mansfield, and S. Ting. Metered dose inhaler induced bronchospasm in asthmatic patients. Ann. Allergy 55:25–27 (1985).
S. Pedersen and G. Stefersen. Fenoterol inhaler Technique in children: Influence of inspiratory flow rate and breath-holding. Eur. J. Respir. Dis. 68:207–214 (1986).
P. Camner. The production and use of test aerosols for studies of human tracheobronchial clearance. Environ. Physiol. 1:137–154 (1971).
S. P. Newman, D. Pavia, F. Moren, N. F. Sheahan, and S. W. Clarke. Deposition of pressurized aerosols in the human respiratory tract. Thorax 36:52–55 (1981).
B. M. Zainudin, S. E. J. Tolfee, M. Biddiscombe, M. Whittaker, M. D. Short, and S. G. Spiro. An alternative to direct labelling of pressurized bronchodilator aerosol. Int. J. Pharm. 51:67–71 (1989).
S. P. Newman, G. Woodman, S. W. Clarke, and M. A. Sackner. Effect of InspirEase on the deposition of metered-dose aerosols in the human respiratory tract. Chest 89:551–556 (1986).
D. Köhler, W. Fleischer, and H. Matthys. New method for easy labelling of beta-2-agonists in the metered dose inhaler with technetium 99m. Respiration 53:65–73 (1988).
M. T. Vidgren, A. Kärkkäinen, T. P. Paronen and, P. Karjalainen. Respiratory tract deposition of 99mTc-labelled drug particles administered via a dry powder inhaler. Int. J. Pharm. 39:101–105 (1987).
M. Vidgren, A. Kärkkäinen, P. Karjalainen, P. Paronen, and J. Nuutinen. Effect of powder inhaler design on drug deposition in the respiratory tract. Int. J. Pharm. 42:211–216 (1988).
S. P. Newman, F. Moren, E. Trofast, N. Talaee, and S. W. Clarke. Deposition and clinical efficacy of terbutaline sulphate from Turbuhaler, a new multi-dose powder inhaler. Eur. Respir. J. 2:247–252 (1989).
M. T. Vidgren, A. Kärkkäinen, P. Karjalainen, and T. P. Paronen. A Novel labelling method for measuring the deposition of drug particles in the respiratory tract. Int. J. Pharm. 37:239–244 (1987).
S. P. Newman, A. R. Clark, N. Talaee, and S. W. Clarke. Pressurized aerosol deposition in the human lung with and without an “open” spacer device. Thorax 44:706–710 (1989).
J. Arppe and M. Vidgren. Practical gamma labelling method for metered dose inhalers and inhalation powders. S.T.P. Pharma Sci. 4:19–22 (1994).
J. Arppe, P. Vidgren, P. Vainio, H. Tukiainen, and M. Vidgren. Effect of hand-lung coordination of the pulmonary deposition of salbutamol inhalation aerosol. Eur. J. Pharm. Biopharm. (In press).
G. W. Hallworth and U. G. Andrews. Size analysis of suspension inhalation aerosols by inertial separation methods. J. Pharm. Pharmacol. 28:898–907 (1976).
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Vidgren, M., Arppe, J., Vidgren, P. et al. Pulmonary Deposition and Clinical Response of99mTc-Labelled Salbutamol Delivered from a Novel Multiple Dose Powder Inhaler. Pharm Res 11, 1320–1324 (1994). https://doi.org/10.1023/A:1018902830192
Issue Date:
DOI: https://doi.org/10.1023/A:1018902830192