The Pharmacokinetics of Nebulized Nanocrystal Budesonide Suspension in Healthy Volunteers
- 1 January 2004
- journal article
- clinical trial
- Published by Wiley in The Journal of Clinical Pharmacology
- Vol. 44 (1), 67-72
- https://doi.org/10.1177/0091270003261490
Abstract
Nanocrystal budesonide (nanobudesonide) is a suspension for nebulization in patients with steroid‐responsive pulmonary diseases such as asthma. The pharmacokinetics and safety of the product were compared to those of Pulmicort Respules. Sixteen healthy volunteers were administered nanobudesonide 0.5 and 1.0 mg, Pulmicort Respules 0.5 mg, andplacebo in a four‐way, randomizedcrossover design. All nebulized formulations were well tolerated, with no evidence of bronchospasm. Nebulization times were significantly shorter for nanobudesonide compared to Pulmicort Respules. Because of a low oral bioavailability, plasma concentration of budesonide is a good marker of lung‐delivered dose. The pharmacokinetics of nanobudesonide 0.5 and 1.0 mg were approximately dose proportional with respect to Cmax, AUC(0‐t), and AUC(0‐∞). Nanobudesonide 0.5 mg and Pulmicort Respules 0.5 mg exhibited similar AUCs, suggesting a similar extent of pulmonary absorption. A higher Cmax was noted with nanobudesonide 0.5 mg, and the tmax was significantly different, suggesting a more rapid rate of drug delivery of nanobudesonide 0.5 mg than Pulmicort Respules. In conclusion, nebulized nanobudesonide 0.5 mg was safe in healthy volunteers, with a similar extent of absorption as Pulmicort Respules.Keywords
This publication has 22 references indexed in Scilit:
- Effect of Long-Term Treatment with Inhaled Budesonide on Adult Height in Children with AsthmaNew England Journal of Medicine, 2000
- Airway remodeling and persistent airway obstruction in asthmaJournal of Allergy and Clinical Immunology, 1999
- Improved delivery of inhaled steroids to the large and small airwaysRespiratory Medicine, 1998
- Efficacy of nebulized budesonide in treatment of severe infantile asthma: A double-blind studyJournal of Allergy and Clinical Immunology, 1996
- Nebulized budesonide for the treatment of moderate to severe asthma in infants and toddlers*Acta Paediatrica, 1996
- Effects of Reducing or Discontinuing Inhaled Budesonide in Patients with Mild AsthmaNew England Journal of Medicine, 1994
- Treatment of severe steroid dependent preschool asthma with nebulised budesonide suspension.Archives of Disease in Childhood, 1993
- Comparison of a β2-Agonist, Terbutaline, with an Inhaled Corticosteroid, Budesonide, in Newly Detected AsthmaNew England Journal of Medicine, 1991
- Growth of asthmatic children during treatment with budesonide: a double blind trial.BMJ, 1991
- A study of the mechanism of the antiasthmatic action of inhaled budesonideJournal of Allergy and Clinical Immunology, 1990