The Pharmacokinetics of Nebulized Nanocrystal Budesonide Suspension in Healthy Volunteers

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...

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Bibliographic Details
Published in:Journal of clinical pharmacology 2004-01, Vol.44 (1), p.67-72
Main Authors: Kraft, Walter K., Steiger, Barry, Beussink, Don, Quiring, John N., Fitzgerald, Nancy, Greenberg, Howard E., Waldman, Scott A.
Format: Article
Language:English
Subjects:
Adult
asthma
Asthma - metabolism
Bronchodilator Agents - adverse effects
Bronchodilator Agents - pharmacokinetics
Budesonide - adverse effects
Budesonide - pharmacokinetics
budesonide absorption
Chemistry, Pharmaceutical
Cross-Over Studies
Female
Half-Life
Humans
Male
Nanobudesonide
nebulization
Nebulizers and Vaporizers
pharmacokinetics
Pulmicort Respules
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Summary: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.
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270003261490