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The Pharmacokinetics of Nebulized Nanocrystal Budesonide Suspension in Healthy Volunteers

From the Division of Clinical Pharmacology, Departments of Medicine (Dr. Kraft, Dr. Waldman, Dr. Greenberg) and Biochemistry and Molecular Pharmacology (Dr. Waldman), Thomas Jefferson University, Philadelphia; Sheffield Pharmaceuticals, Rochester, New York (Dr. Steiger, Dr. Beussink); and QST Consultations Ltd., Allendale, Michigan (Dr. Quiring, Ms. Fitzgerald).

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, and placebo in a four-way, randomized crossover 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 C_max, 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 C_max was noted with nanobudesonide 0.5 mg, and the t_max 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.

Key Words: Nanobudesonide • Pulmicort Respules • asthma • nebulization • budesonide absorption • pharmacokinetics

Address for reprints: Walter K. Kraft, MD, Division of Clinical Pharmacology, 1170 Main Building, 132 S. 10th Street, Philadelphia, PA 19107.

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