| Pharmacokinetics of a novel submicron budesonide dispersion for nebulized delivery in asthma. | |
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MedLine Citation:
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PMID: 18786624 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The objective of this study was to evaluate the safety and pharmacokinetics of unit dose budesonide (UDB), an aqueous dispersion of submicron-sized budesonide particles, and a commercially available budesonide suspension formulation. This was a randomized, double-blind, active-controlled, 4-period, 4-way crossover trial in 16 healthy, adult volunteers. Subjects received UDB 0.24, 0.12, and 0.06 mg or commercial budesonide 0.25 mg via a jet nebulizer. T(max) was significantly (p<0.05) earlier for UDB 0.06, 0.12, and 0.24 mg (4.5+/-3.3, 3.1+/-1.5, 3.7+/-1.5 min) vs. commercial budesonide (9.1+/-7.1 min). C(max) was significantly (p<0.05) higher for UDB 0.24 mg vs. commercial budesonide 0.25 mg (434.5+/-246.9 pg/mL vs. 303.5+/-177.4 pg/mL) but not between UDB 0.12 mg (239.9+/-140 pg/mL) and commercial budesonide 0.25 mg (p=0.448). AUC(0-infinity) was marginally, but significantly lower for UDB 0.24 mg than commercial budesonide 0.25 mg. AUCs for UDB 0.12 mg were lower than commercial budesonide 0.25 mg. UDB 0.24 mg was absorbed more rapidly and achieved higher peak concentrations than commercial budesonide 0.25 mg, but had a lower AUC(0-infinity). UDB 0.12 mg also was absorbed more rapidly but had lower C(max) and AUCs than commercial budesonide 0.25 mg. |
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Authors:
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Stephen B Shrewsbury; Andrew P Bosco; Paul S Uster |
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Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2008-08-22 |
Journal Detail:
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Title: International journal of pharmaceutics Volume: 365 ISSN: 0378-5173 ISO Abbreviation: Int J Pharm Publication Date: 2009 Jan |
Date Detail:
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Created Date: 2008-12-09 Completed Date: 2009-03-09 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7804127 Medline TA: Int J Pharm Country: Netherlands |
Other Details:
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Languages: eng Pagination: 12-7 Citation Subset: IM |
Affiliation:
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MAP Pharmaceuticals Inc., Mountain View, CA 94043, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Inhalation Adult Area Under Curve Asthma / drug therapy* Bronchodilator Agents / administration & dosage, adverse effects, pharmacokinetics* Budesonide / administration & dosage, adverse effects, pharmacokinetics* Chemistry, Pharmaceutical Cross-Over Studies Dose-Response Relationship, Drug Double-Blind Method Female Humans Male Nebulizers and Vaporizers Particle Size Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Bronchodilator Agents; 51333-22-3/Budesonide |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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