Document Detail


Simultaneous and minimally invasive assessment of muscle tolerance and bioavailability of different volumes of an intramuscular formulation in the same animals.
MedLine Citation:
PMID:  16612034     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Evaluation of skeletal muscle tolerance during development of new drug formulations for i.m. use is most often based on terminal methods performed in the target species after slaughtering. The objective of this study was to evaluate the effect of muscle damage on the pharmacokinetic parameters of the drug delivered into the muscle using an alternative, noninvasive method. Phenylbutazone (PBZ) was used as the test article. Six ewes received increasing volumes of a 20% PBZ i.m. formulation, according to a cross-over design, and an i.v. bolus of the same formulation. Serial blood samples were taken, and a pharmacokinetic analysis of the plasma activity of creatine kinase and plasma PBZ concentrations was carried out. The amount of muscle damage after i.m. administration of 2, 4, or 8 mL of PBZ, calculated from the area under the curve of plasma creatine kinase across time was 36, 76, and 178 g for a 70-kg ewe. The corresponding absolute bioavailability of PBZ was 100 +/- 32%, 96 +/- 19%, and 100 +/- 17%, and the maximal PBZ concentrations were 42 +/- 3.4, 74 +/- 8.8, and 119 +/- 18.2 microg/mL. The plasma clearance of PBZ (i.v.) was 4.2 +/- 0.94 mL.kg(-1).h(-1). In conclusion, the absolute bioavailability of PBZ after i.m. administration was not altered by the increased volume of formulation administered despite the overall increase in the extent of muscle damage.
Authors:
P J Ferre; V Laroute; J P Braun; J Cazaux; P L Toutain; H P Lefebvre
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Publication Detail:
Type:  Clinical Trial; Journal Article    
Journal Detail:
Title:  Journal of animal science     Volume:  84     ISSN:  1525-3163     ISO Abbreviation:  J. Anim. Sci.     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-04-13     Completed Date:  2006-10-19     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8003002     Medline TA:  J Anim Sci     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1295-301     Citation Subset:  IM    
Affiliation:
Unité Mixte de Recherche 181 INRA/ENVT, Experimental Pathophysiology and Toxicology, National Veterinary School of Toulouse, 23 Chemin des Capelles, BP 87614, 31076 Toulouse cedex 03, France.
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MeSH Terms
Descriptor/Qualifier:
Animals
Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*,  adverse effects*,  pharmacokinetics
Biological Availability
Chemistry, Pharmaceutical
Creatine Kinase / blood
Cross-Over Studies
Dose-Response Relationship, Drug
Female
Half-Life
Injections, Intramuscular
Muscle, Skeletal
Phenylbutazone / administration & dosage*,  adverse effects*,  pharmacokinetics
Random Allocation
Sheep*
Chemical
Reg. No./Substance:
0/Anti-Inflammatory Agents, Non-Steroidal; 50-33-9/Phenylbutazone; EC 2.7.3.2/Creatine Kinase

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