A pharmacokinetic analysis of diclofenac potassium soft-gelatin capsule in patients after bunionectomy.

作者: Mark Kowalski , Douglas G Stoker , Charles Bon , Keith A Moore , Stephen E Boesing

DOI: 10.1097/MJT.0B013E3181AA3EDA

关键词:

摘要: The clinical utility of diclofenac potassium, a nonsteroidal anti-inflammatory drug, may be lessened by inconsistent gastrointestinal absorption. Diclofenac potassium liquid filled soft-gelatin capsule (DPSGC) is an investigational formulation that uses ProSorb dispersion technology to facilitate rapid and consistent In this study, the pharmacokinetic (PK) properties DPSGC are investigated compared with commercially available oral tablet in patients after primary unilateral first metatarsal bunionectomy. open-label, randomized 53 received ProSorb-D 12.5 mg (the equivalent DPSGC), 25 mg, 50 or immediate-release 50-mg administered every 8 hours for 24-hour inpatient period followed 7 days outpatient dosing. steady-state PK was evaluated over 8-hour sampling 4 surgery. Delayed and/or multiple peaks plasma concentration-time course profiles occurred more frequently than other formulations. data 12.5-mg liquid, revealed mean peak concentrations (C max ) 302, 749, 1006, 902 ng/mL, respectively, whereas area under concentration curve values were 316, 595,1029, 1166 ng-hour/mL, respectively. Mean times C (t 0.49, 0.63, 0.95, 1.26 h, When absorption characteristics tablet, rapidly consistently absorbed These should advantageous when pain relief desired.

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