Concomitant medications were recorded at baseline. trazodone and m-chlorophenyl-piperazine; aspirin and salicylate). Statistical methods for obtaining confidence intervals for individual and population bioequivalence criteria. Given the recent emergence of potentially serious cardiovascular toxicity associated with selective COX-2 inhibitors, nonsteroidal antiinflammatory drugs (NSAIDs), which inhibit both COX-1 and COX-2, have received renewed attention as candidate chemoprevention agents.
ANOVA models were used to test for significant differences between formulations while accounting for a possible crossover effect.
Subjects were also advised to avoid alcoholic and caffeinated beverages for ≥24 h before agent administration and until all venipuncture samples had been obtained. The U.S. Food and Drug Administration has approved sulindac for treating acute gouty arthritis, acute painful shoulder (bursitis/tendonitis), osteoarthritis, and rheumatoid arthritis (The study was designed as a single-dose, two-period crossover trial and was conducted through the National Cancer Institute–sponsored, multidisciplinary Cancer Prevention Network.
Overall, bioavailability appeared to be higher for the capsule compared with the tablet formulation based on test-to-reference pharmacokinetic variable ratios for the parent compound alone.
Women of childbearing potential were required to document a negative pregnancy test before enrollment. Conduct and analysis of bioavailability and bioequivalence studies. Guidance for Industry. Sulindac capsule and tablet formulations appear to provide similar chemopreventive exposure based on the pharmacokinetic analysis of the sulindac sulfide and sulindac sulfone metabolites. Springer Guidance for industry: statistical approaches to establishing bioequivalence. Encapsulation of the parent compound (sulindac sulfoxide) can be readily accomplished, but the effects of alternate formulations on bioavailability have not been rigorously examined. Agents were stored in a secure area at controlled room temperature (20-25°C). 1986;33(1):46-51. doi: 10.1159/000138199.Xenobiotica. Bulk supplies were packaged, labeled, and distributed by Fisher BioServices. To further current understanding of sulindac bioavailability, metabolism, and disposition, we developed a population pharmacokinetic model for the parent compound and its active metabolites, sulindac sulfide, and exisulind. Dosage forms: TAB: 150 mg, 200 mg osteoarthritis [150-200 mg PO bid] Start: 150 mg PO bid; Max: 400 mg/day; Info: use lowest effective dose, shortest effective tx duration; give w/ food if … Very small amounts of the sulindac and sulfone were detected in the urine samples, and no sulfide was detected in urine after sulindac dosing (data not shown). Individual doses were repackaged and labeled by experienced pharmacy personnel at the Outpatient Cancer Therapy Drug Preparation Area, Mayo Clinic Rochester. Since the first case series of colorectal polyp regression mediated by sulindac among familial adenomatous polyposis patients was reported over two decades ago (Sulindac is a commercially available, prescription NSAID that is approved in 34 countries (Martindales Extra Pharmacopeia), including the United States. The circumstances in which a role for active dr … Hg vacuum pressure. Standard curves were linear (The high-performance liquid chromatography system consisted of a Shimadzu liquid chromatograph with a SCL-10Avp system controller, SIL-10ADvp autoinjector (injection volume, 20 μL) fitted for 96-well plates, LC-10ADvp pump (flow rate, 1.0 mL/min), DGU-14A degasser, a FCV-10ALVP low pressure gradient unit, and SPD10-AVvp UV-Visible detector (wavelength, 340 nm). DOPA and cyclophosphamide); active metabolites which contribute to the duration of action of the parent compound (e.g. 1994 Jul;115(3):320-4. doi: 10.1007/BF02245072.J Pharmacokinet Biopharm. levels of sulindacand its active metabolites,sulindacsulfone and sulindac sulfide (Fig.
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