Curcumin is the lipid-soluble antioxidant compound obtained from the rhizome of Curcuma longa Linn, also known as turmeric. Curcumin targets multiple chemotherapeutic and inflammatory pathways and has demonstrated safety and tolerability in humans, supporting its potential as a therapeutic agent; however, the clinical literature lacks conclusive evidence supporting its use as a therapeutic agent due to its low bioavailability in humans. The purpose of this study was to quantify plasma levels of free curcumin after dosing of a solid lipid curcumin particle (SLCP) formulation versus unformulated curcumin in healthy volunteers and to determine its tolerability and dose-plasma concentration relationship in late-stage osteosarcoma patients. Doses of 2, 3, and 4 g of SLCP were evaluated in 11 patients with osteosarcoma. Plasma curcumin levels were measured using a validated high-performance liquid chromatography method. The limit of detection of the assay was 1 ng/mL of curcumin. In healthy subjects, the mean peak concentration of curcumin achieved from dosing 650 mg of SLCP was 22.43 ng/mL, whereas plasma curcumin from dosing an equal quantity of unformulated 95% curcuminoids extract was not detected. In both healthy individuals and osteosarcoma patients, high interindividual variability in pharmacokinetics and nonlinear dose dependency was observed, suggesting potentially complex absorption kinetics. Overall, good tolerability was noted in both healthy and osteosarcoma groups.
Oxidative stress occurs in diabetic patients and experimental models of diabetes. The ability of L-arginine to ameliorate oxidative stress after treatment with alloxan was investigated in rats. Adult male rats were injected intraperitoneally with multiple doses of alloxan to produce experimental oxidative stress characteristic of diabetes mellitus. The rats were maintained in this state for eight weeks. Rats were decapitated and gastrointestinal tissues were isolated. The results were interpreted and the significance was analyzed using unpaired, two-tailed Student's t tests and two-way repeated measures ANOVA. Hyperglycemia was observed in the plasma after three days of alloxan treatment. This was associated with a depression of glutathione (GSH) concentration as well as superoxide dismutase (SOD) and catalase (CAT) activities in the pylorus and ileum. In addition, the malonyldialdehyde (MDA) levels were significantly elevated, indicating increased lipid peroxidation and oxidative stress in the same tissues. L-arginine supplementation (0.15 mg/ml) through drinking water until eight weeks after alloxan injection significantly ameliorated the oxidative stress, as evidenced by lower MDA levels as well as higher levels of endogenous GSH, SOD, and CAT (p < 0.001). These effects were paralleled by marked protection and prophylaxis against alloxan-induced hyperglycemia. Thus, exogenously administered L-arginine might improve the clinical manifestation of diabetes mellitus and decrease the oxidative stress in the gastrointestinal tract. In addition, the study supports the beneficial effects of L-arginine. These effects might be attributed to its direct, NO-dependent antioxidant capacity and/or NO-independent pathways.
The goal of present work was to investigate the effects of rupturable material ethyl cellulose combines with erodible material Klucel EXF on the pulsatile release pattern of Candesartan cilexetil in order to prevent morning rise in blood pressure. A tablet prepared by compression coating method contains core and coat components. Core consists of active ingredients with its various superdisintegrants where as coat contains different grades of ethyl cellulose and Klucel HXF in various combinations. All these tablets were evaluated for its micromeritics, weight variations, hardness, friability and in vitro dissolution testing. Drug-excipients interactions were carried out by FTIR. Dissolution studies were carried out in simulated gastric fluid followed by phosphate buffer of pH 6.5. The optimized formulation PT6 which give lag time of 6 hrs and released 99.10 % within 7 hr, as well as found to be stable in ICH stability testing guidelines.
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