A RANDOMIZED CONTROLLED TRIAL OF CURCUMIN AND DICLOFENAC COMBINATION IN KNEE OSTEOARTHRITIS

Objective: The objective of the study was to evaluate pain relief and safety of the combination of curcumin and diclofenac versus diclofenac alone in the treatment of knee osteoarthritis (OA). Methods: 140 patients of knee OA meeting inclusion criteria were randomized to receive either curcumin 500 mg with diclofenac 50 mg twice daily or diclofenac 50 mg tablet alone twice daily for 28 d. Patients were assessed at baseline, Day 14 and Day 28. Primary efficacy measure was severity of pain (Visual Analogue Scale) at day 14 and day 28. Safety after treatment was evaluated by recording side effects and laboratory investigations. Results: Patients receiving curcumin plus diclofenac showed significantly superior improvement in severity of pain at each study visit (p<0.001) when compared to diclofenac. Adverse effects were significantly less in curcumin plus diclofenac group (p<0.001). Conclusion: Combination of curcumin and diclofenac showed a significant improvement in pain on the basis of VAS when compared to diclofenac which may be due to synergistic effect between curcumin and diclofena

A STUDY ON DRUG-DRUG INTERACTION BETWEEN GLIPIZIDE AND CIMETIDINE IN RABBITS

Objective: To study the effect of Cimetidine (H2 receptor antagonist) in combination with Glipizide (Sulfonylurea) on the blood sugar level in rabbits. Methods: Six albino rabbits were taken for the study. Glipizide was administrated to each rabbit as a single drug therapy on day 1 and it was co-administrated with Cimetidine to each rabbit as a combinational drug therapy on day 7. Cimetidine was administrated to each rabbit from day 2 to day 6 as single drug therapy. Blood sugar levels were estimated on day 1 and on day 7 at 0, 1, 2, 4, and 6 h. Results: The mean blood sugar level readings at 0, 1, 2, 4 and 6 h on day 1 were 90.4, 69.4, 62.9 and 65.7 mg% and on day 7 were 89.4, 74.8, 65.5, 56.4 and 61.2 mg % respectively. When mean blood sugar level on day 1 and day 7 was considered, there was a significant reduction in blood sugar level at 1, 2, 4 and 6 h and there was no significant fall in blood sugar level at 0 hour after co-administration of Glipizide and Cimetidine. Conclusion: Cimetidine, when co-administered with Glipizide, significantly increases the hypoglycaemic action of Glipizide

Pharmacokinetic profile of an intradeltoid diclofenac injection in obese Indian volunteers

Dhaneshwar Shep1, Ashwini Ojha2, Sweta Patel3, Manish Nivsarkar4, Vijaya Jaiswal1, Harish Padh51Medical Services, Troikaa Pharmaceuticals Ltd., 2Department of Bio-analytical, 3Department of Biostatistics, 4Department of Pharmacology and Toxicology, B.V. Patel Pharmaceutical Education and Research Development Centre, 5Director, B.V. Patel PERD Centre, and Project Director, NIPER, Ahmedabad, IndiaBackground: A new propylene glycol-free and reduced-volume formulation of diclofenac sodium 75 mg/mL designed for intradeltoid administration has been found to be bioequivalent to a reference formulation of diclofenac sodium 75 mg/3 mL given via the intragluteal route in normal healthy volunteers. Standard needles may not reach the gluteus maximus muscle in many cases, especially in the obese. The objective of this study was to determine the pharmacokinetic parameters of the new formulation and compare the bioavailability of intradeltoid diclofenac sodium 75 mg/mL with that of the intragluteal 75 mg/3 mL reference formulation in obese volunteers.Methods: A comparative, two-way, single-dose, bioavailability study was carried out in 10 obese (body mass index > 25) male Indian volunteers after a washout period of seven days. Blood samples were collected until six hours following drug administration and analyzed using a prevalidated high-pressure liquid chromatography method.Results: The mean maximum plasma concentration and time to reach maximum plasma concentration for the test formulation were 1.30 µg/mL and 0.50 hours, respectively, versus 0.93 µg/mL and 1.08 hours for the reference formulation. The mean areas under the curve from 0 to last measurable time point (AUC0–t) for the test and reference formulations were 2.71 µg•h/mL and 2.73 µg•h/mL, respectively. The mean AUCs from 0 to infinity (AUC0–∞) for the test and reference formulations were 3.71 µg•h/mL and 3.75 µg•h/mL, respectively.Conclusion: The results suggest that the test formulation of diclofenac sodium 75 mg/mL has an AUC0–t and AUC0–∞ comparable with the reference intragluteal formulation of diclofenac sodium 75 mg/3 mL, but with an earlier time to reach maximum plasma concentration and a trend towards a higher maximum plasma concentration. This could be attributed to faster absorption from the deltoid region than from the gluteal region. The test formulation could be helpful in the management of pain in obese or overweight patients and those with dense subcutaneous fat in the gluteal area.Keywords: bioavailability, diclofenac, intradeltoid, obese, pharmacokinetic