PHARMACOKINETIC DRUG INTERACTIONS OF GLICLAZIDE AND ITOPRIDE IN NORMAL AND DIABETIC RATS
Objective: The present study was aimed to investigate the safety, reliability of Gliclazide and possible drug interaction with Itopride when they were administered as combination treatment.
Methods: Studies were conducted in normal and streptozotocin induced diabetic rats with oral administration of selected doses of gliclazide, itopride and their combination. Blood samples were collected from rats by retro orbital/marginal ear vein puncture at regular intervals of time. All the blood samples were analyzed for pharmacokinetic parameters by HPLC method.
Results: There was no significant difference in pharmacokinetic parameters of both Gliclazide alone and combination with itopride in healthy and diabetic rats on day 1 and day 8.
Conclusion: Based on the results it can be concluded that the concurrent administration of these two drugs have potential benefit without any drug interactions in the effective management of diabetes and gastroparesis.
2. Kassander P. Asymptomatic gastric retention in diabetics (gastroparesis diabeticorum). Ann Intern Med 1958;48:797-812.
3. Revicki DA, Rentz AM, Dubois D. Development and validation of a patient assessed gastroparesis symptom severity measure: the gastroparesis cardinal symptom index. Aliment Pharmacol Ther 2003;18:141-50.
4. Soykan I, Sivri B, Sarosiek I, Kiernan B, McCallum RW. Demography, clinical characteristics, psychological and abuse profiles, treatment, and long-term follow up of patients with gastroparesis. Dig Dis Sci 1998;43:2398-404.
5. Talley NJ, Young L, Bytzer P. Impact of chronic gastrointestinal symptoms in diabetes mellitus on health-related quality of life. Am J Gastroenterol 2001;96:71-6.
6. Enck P, Rathmann W, Spiekermann M. Prevalence of gastrointestinal symptoms in diabetic patients and non-diabetic subjects. Z Gastroenterol 1994;32:637-41.
7. Janatuinen E, Pikkarainen P, Laakso M, Pyorala K. Gastrointestinal symptoms in middle-aged diabetic patients. Scand J Gastroenterol 1993;28:427-32.
8. Maleki D, Locke GR III, Camilleri M. Gastrointestinal tract symptoms among persons with diabetes mellitus in the community. Arch Intern Med 2000;160:2808-16.
9. Bytzer P, Talley NJ, Leemon M, Young LJ, Jones MP, Horowitz M. Prevalence of gastrointestinal symptoms associated with diabetes mellitus: a population-based survey of 15,000 adults. Arch Intern Med 2001;161:1989-96.
10. Ballagi P, Gyorgy Koltai A, MÃ¡ria Z, Aranyi Z, PogÃ¡tsa G. "Divergent cardiac effects of the first and second generation hypoglycemic sulfonylurea compounds". Diabetes Res Clin Pract 1990;8:109â€“14.
11. Shimoyama, Tatsuhiro Y, Shinya T, Kazuto K, Hidenori I, Eisuke S, et al. Gliclazideprotects 3T3L1 adipocytes against insulin resistance induced by hydrogen peroxide with restoration of GLUT4 translocation. Metabolism 2006;55:722â€“30.
12. Del Guerra S, Grupillo M, Masini M, Lupi R, Bugliani M, Torri S, et al. Gliclazide protects human islet beta-cells from apoptosis induced by intermittent high glucose. Diabetes/Metab Res Rev 2007;23:234â€“8.
13. Katakami N, Yamasaki Y, Hayaishi-Okano R, Ohtoshi K, Kaneto H, Matsuhisa M, et al. Metformin or gliclazide, rather than glibenclamide, attenuate progression of carotid intima-media thickness in subjects with type 2 diabetes. Diabetologia 2004;47:1906â€“13.
14. Iwanaga Y, Miyashita N, Saito T, Morikawa K, Itoh Z. Gastroprokinetic effect of a new benzamide derivative itopride and its action mechanisms in conscious dogs. Jpn J Pharmacol 1996;71:129â€“37.
15. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med 2006;354:832â€“40.
16. Bose A, Wong TW, Singh N. Formulation development and optimization of sustained release matrix tablet of Itopride HCl by response surface methodology and its evaluation of release kinetics. Saudi Pharm J 2013;21:201â€“13.
17. Goyal RK, Joshi SS, Shah TS. Effects of chronic treatment with Nitrendipine in streptozotocin-induced diabetic rats. Indian J Pharm Sci 1996;58:100-5.
18. Sunil Kumar, Rashmika Kumar D. Evaluation of anti diabetic activity of euphoria hitralinn. In streptazocin induced diabetic rats. Indian J Nat Prod Resour 2010;1:200-3.
19. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, et al. Comparing generic and innovator drugs: a review of 12 y of bioequivalence data from the united states food and drug administration. Ann Pharmacother 2009;43:1583-97.
20. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003;25:2875-90.
21. Ramarao V, Shriharsha, Rajesham VV. Simultaneous estimation of Itopride and Gliclazide potassium by HPLC in API matrix. Am J Pharm Tech Res 2014;4:270-9.