Drug Enhancement of Bioavailability of Nizatidine Drug by using Different Coating Materials
Author(s): Kameswara Rao S, Bharghava Bhushan Rao P*, Chekumuki Venkata Naveen Kumar, Murikipudi Priya Teja, Venkata Naga Sai Manikanta, Jonnalagadda Yamini Priya and Vinay Kumar T
Abstract
Nizatidine is an effective new H2 receptor antagonist. Nizatidine is a specific, long acting H2 receptor antagonist. It is indicated for the treatment of duodenal ulcer, gastric ulcer, GERD and Zollinger-Ellison Syndrome. In this study 40 mg Nizatidine tablets were formulated and coated with 2 different coating materials i.e. HPMC and opadry white, to check the effect of these coating materials on the bioavailability of Nizatidine tablets. In vitro techniques like disintegration test and dissolution test were used to evaluate Nizatidine tablets. Disintegration test was performed on both the formulations. Mean disintegration time for formulation 1 was found to be 5 minutes and mean disintegration time for formulation 2 was 3 minutes. The results of dissolution after 120 minutes for formulation 1 showed release up to 100.01% and the formulation 2 was released up to 100.05%. For in vivo evaluation these 2 formulations were administered to 8 normal human subjects with 1 week washout period. Blood samples were collected and plasma was obtained and analysized by HPLC. Pharmacokinetic parameters of formulation 1 were Cmax 0.97 μg/ ml ±0.47 μg/ml, tmax was 1.68 hours ± 0.37 hours, AUC 3.97 μg.h/ml ± 1.61 μg.h/ml, AUMC 13.35 μg.h2/ml ± 5.97 μg.h2/ml, MRT 2.27 hours ± 0.55 hours, Ke 0.394 ± 0.052, T1/2 1.97 hours ± 0.38 hours, Vd 5.78 L/Kg ± 4.45 L/Kg, Vss 1.92 ± 0.68 L/Kg, Cl 2.08 ml/h/Kg ± 0.08 ml/h/Kg and for formulation 2 these values were 1.64 μg/ml ± 1.02 μg/ml, 1.5 hours ± 0.46 hours, 10.07 μg.h/ml ± 0.21 μg.h/ml, 11.06 μg.h2/ml ± 0.64 μg.h2/ml, 2.38 hours ± 0.99 hours, 0.394 ± 0.07, 1.97 hours ± 0.69 hours, 6.309 L/ Kg ± 2.72 L/Kg, 1.61 L/Kg ± 0.118 L/Kg, 1.76 ml/h/Kg ± 0.037 ml/h/Kg respectively. Statistical analysis was performed and it was found that the formulation 2 which was coated with opadry white was more bioavailable than formulation 1 which was coated with HPMC. It was also concluded that coating materials affect the bioavailability of Nizatidine tablets.
