COMPARATIVE IN-VITRO BIOEQUIVALENCE STUDIES OF DIFFERENT SAMPLES OF TINIDAZOLE TABLETS

COMPARATIVE IN-VITRO BIOEQUIVALENCE STUDIES OF DIFFERENT SAMPLES OF TINIDAZOLE TABLETS

ABSTRACT

Health care professionals are faced with a large number of multisource products from which therapeutically equivalent products are being selected for various reasons. Consequently, an increased availability and use of generic products has been seen during the last four decades. Like most drugs, various brands of tinidazole tablets are available in Nigeria. This research was aimed at conducting an in-vitro bioequivalence studies on different samples of tinidazole tablets using simulated dissolution profiles. Four tablet samples of different brands of tinidazole were randomly purchased from major pharmaceutical shops within Kaduna metropolis and coded A, B, C and D. Quality control studies were conducted on each of the samples in accordance to standard procedures. Three UV spectrophotometric methods for the determination of tinidazole in simulated gastric, intestinal and blood pH were developed and validated. In vitro bioavailability study was then carried out using the dissolution test in the three media on each of the four samples. Bioavailability and bioequivalence of the various samples of tinidazole were studied using the in vitro- in vivo correlation (IVIVC) studies. The results of the studies indicated that the four tablet samples of tinidazole passed the weight uniformity test and the percentage friability test, but the disintegration test revealed that three out the four samples (including the innovator product, sample C) disintegrated in less than 15 minutes, except sample B which showed a non-uniform pattern of disintegration and failed to disintegrate even after 15 minutes. The three developed spectrophometric methods for the determination of tinidazole in simulated gastric, intestinal and blood pH were found to be linear in the ranges of 10-60, 2.5-40, and 5-50 µg/mL respectively. The regression equations of their calibration graphs and correlation coefficient were found to be y = vi 0.0263x - 0.035 and 0.998, y = 0.027x + 0.057 and 0.998; y = 0.029x - 0.014 and 0.994 for the simulated gastric, intestinal and blood pHs respectively. The bioavailabilities of all the four samples as measured using IVIVC studies were found to be 100 % in simulated blood pH. The bioavailabilities of brands A, B, C and D in simulated gastric pH were found to be 66.5, 85.8, 92.7 and 72.24 % respectively. In simulated intestinal pH, the bioavailabilities were 79.79, 90.57, 78.99, and 71.07 % for samples A, B, C and D respectively. The bioequivalence of samples A, B and D as a measure of similarity factor (f2) with respect to sample C (the innovator product) showed differences in bioavailability patterns which indicate the four tablet samples of tinidazole are not bioequivalent and cannot be used interchangeably. This is because none of the other three samples reach the similarity level of at least 50 % when compared to the innovator sample. In conclusion, quality control parameters of the four tablet samples of tinidazole studied were established and from the in vitro bioequivalent studies, the four samples of tinidazole tablets are not bioequivalent.

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