Abstract
The aim of the study was to evaluate if two capsules (Amoxil® capsules, 500 mg/capsule) and one tablet (Amoxicare® tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. For this purpose a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy, male volunteers, divided into two groups of 12 subjects each. One group was treated with the reference standard (Amoxil®) and the other one with the generic tablet Amoxicare®, with a crossover after a wash-out period of 7 days. Blood samples were collected at fixed time intervals and amoxicillin was determined by a validated HPLC method. The pharmacokinetic parameters AUC0-8, AUC0-∞, Cmax, Tmax, Ke and T1/2 were determined for both formulations and statistically compared to evaluate the bioequivalence between the two brands of amoxicillin, using the statistical model recommended by the FDA. Cmax and AUC0-∞ were statistically analyzed using analysis of variance (ANOVA); no statistically significant difference was observed between the two formulations. The 90% confidence intervals between the mean values of Cmax and AUC0-∞ fall within the FDA specified bioequivalent limits (80-125%) suggesting that the two products are bioequivalent and the two formulations are interchangeable. Based on these findings it was concluded that the practice of interchangeability between the above formulations to achieve better patient compliance could be followed without compromising the extent of amoxicillin absorption.
Highlights
The aim of the study was to evaluate if two capsules (Amoxil® capsules, 500 mg/capsule) and one tablet (Amoxicare® tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters
Few publications are found in literature demonstrating potential interchangeability of two different solid dosage forms based on pharmacokinetic data . [5,6] The aim of the present study was to determine if the practice of interchangeability between two amoxicillin capsules (Amoxil®, 500 mg/capsule) and one amoxicillin tablet (Amoxicare®, 1000 mg/tablet) in order to achieve better patient compliance can be conducted without compromising their extent of absorption
The accuracy of the method was validated as the intra-day accuracy was in the range from 95 to 109% and the inter-day accuracy was in the range of 93 to 109% during the entire period in which calibration curves were generated
Summary
The aim of the study was to evaluate if two capsules (Amoxil® capsules, 500 mg/capsule) and one tablet (Amoxicare® tablets, 1000 mg/tablet) of amoxicillin have similar bioequivalence parameters. The 90% confidence intervals between the mean values of Cmax and AUC0-∞ fall within the FDA specified bioequivalent limits (80-125%) suggesting that the two products are bioequivalent and the two formulations are interchangeable Based on these findings it was concluded that the practice of interchangeability between the above formulations to achieve better patient compliance could be followed without compromising the extent of amoxicillin absorption. 1) is a commonly prescribed orally available β-lactam antibiotic with moderate antibacterial spectrum that is available on the market as different dosage forms and in strengths It is available as 1000 mg tablet and as 500 mg capsules. All these www.ijpsonline.com factors may make the administration of tablets an uncomfortable experience leading to poor patient compliance In such cases, substitution of large volume tablet with two capsules containing the same drug strength can solve problems associated with swallow ability. Few publications are found in literature demonstrating potential interchangeability of two different solid dosage forms based on pharmacokinetic data . [5,6] The aim of the present study was to determine if the practice of interchangeability between two amoxicillin capsules (Amoxil®, 500 mg/capsule) and one amoxicillin tablet (Amoxicare®, 1000 mg/tablet) in order to achieve better patient compliance can be conducted without compromising their extent of absorption
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