Key result
Ogrel demonstrated a 95% release of active dissolved clopidogrel compared to 97% for Plavix, with no statistically significant difference (p>0.05), indicating bioequivalence.
Why the study?
Are generic clopidogrel bisulfate products bioequivalent to branded Plavix in terms of in vitro dissolution?
Are generic clopidogrel bisulfate products bioequivalent to branded Plavix in terms of in vitro dissolution?
Answers are grounded in this paper and cite their sources.
Generic clopidogrel (Ogrel) demonstrates in vitro bioequivalence to Plavix and may be used as a cost-effective alternative.
Heart disease is widespread, and accounts for a quarter of all deaths in the US. Clopidogrel is used extensively for various cardiac conditions but has a high price. Cost-minimization analysis (CMA) differentiates alternative therapies based on price, given that all of the interventions have exactly the same health effects and must be bioequivalent when it comes to health benefits and adverse effects. Dissolution studies, using four marketed products, were conducted using a six stage, type II dissolution apparatus. Samples were analyzed at 240nm using a UV-VIS spectrophotometer. Concentration values of each sample, taken after 30 minutes were calculated from the calibration curve constructed with Clopidogrel Bisulfate RS. ANOVA was used to analyze any significant differences between the means of active dissolved. Plavix was found to have the highest percentage release of 97% but Ogrel had the least SEM of 3.9 with a percentage release of 95%. Lowplat and Pidogrel, although showed average percent releases of greater than 85%, their SEM and stand deviations were large showing widespread variations in unit contents. ANOVA gave a p>0.05, indicating a non-statistically significant difference between the means of active dissolved hence proving bioequivalence. CMA concluded that Ogrel may be used instead of the more expensive Plavix.
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Yahya et al. (2016) studied Heart disease. Ogrel (Clopidogrel Bisulfate) vs. Plavix was evaluated on Percentage release of active dissolved clopidogrel after 30 minutes (p=>0.05). Ogrel demonstrated a 95% release of active dissolved clopidogrel compared to 97% for Plavix, with no statistically significant difference (p>0.05), indicating bioequivalence.
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