Influence of Various Media on the Dissolution Profiles of Immediate-Release Quetiapine Tablets in India

Dissolution testing was performed to evaluate the drug release from tablets. To mimic actual in vivo conditions, various foods and beverages were added to the dissolution media, and the release profiles were investigated. Indian people tend to have milk, curds, or eggs during their meals and then take their medications immediately after meals, whereas Americans tend to take medications with beverages. To evaluate drug release profiles in the presence and absence of these foods and beverages, in vitro dissolution testing was conducted using three different Indian quetiapine fumarate tablet brands. The effect on drug release was evaluated by adding 100 mL milk (3.1% protein), 100 g curd (4.1% protein), and 50 g raw and boiled egg white individually to 0.1 N HCl, and the release was compared with that in only 0.1 N HCl as per the Indian Pharmacopeia (IP) (1). The study was conducted for 3 h in triplicate, and the results show a significant difference among the brands in each medium with food. The maximum release obtained for each brand in 0.1 N HCl was 90%; in the presence of milk, curd, raw egg, and boiled egg it was approximately 7.06%, 2.42%, 29.56%, 24.08%, respectively, indicating that the drug was unavailable. Studies were also conducted with beverages and antacids; 200 mL of Thums Up, Sprite, and ENO were added individually to 0.1 N HCl and the release results compared. Results indicate a decrease of around 15% in availability in the presence of beverages and a 37% decrease in the presence of antacids. The results were statistically compared using one-way ANOVA at its Q value (45 min).