Preparation and in vitro Drug Release of Ocular Thermosensitive Gel of Atropine Sulfate / 中国药师

ABSTRACT

Objective:To prepare the ocular thermosensitive gel of atropine sulfate and study its in vitro release. Methods: The gel formula was optimized by central composite design response surface methodology. The influences of the amounts of poloxamer 407 (P407) and poloxamer 188(P188) on gelling temperature before and after the dilution with simulated tear fluid were investigated. A membraneless dissolution model was used to determine the gel erosion and in vitro release. Results:The optimized gel formula was as follows:23% P407 and 5% P188. The deviations between the measured values and predicted values were all lower than 5%. The in vitro release experiment showed that the gel erosion and the drug release fitted zero-order kinetics equations with promising correlation, indicating a dissolution-controlled release mechanism. Conclusion:The optimization of the ocular thermosensitive gel of atropine sul-fate can be achieved by central composite design response surface methodology with good estimation. The thermosensitive gel with sus-tained drug release property meets the design requirements.