| 摘要 |
Provided herein is a novel enterically-coated pyridoxine HCl and doxylamine succinate rapid onset formulation for treating nausea and vomiting comprising a disintegrating agent such that the following dissolution profiles are satisfied when measur ed in 1000 ml phosphate buffer at pH 6.8 and 37.degree.C in a type 2 dissolution apparatus at 100 rpm: (a) at least about 40% of the total pyridoxine HCl and doxylamine succinate is dissolved after 30 minutes of measurement; (b) at least about 70% of the total pyridoxine HCl and doxylamine succinate is dissolved after 60 minutes of measurement; (c) at least about 80% of the total pyridoxine HCl and doxylamine succinate is dissolved after 90 minutes of measurement; (d) at about 90% of the total pyridoxine HCl and doxylamine succinate is dissolved after 120 minutes of measurement. Preferably the formulation will contain a core coated with at least one enteric coating, the core comprising pyridoxine HCl, doxylamine succinate and the following non- active excipients: a filler or binder, a disintegrating agent, a lubricant, a silic a flow conditioner and a stabilizing agent. |
