A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
A61K 31/4415 (2006.01) A61K 9/20 (2006.01) A61K 9/28 (2006.01) A61K 31/4402 (2006.01) A61P 1/08 (2006.01)
Patent
CA 2350195
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 measured in 1000 ml phosphate buffer at pH 6.8 and 37°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 silica flow conditioner and a stabilizing agent.
Duchesnay Inc.
Goudreau Gage Dubuc
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