Patent ID: 8940729
Filing Date: 2015-01-27
Classification: A61K,A61P

Abstract:
1. A method for mitigating dose dumping comprising: administering a drug product comprising a drug substance consisting essentially of A-B-C wherein A is d-methylphenidate; C is an amine other than methylphenidate and B is a bidentate linking group defined by the formula: wherein Y R G R R R wherein said drug substance meets at least one condition in 0.1 N HCl selected from the group consisting of: a dissolution rate for said drug substance of no more than 35% of said drug substance is dissolved at 30 minutes with 5 wt % ethanol in said 0.1 N HCl; a dissolution rate for said drug substance wherein the percentage of said drug substance dissolved with at least 5 wt % ethanol in said 0.1 N HCl is no more than a percentage of said drug substance dissolved in said 0.1 N HCl without ethanol; and a dissolution rate for said drug substance wherein the percentage of drug substance dissolved with 40 wt % ethanol in 0.1 N HCl does not exceed 60% while the percentage of drug substance dissolved under the conditions selected from water, 0.1 N HCl, 5 wt % ethanol in 0.1 N HCl and 20 wt % ethanol in 0.1 N HCl does not exceed the drug substance dissolved with 40 wt % ethanol in 0.1 N HCl.