Amphetamine carbamate compounds and methods
AssigneeNoven Pharmaceuticals, Inc.
InventorDeboprosad Mondal
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Abstract
Described herein are methods for quantitatively determining the amount of the amphetamine-related compound identified herein as amphetamine carbamate (amphetammonium-amphetacarbamate) present in a drug-containing polymer matrix comprising amphetamine, and for assessing a drug-containing polymer matrix comprising amphetamine. The methods may comprise converting any amphetacarbamate present into reaction products comprising carbonate, quantifying the amount of carbonate, and quantifying the amphetacarbamate originally present from the quantified amount of carbonate.
Claims10
A method of quantitatively determining the amount of amphetacarbamate in a drug-containing polymer matrix comprising amphetamine as an active pharmaceutical ingredient (API) and polymer components, comprising:
- (a) processing the drug-containing polymer matrix with an organic solvent to separate the polymer components from the amphetamine and any amphetacarbamate present and obtain a composition comprising amphetamine and amphetacarbamate (if present) in solution;
- (b) subjecting the composition comprising amphetamine and amphetacarbamate (if present) to ion chromatography under an inert atmosphere with an eluent comprising a basic hydroxide ion under conditions that permit in situ reaction of any amphetacarbamate present with the hydroxide ions to produce a carbonate ion;
- (c) quantifying the amount of carbonate in the reaction products;
- and
- (d) quantifying the amphetacarbamate originally present in the polymer matrix from the quantified amount of carbonate in the reaction products and the stoichiometric relationship between amphetacarbamate and carbonate in the reaction of step (b).
Dependencies are inferred from the claim text.