Compositions and methods for reducing overdose

摘要

Drug delivery formulations, uses thereof and methods of making same are provided in order to reduce the potential for abuse, misuse or improper administration of an addictive substance or any active substance and to prevent, reduce, inhibit, or delay purposeful or accidental overdose of an active substance by ingesting too many dosage forms at once, for example.

主权项

1. A unit dose formulation comprising:
at least one active substance; at least one acid labile coat partially, substantially, or completely surrounding said at least one active substance; and at least one alkalinizing coat partially, substantially, or completely surrounding said at least one acid labile coat, wherein said at least one alkalinizing coat is present in an amount sufficient to raise the pH of the stomach, such that dissolution of said at least one acid labile coat and release of said at least one active substance is inhibited when the number of unit dosage forms ingested exceeds a predetermined number of at least 1, and wherein at least one alkalinizing agent is present in said at least one alkalinizing coat in an amount such that: when less than a predetermined number of unit dose formulations is ingested, the gastric pH remains sufficiently acidic to dissolve said at least one acid labile coat and/or active substance and release said at least one active substance; and when the predetermined number or more of the unit dose formulations is ingested, the gastric pH is alkalinized sufficiently to inhibit dissolution of said at least one acid labile coat and/or active substance and release of said at least one active substance.