Less abusable pharmaceutical preparations
View Patent ↗The present invention is directed to pharmaceutical compositions of psychoactive drugs having a reduced potential for abuse and methods of reducing the potential for abuse of dosage forms of prescription psychoactive drugs.
1. A dosage form having reduced abuse potential comprising:
(a) a first population of granules, beads or minitablets comprising a psychoactive drug, and
(b) a second population of drug-free granules, beads or minitablets comprising:
(i) a core comprising at least one deterrent substance selected from the group consisting of activated charcoal and alumina and
(ii) a coating surrounding the core, wherein said coating does not dissolve in the gastrointestinal tract and comprises a polymer selected from the group consisting of cellulose acetate, cellulose acetate butyrate, cellulose acetate propionate, ethyl cellulose, poly(ethyl acrylate), poly(methyl methacrylate), and poly(trimethylammonioethylmethacrylate chloride),
which is further coated with an alkaline soluble coating comprising a polymer selected from the group consisting of cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methyl cellulose phthalate, polyvinyl acetate phthalate, carboxymethylethylcellulose, and co-polymerized methacrylic acid/methacrylic acid methyl esters, and
wherein the deterrent substance does not interact with the drug when properly administered.
2. A dosage form having reduced abuse potential comprising:
(a) a first population of granules, beads or minitablets comprising a psychoactive drug, and
(b) a second population of drug-free granules, beads or minitablets comprising:
(i) a core comprising at least one ionically binding substance selected from the group consisting of styrene-divinyl benzene sulfonates and
(ii) a coating surrounding the core, wherein said coating is a non-dissolving coating comprising a polymer selected from the group consisting of cellulose acetate, cellulose acetate butyrate, cellulose acetate propionate, ethyl cellulose, poly(ethyl acrylate), poly(methyl methacrylate), and poly(trimethylammonioethylmethacrylate chloride),
which is further coated with an alkaline soluble coating comprising a polymer selected from the group consisting of cellulose acetate phthalate, cellulose acetate trimellitate, hydroxypropyl methyl cellulose phthalate, polyvinyl acetate phthalate, carboxymeth lethylcellulose, and co-polymerized methacrylic acid/methacrylic acid methyl esters,
wherein the ionically binding substance forms an ion-associated complex with the drug in an aqueous environment so to lower the solubility of the drug compared to its unbound form, but does not interact with the drug when properly administered.