Methods and compositions for self-regulated release of active pharmaceutical ingredient
AssigneeAbuse Deterrent Pharmaceuticals, LLC
InventorsAlbert W. Brzeczko, R. Gary Hollenbeck
Life of this patent
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Abstract
An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.
Claims46
An abuse deterrent pharmaceutical composition comprising a unit dose, the unit dose comprising:
- a particle portion, wherein the particle portion comprises:
- a. a pharmaceutically active ingredient;
- b. an acid soluble ingredient comprising a cationic copolymer based on methyl methacrylate;
- and
- c. magnesium hydroxide;
- and
- a pH modifying ingredient,
- wherein the pH modifying ingredient is present in an amount sufficient to inhibit dissolution of the particle portion when three unit doses or greater of the abuse deterrent pharmaceutical composition is ingested, and
- wherein the acid soluble ingredient and the pH modifying ingredient retard release of the pharmaceutically active ingredient when the three unit doses or greater of the composition is ingested.
An abuse deterrent pharmaceutical composition comprising a unit dose, the unit dose comprising:
- a particle portion, wherein the particle portion comprises:
- a. a pharmaceutically active ingredient;
- b. an acid soluble ingredient comprising one or more of calcium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, and magnesium hydroxide;
- and
- c. a buffering ingredient;
- and
- a pH modifying ingredient,
- wherein the pH modifying ingredient is present in an amount sufficient to inhibit dissolution of the particle portion when three unit doses or greater of the abuse deterrent pharmaceutical composition is ingested, and
- wherein the acid soluble ingredient and the pH modifying ingredient retard release of the pharmaceutically active ingredient when the three unit doses or greater of the composition is ingested.
An abuse deterrent pharmaceutical composition comprising an immediate release unit dose, the immediate release unit dose comprising:
- a. a pharmaceutically active ingredient;
- b. an acid soluble ingredient comprising a cationic polymer;
- and
- c. a buffering ingredient,
- wherein the buffering ingredient is in an amount sufficient to increase the gastric pH above 4 and the release of the active ingredient is retarded when at least 3 unit doses are ingested.
Dependencies are inferred from the claim text.