Methods and compositions for self-regulated release of active pharmaceutical ingredient
View Patent ↗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.
1. An abuse deterrent pharmaceutical composition comprising an immediate release unit dose of:
a. a pharmaceutically active ingredient;
b. an acid soluble ingredient comprising a cationic copolymer based on dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate; and
c. a buffering ingredient;
wherein the acid soluble ingredient and the buffering ingredient retard release of the pharmaceutically active ingredient when three unit doses or greater of the composition is ingested and wherein the buffering ingredient comprises one or more of calcium carbonate, sodium bicarbonate, magnesium oxide, tribasic sodium phosphate, or combinations thereof and is present in the amount of 45-95 wt % of the pharmaceutical composition.
2. The composition of claim 1 , wherein the pharmaceutically active ingredient comprises a drug susceptible to abuse.
3. The composition of claim 1 , wherein the pharmaceutically active ingredient comprises a drug with narrow therapeutic index.
4. The composition of claim 1 , wherein the acid soluble ingredient comprises calcium carbonate, cationic copolymer, or combinations thereof.
5. The composition of claim 1 , wherein the pharmaceutically active ingredient is contained within a matrix of the acid soluble ingredient.
6. The composition of claim 1 , wherein the acid soluble ingredient is present in an amount of about 1 wt % to about 40 wt % of the pharmaceutical composition.