Methods and compositions for self-regulated release of active pharmaceutical ingredients

Abstract

An abuse deterrent pharmaceutical composition including a drug susceptible to abuse, a first acid soluble ingredient, a first buffering ingredient, and a delayed release buffering component.

What is claimed is: 
     
         1 . A pharmaceutical composition limiting the effects of over-ingestion of the product comprising:
 a drug susceptible to over-ingestion;   a first acid soluble ingredient;   a first buffering ingredient; and   an ingredient for increasing gastric emptying time.   
     
     
         2 . The composition of  claim 1 , wherein the first acid soluble ingredient comprises calcium carbonate, a cationic copolymer, or a combination thereof. 
     
     
         3 . The composition of  claim 2 , wherein the cationic copolymer comprises one or more of dimethylaminoethyl methacrylate, butyl methacrylate, or methyl methacrylate. 
     
     
         4 . The composition of  claim 1 , wherein the first buffering ingredient comprises calcium carbonate, sodium bicarbonate, magnesium oxide, tribasic sodium phosphate, or combinations thereof. 
     
     
         5 . The composition of  claim 1 , wherein the ingredient for increasing gastric emptying time is selected from a monosaccharide, a disaccharide, an oligosaccharide, an amino acid, a peptide, a protein, a monoglyceride, a diglyceride, or a triglyceride. 
     
     
         6 . The composition of  claim 1 , wherein the ingredient for increasing gastric emptying time is selected from loperamide, diphenoxylate, atropine, difenoxin, an anticholinergic, an antidepressant, an opioid, an antidiarrheal drug, or a gastroparesis inducing drug. 
     
     
         7 . The composition of  claim 1 , wherein the composition further comprises a delayed release buffering component. 
     
     
         8 . The composition of  claim 7 , wherein the delayed release buffering component further comprises one or more of a second acid soluble ingredient, a second buffering ingredient, an enteric ingredient, and a sustained-release ingredient. 
     
     
         9 . The composition of  claim 8 , wherein the second acid soluble ingredient comprises calcium carbonate, a cationic copolymer, or combinations thereof. 
     
     
         10 . The composition of  claim 9 , wherein the cationic copolymer comprises one or more of dimethylaminoethyl methacrylate, butyl methacrylate, or methyl methacrylate. 
     
     
         11 . The composition of  claim 8 , wherein the second acid soluble ingredient is the same as the first acid soluble ingredient. 
     
     
         12 . The composition of  claim 8 , wherein the second buffering ingredient comprises calcium carbonate, sodium bicarbonate, magnesium oxide, tribasic sodium phosphate, or combinations thereof. 
     
     
         13 . The composition of  claim 8 , wherein the second buffering ingredient is the same as the first buffering ingredient. 
     
     
         14 . The composition of  claim 8 , wherein the enteric ingredient comprises one or more of shellac, methyl acrylate-methacrylic acid copolymers, cellulose acetate phthalate, cellulose acetate succinate, hydroxypropyl methyl cellulose phthalate, hypromellose acetate succinate, polyvinyl acetate phthalate, sodium alginate, or zein. 
     
     
         15 . The composition of  claim 1 , wherein the composition further comprises an ingredient for decreasing gastric acid production. 
     
     
         16 . The composition of  claim 15 , wherein the ingredient for decreasing gastric acid production comprises an H2-antagonist. 
     
     
         17 . The composition of  claim 16 , wherein the H2-antagonist is present in an amount that is 10-50% of the lowest therapeutic dose of the H2 antagonist for reducing stomach acid secretion. 
     
     
         18 . The composition of  claim 1 , wherein upon ingestion by a subject, the ingredient for increasing gastric emptying time increases the gastric emptying time of the subject. 
     
     
         19 . A dosage form comprising the composition of  claim 1 . 
     
     
         20 . A method of treating a disease alleviated by a drug susceptible to over-ingestion, comprising:
 administering to a subject in need thereof a composition of  claim 1 .