Immediate Release Abuse-Deterrent Granulated Dosage Forms

Abstract

Described are oral dosage forms that contain abuse-deterrent features and that contain core-shell polymers that include an active pharmaceutical ingredient, with particular examples including immediate release dosage forms that contain a drug that is commonly susceptible to abuse.

What is claimed is: 
     
         1 . An immediate release abuse deterrent dosage form comprising:
 a) core-shell particles, the core-shell particles comprising:   a core, the core comprising a gelling polymer, wherein the gelling polymer in the core is selected from a natural starch, a synthetic starch, a natural cellulose, a synthetic cellulose, an acrylate, a polyalkylene oxide, a carbomer and combinations thereof;   an active pharmaceutical layer surrounding the core, the active pharmaceutical layer comprising a narcotic analgesic;   at least one layer surrounding the active pharmaceutical layer, the at least one layer comprising a pH-sensitive film comprising pH-sensitive polymer that is insoluble in water at a pH greater than 5 and is soluble in water at a pH below 5; and   b) a matrix comprising a disintegrant and a gelling polymer; wherein the gelling polymer in the matrix is selected from a natural starch, a synthetic starch, a natural cellulose, a synthetic cellulose, an acrylate, a polyalkylene oxide, a carbomer, and combinations thereof.   
     
     
         2 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein less than 5 weight percent of the total amount of the narcotic analgesic in the core shell particles is contained in the core. 
     
     
         3 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein at least 90 percent of the total amount of the narcotic analgesic in the core shell particles is contained in the active pharmaceutical layer. 
     
     
         4 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the narcotic analgesic is an opioid. 
     
     
         5 . The immediate release abuse deterrent dosage form according to  claim 4 , further comprising a nonsteroidal analgesic drug. 
     
     
         6 . The immediate release abuse deterrent dosage form according to  claim 4 , wherein the opioid is selected from buprenorphine, codeine, dihydrocodeine, dihydromorphine, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, and pharmaceutically acceptable salts thereof. 
     
     
         7 . The immediate release abuse deterrent dosage form according to  claim 5 , wherein the nonsteroidal analgesic drug is selected from acetaminophen, aspirin, ibuprofen and naproxen. 
     
     
         8 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the gelling polymer in the core is selected from ethylcellulose, cellulose acetate, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose triacetate, cellulose ether, cellulose ester, cellulose ester ether, cellulose, an acrylic acid and methacrylic acid copolymer, a methyl methacrylate copolymer, an ethoxyethyl methacrylate, a cyanoethyl methacrylate, poly(acrylic acid), poly(methacrylic acid), methacrylic acid alkylamide copolymer, poly(methyl methacrylate), polymethacrylate, poly(methyl methacrylate) copolymer, polyacrylamide, aminoalkyl methacrylate copolymer, poly(methacrylic acid anhydride), glycidyl methacrylate copolymer, agar, acacia, karaya, tragacanth, algin, guar; polyacrylamide; water-swellable indene maleic anhydride polymer, hydroxypropyl methyl cellulose, hydroxy methyl cellulose, methyl cellulose, hydroxyethylmethyl cellulose, sodium carboxymethyl cellulose, a carbomer polymer, polyethylene oxide, polyvinyl alcohol and combinations thereof. 
     
     
         9 . The immediate release abuse deterrent dosage form according to  claim 8 , wherein the gelling polymer in the core is selected from hydroxypropyl methyl cellulose, hydroxy methyl cellulose, methyl cellulose, hydroxyethylmethyl cellulose, sodium carboxymethyl cellulose, a carbomer polymer, polyethylene oxide, polyvinyl alcohol and combinations thereof. 
     
     
         10 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the gelling polymer in the core is present in an amount from 0.5 to 15 weight percent based on the total weight of the dosage form. 
     
     
         11 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the gelling polymer in the matrix is selected from ethyl cellulose, cellulose acetate, cellulose acetate propionate, cellulose acetate butyrate, cellulose acetate phthalate, cellulose triacetate, cellulose ether, cellulose ester, cellulose ester ether, cellulose, an acrylic acid and methacrylic acid copolymer, a methyl methacrylate copolymer, an ethoxyethyl methacrylate, a cyanoethyl methacrylate, poly(acrylic acid), poly(methacrylic acid), methacrylic acid alkylamide copolymer, poly(methyl methacrylate), polymethacrylate, poly(methyl methacrylate) copolymer, polyacrylamide, aminoalkyl methacrylate copolymer, poly(methacrylic acid anhydride), glycidyl methacrylate copolymer, agar, acacia, karaya, tragacanth, algin, guar; polyacrylamide; water-swellable indene maleic anhydride polymer, hydroxypropyl methyl cellulose, hydroxy methyl cellulose, methyl cellulose, hydroxyethylmethyl cellulose, sodium carboxymethyl cellulose, a carbomer polymer, polyethylene oxide, polyvinyl alcohol and combinations thereof. 
     
     
         12 . The immediate release abuse deterrent dosage form according to  claim 11 , wherein the gelling polymer in the matrix is selected from hydroxypropyl methyl cellulose, hydroxy methyl cellulose, methyl cellulose, ethyl cellulose, hydroxyethylmethyl cellulose, sodium carboxymethyl cellulose, a carbomer polymer, and combinations thereof. 
     
     
         13 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the gelling polymer in the matrix is present in an amount from 0.5 to 15 weight percent based on the total weight of the dosage form. 
     
     
         14 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the disintegrant in the matrix is selected from corn starch, croscarmellose sodium, crospovidone, sodium starch glycolate, and combinations thereof. 
     
     
         15 . The immediate release abuse deterrent dosage form according to  claim 14 , wherein the dosage form comprises from 0.5 to 50 weight percent disintegrant based on total weight of the dosage form. 
     
     
         16 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the pH-sensitive polymer is a copolymer of dimethyl aminoethyl methacrylate, butyl methacrylate, and methyl methacrylate monomers. 
     
     
         17 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the dosage form excludes an emetic, a nasal irritant, and an effervescent. 
     
     
         18 . The immediate release abuse deterrent dosage form according to  claim 4 , wherein the dosage form excludes an opioid antagonist. 
     
     
         19 . The dosage form according to  claim 1 , wherein the dosage form, if ground and combined with a small volume of a solvent selected from ethanol, methanol, water, or a mixture thereof forms a composition having a viscosity that prevents uptake of the composition by a hypodermic syringe. 
     
     
         20 . The dosage form according to  claim 1 , wherein the dosage form reduces the risk of an overdose of the narcotic analgesic by simultaneous oral ingestion of multiple units of the oral dosage form. 
     
     
         21 . The dosage form according to  claim 1 , wherein the dosage form reduces the potential for abuse by simultaneous oral ingestion of multiple units of the oral dosage form. 
     
     
         22 . The dosage form of  claim 1 , wherein the dosage form is capable of releasing at least 75 weight percent of the narcotic analgesic into an aqueous hydrochloric acid solution within 240 minutes, the solution having a pH between 1 and 2 and a temperature of about 37 degrees Celsius. 
     
     
         23 . The immediate release abuse deterrent dosage form according to  claim 1 , wherein the dosage form is in a suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form. 
     
     
         24 . The immediate release abuse deterrent dosage form according to  claim 23 , wherein the dosage form is in a compressed tablet form. 
     
     
         25 . A method of preventing, alleviating, or ameliorating a level of pain in a subject, the method comprising administering to the subject a dosage form as recited at  claim 1 .