Tamper Resistant Oral Dosage Forms

Abstract

Disclosed in certain embodiments is a solid oral dosage form comprising: (a) an inert tamper resistant core; and (b) a coating surrounding the core, the coating comprising an active agent.

1 . A solid oral dosage form comprising:
 (a) an inert tamper resistant core; and   (b) a coating surrounding the core, the coating comprising active agent.   
     
     
         2 .- 4 . (canceled) 
     
     
         5 . The solid oral dosage form of  claim 1 , wherein the tamper resistant core has a breaking strength of at least 400 Newtons. 
     
     
         6 . (canceled) 
     
     
         7 . The solid oral dosage form of  claim 1 , wherein the inert tamper resistant core comprises an inner component and an outer component surrounding the inner component. 
     
     
         8 . The solid oral dosage form of  claim 7 , wherein the inner component is tamper resistant, the outer component is tamper resistant or both the inner and outer components are tamper resistant. 
     
     
         9 . the solid oral dosage form of  claim 8 , wherein the outer component is tamper resistant. 
     
     
         10 . (canceled) 
     
     
         11 . The solid oral dosage form of  claim 9 , wherein the coating provides a controlled release of the active agent. 
     
     
         12 . The solid oral dosage form of  claim 11 , wherein the coating further comprises a pharmaceutically acceptable excipient. 
     
     
         13 .- 14 . (canceled) 
     
     
         15 . The solid oral dosage form of  claim 12 , wherein the excipient is a controlled release excipient. 
     
     
         16 . The solid oral dosage form of  claim 15 , wherein the controlled release excipient is selected from the group consisting of a cellulosic material, an acrylic polymer, and a combination thereof. 
     
     
         17 . The solid oral dosage form of  claim 16 , wherein the active agent is dispersed in the excipient. 
     
     
         18 . (canceled) 
     
     
         19 . The solid oral dosage form of  claim 1 , wherein the core comprises a pharmaceutically acceptable excipient. 
     
     
         20 . The solid oral dosage form of  claim 1 , wherein the core comprises a gelling agent. 
     
     
         21 . The solid oral dosage form of  claim 20 , wherein the gelling agent is selected from the group consisting of sugars, sugar derived alcohols, mannitol, sorbitol, starch, starch derivatives, cellulose derivatives, microcrystalline cellulose, sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, attapulgites, bentonites, dextrins, alginates, carrageenan, gum tragacanth, gum acacia, guar gum, xanthan gum, pectin, gelatin, kaolin, lechitin, magnesium aluminum silicate, carbomers, carbopols, polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, silicon dioxide, surfactants, mixed surfactant and wetting agent systems, emulsifiers, and mixtures thereof. 
     
     
         22 .- 29 . (canceled) 
     
     
         30 . The solid oral dosage form of  claim 1 , wherein the active agent is susceptible to abuse. 
     
     
         31 . The solid oral dosage form of  claim 30 , wherein the active agent is selected from the group consisting of opioid analgesics, tranquilizers, CNS depressants, CNS stimulants, sedatives, hypnotics, stimulants, and cannabinoids. 
     
     
         32 . The solid oral dosage form of  claim 31 , wherein the active agent is an opioid analgesic selected from the group consisting of codeine, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, tramadol, pharmaceutically acceptable salts, complexes, stereoisomers, ethers, esters, hydrates, solvates, and mixtures thereof. 
     
     
         33 .- 40 . (canceled) 
     
     
         41 . A method of preparing a solid oral dosage form comprising:
 (a) preparing an inert tamper resistant core; and   (b) surrounding the core with a coating comprising an active agent.   
     
     
         42 . (canceled) 
     
     
         43 . A method of treating pain comprising administering to a patient in need thereof, a solid oral dosage form of  claim 32 . 
     
     
         44 .- 51 . (canceled) 
     
     
         52 . The method of  claim 41 , wherein the tamper resistant core has a breaking strength of at least 400 Newtons. 
     
     
         53 . The method of  claim 41 , wherein the inert tamper resistant core comprises an inner component and an outer component surrounding the inner component.