Oral Pharmaceutical Dosage Forms

Abstract

Abuse-resistant oral dosage forms suitable for administration of pharmacologically active agents are provided.

1 .- 34 . (canceled) 
     
     
         35 . A composition comprising a mixture comprising:
 a pharmacologically active agent;   sucrose acetate isobutyrate (SAM);   a cellulose acetate butyrate (CAB);   a rheology modifier selected from isopropyl myristate (IPM), caprylic/capric triglyceride, ethyl oleate, triethyl citrate, dimethyl phthalate, and benzyl benzoate;   a saturated polyglycolized glyceride (SPG); and   a solvent;   
       wherein the mixture is encapsulated within a capsule. 
     
     
         36 . The composition of  claim 35 , wherein the pharmacologically active agent is present in an amount ranging from about 1.3 wt % to about 35 wt %. 
     
     
         37 . The composition of  claim 35 , wherein the pharmacologically active agent is an opioid, a central nervous system (CNS) depressant, or a CNS stimulant. 
     
     
         38 . The composition of  claim 35 , wherein the pharmacologically active agent is an opioid. 
     
     
         39 . The composition of  claim 35 , wherein the pharmacologically active agent is an opioid selected from oxycodone, oxymorphone, hydrocodone, hydromorphone, either in free base form or a pharmaceutically acceptable salt form thereof 
     
     
         40 . The composition of  claim 35 , wherein the pharmacologically active agent is a CNS stimulant. 
     
     
         41 . The composition of  claim 35 , wherein the pharmacologically active agent comprises methylphenidate. 
     
     
         42 . The composition of  claim 35 , wherein the pharmacologically active agent comprises a pharmacologically acceptable salt of methylphenidate. 
     
     
         43 . The composition of  claim 35 , wherein the SAIB is present in an amount ranging from about 30 wt % to about 60 wt %. 
     
     
         44 . The composition of  claim 35 , wherein the CAB has a number average molecular weight ranging from about 66,000 to about 83,000. 
     
     
         45 . The composition of  claim 35 , wherein the CAB is present in an amount ranging from about 0.1 wt % to about 20 wt %. 
     
     
         46 . The composition of  claim 35 , wherein the rheology modifier is present in an amount ranging from about 0.1 wt % to about 20 wt %. 
     
     
         47 . The composition of  claim 35 , wherein the solvent is present in an amount ranging from about 0.1 wt % to about 40 wt %. 
     
     
         48 . The composition of  claim 35 , wherein the solvent is selected from triacetin, N-methyl-2-pyrrolidone, 2-pyrrolidone, dimethylsulfoxide, ethyl lactate, propylene carbonate, and glycofurol. 
     
     
         49 . The composition of  claim 35 , wherein the solvent comprises triacetin. 
     
     
         50 . The composition of  claim 35 , wherein the capsule comprises gelatin, hydroxyethylcellulose, or hydroxypropylmethylcellulose. 
     
     
         51 . The composition of  claim 35 , wherein the mixture further comprises a hydrophilic agent. 
     
     
         52 . The composition of  claim 51 , wherein the hydrophilic agent is selected from hydroxyethyl cellulose (HEC), hydroxylpropylcellulose, carboxymethylcellulose, polyethylene glycol, and polyvinylpyrrolidone. 
     
     
         53 . The composition of  claim 35 , wherein the mixture further comprises a silicon dioxide. 
     
     
         54 . A pharmaceutical dosage form comprising the composition of  claim 35 . 
     
     
         55 . A method of treating pain in a subject in need thereof, the method comprising:
 orally administering to the subject an effective amount of the composition of  claim 38 .