Orally adminstrable opioid formulations having extended duration of effect

Abstract

Sustained release oral solid dosage forms of opioid analgesics are provided as multiparticulate systems which are bioavailable and which provide effective blood levels of the opioid analgesic for at least about 24 hours. A unit dose of the opioid analgesic contains a plurality of substrates including the opioid analgesic in sustained release form. The substrates have a diameter from about 0.1 mm to about 3 mm.

1 - 52 . (canceled) 
   
   
       53 : A sustained-release dosage form, comprising oxymorphone or a salt, a hydrophilic polymer, an alkylcellulose, a binder, and a diluent;
 wherein said dosage form provides a therapeutic effect for about 12 hours or more.   
   
   
       54 : The sustained-release dosage form of  claim 53 , wherein the dosage form contains granules having a diameter from about 0.1 mm to about 3 mm. 
   
   
       55 : The sustained-release dosage form of  claim 53 , wherein the alkylcellulose is ethylcellulose. 
   
   
       56 : The sustained-release dosage form of  claim 53 , wherein the dosage form is in the form of a tablet. 
   
   
       57 : The sustained-release dosage form of  claim 53 , wherein the dosage form is in the form of a capsule. 
   
   
       58 : The sustained-release dosage form of  claim 53 , wherein the dosage form is in the form of a matrix. 
   
   
       59 : The sustained-release dosage form of  claim 53 , wherein the dosage form provides a therapeutic effect for about 24 hours or more. 
   
   
       60 : A sustained-release dosage form, made by the process comprising: (a) mixing oxymorphone salt with a hyrodrophilic polymer, an alkylcellulose, a binder, and a diluent; (b) subjecting the mixture to shear to form granules; and (c) incorporating the granules into a dosage form;
 wherein said dosage form provides a therapeutic effect for about 12 hours or more.   
   
   
       61 : The process of  claim 60 , wherein the granules have a diameter from about 0.1 mm to about 3 mm. 
   
   
       62 : The process of  claim 60 , wherein step (c) comprises incorporating the granules into a tablet. 
   
   
       63 : The process of  claim 60 , wherein step (c) comprises incorporating the granules into a capsule. 
   
   
       64 : The process of  claim 60 , wherein the dosage form is a matrix. 
   
   
       65 : The process of  claim 60 , wherein the alkylcellulose is ethylcellulose. 
   
   
       66 : The process of  claim 60 , wherein the dosage form provides a therapeutic effect for about 24 hours or more. 
   
   
       67 : A process of making a sustained-release dosage form that provides a therapeutic effect for about 12 hours or more,
 which process comprises:   (a) mixing oxymorphone salt with a hydrophilic polymer, an alkylcellulose, a binder, and a diluent;   (b) subjecting the mixture to shear to form granules; and   (c) incorporating the granules into a dosage form.   
   
   
       68 : The process of  claim 67 , wherein the granules have a diameter from about 0.1 mm to about 3 mm. 
   
   
       69 : The process of  claim 67 , wherein step (c) comprises incorporating the granules into a tablet. 
   
   
       70 : The process of  claim 67 , wherein step (c) comprises incorporating the granules into a capsule. 
   
   
       71 : The process of  claim 67 , wherein the dosage form is a matrix. 
   
   
       72 : The process of  claim 67 , wherein the alkylcellulose is ethylcellulose. 
   
   
       73 : The process of  claim 67 , wherein the dosage form provides a therapeutic effect for about 24 hours or more.