Ibuprofen and Narcotic analgesic compositions

Abstract

Provided herein are compositions and methods of making compositions of ibuprofen in combination with a narcotic analgesic. Specifically provided is a pharmaceutical tablet composition comprising ibuprofen; a narcotic analgesic; colloidal silicon dioxide; a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose; a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate; a binder consisting of an akylhydroxy methylcellulose; a starch; and a lubricant. Also provided herein is a method of preparing a pharmaceutical tablet composition comprising: (a) Granulating ibuprofen, a narcotic analgesic, a first glidant, a first disintegrant, a binder, and starch to form granules wherein said granulating step comprises a wet granulation process; (b) blending the granules with extra-granular material comprised of a second glidant, a second disintegrant, a filler and starch to form a blend of granules and extra-granular material; and (c) compressing the blend into a tablet.

We claim:  
     
         1 . A pharmaceutical composition comprising a granule comprised of ibuprofen and a narcotic analgesic in a single phase.  
     
     
         2 . The composition as recited in  claim 1  further comprising a blend of the granule and extra granule material.  
     
     
         3 . A tablet composition comprising the compressed composition of claim.  
     
     
         4 . A pharmaceutical tablet composition comprising: 
 (a) an effective amount of ibuprofen;    (b) an effective amount of a narcotic analgesic;    (c) colloidal silicon dioxide wherein the weight of the colloidal silicon dioxide is provided in a range, of the total weight of the tablet, of about 0.5% to about 3%;    (d) a filler selected from the group consisting of microcrystalline cellulose and powdered cellulose;    (e) a disintegrant selected from the group consisting of croscarmellose sodium, crospovidone, and sodium starch glycolate;    (f) a binder consisting of an akylhydroxy methylcellulose wherein the weight of the binder is provided in a range, of the total weight of the tablet composition, of about 2% to less than 6%;    (g) a starch provided in a weight range, of total weight of the tablet composition, of about 11% to about 28%; and    (h) a lubricant wherein the lubricant is provided in an amount less than 1% by weight of the total weight of the tablet;    wherein the tablet comprises a compressed blend of a granule and extra granule material wherein the granule comprises at least a portion of the ibuprofen, at least a portion of the narcotic analgesic, a portion of the colloidal silicon dioxide, a portion of the disintegrant, and a portion of the starch and the weight of the extra granule material is provided in a range of up to about 25% of the weight of the whole tablet.    
     
     
         5 . The composition as recited in  claim 4  wherein the weight of the filler is provided in a range, of the total weight of the tablet composition, of about 10% to about 42%.  
     
     
         6 . The composition as recited in  claim 4  wherein the weight of the disintegrant is provided in a range, of the total weight of the tablet composition, of about 4% to about 10%.  
     
     
         7 . The composition as recited in  claim 5  wherein the weight of the disintegrant is provided in a range, of the total weight of the tablet composition, of about 4% to about 10%.  
     
     
         8 . A pharmaceutical tablet composition comprising: 
 (a) an effective amount of ibuprofen wherein the weight of the ibuprofen is provided in a range, of the total weight of the tablet composition, of up to about 50%;    (b) an effective amount of hydrocodone;    (c) colloidal silicon dioxide provided in a range, by total weight of the tablet composition, of about 1.5% to about 2%;    (d) microcrystalline cellulose provided in a range, of the total weight of the tablet composition, of about 15% to about 25%.;    (e) a disintegrant selected from the group consisting of croscarmellose sodium and crospovidone wherein the weight of the disintegrant is provided in a range, of the total weight of the tablet composition, of about 6 to about 8%.    (f) a binder consisting of an akylhydroxy methylcellulose wherein the weight of the binder is provided in a range, of the total weight of the tablet composition, of about 3% to about 4%;    (g) corn starch wherein the weight of the corn starch is provided in a range, of the total weight of the tablet composition, of about 11 to about 17%; and    (h) a lubricant wherein the weight of the lubricant is provided in an amount less than 1% by weight of the total weight of the tablet;