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.

1 . A pharmaceutical composition comprising a granule comprised of ibuprofen, a narcotic analgesic, and a lubricant in a single phase, wherein the granule is formed by a wet granulation. 
     
     
         2 . (canceled) 
     
     
         3 . A tablet composition comprising the compressed composition of  claim 1 . 
     
     
         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 alkylhydroxy 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, wherein the granule is formed by a wet granulation process; and wherein the ibuprofen, the narcotic analgesic, and the lubricant are present in the tablet in a single phase.   
     
     
         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 alkylhydroxy 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;   wherein the granule is formed by a wet granulation process; and wherein the ibuprofen, the hydrocodone, and the lubricant are present in the tablet in a single phase.