US2013165518A1PendingUtilityA1

Ibuprofen and narcotic analgesic compositions

Assignee: ABBVIE DEUTSCHLANDPriority: Jun 10, 1996Filed: Dec 7, 2012Published: Jun 27, 2013
Est. expiryJun 10, 2016(expired)· nominal 20-yr term from priority
A61P 25/04A61K 33/00A61K 31/485A61K 9/2059A61K 9/2077A61K 9/2054A61K 9/2009A61P 29/00A61K 31/192A61K 45/06
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Claims

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.

Claims

exact text as granted — not AI-modified
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;

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