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|Title:||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.|
|Inventor(s):||Kushla; Gregory P. (Florham, NJ), Lai; Jin-Wang (Edison, NJ), Polli; Gerald P. (Valley Forge, PA)|
|Assignee:||Abbott GmbH & Co. KG (Wiesbaden, DE)|
|Filing Date:||Dec 16, 2004|
|Claims:||1. A pharmaceutical 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 not less than 70% of the ibuprofen or the hydrocodone is released at 30 minutes in 900 mL of pH phosphate buffer, at 37.degree. C. using baskets at 150 revolutions per minute, wherein said composition has acceptable disintegration, dissolution and compression characteristics wherein the tablet has compression forces from 5 to 20 kN with no substantial change in the disintegration time of the tablet, and wherein said composition is substantially free of lactose. |
2. The pharmaceutical composition of claim 1, wherein 100% of the ibuprofen and the hydrocodone is released in 10 minutes.
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