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Modified release ibuprofen dosage formRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Tablets, Lozenges, Or PillsModified release ibuprofen dosage form description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070077297, Modified release ibuprofen dosage form. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATIONS [0001] The present invention is a continuation-in-part of U.S. application Ser. No. 11/238,802, filed Sep. 29, 2005, which claims the benefit of U.S. Provisional Applications Nos. 60/614,932, filed Sep. 30, 2004 and 60/689,631, filed Jun. 10, 2005. BACKGROUND OF THE INVENTION [0002] Ibuprofen is 2-(4-isobutylphenyl)propionic acid and is a non-steroidal anti-inflammatory compound (NSAID), which exhibits high levels of anti-inflammatory, analgesic and antipyretic activities necessary for the effective treatment of rheumatoid arthritis and osteo-arthritis and other inflammatory conditions. Most dosage forms of ibuprofen are immediate release dosage forms that provide rapid onset of therapeutic action, then rapidly declining levels of active ingredient, necessitating repeated dosing. They do not maintain therapeutic levels from one treatment over an extended period of time. Repeat dosing is thus required at intervals of four to six hours. Formulations that claim extended release fail to have an initial burst of the drug and thus exhibit substantial delay between administration and the achievement of an effective therapeutic blood level. Therefore, a need exists for a solid dosage form, for example a compressed tablet, which provides an initial burst of released ibuprofen, leading to prompt onset of action, then thereafter provides a sustained release of sufficient ibuprofen to maintain beneficial blood levels of ibuprofen over an extended period of 8 or more hours. [0003] It is known ibuprofen is not directly compressible, and attempts to directly manufacture ibuprofen results in tablets which stick to the faces of the tableting press, are too friable for storage or transport, or split into two or more segments when expelled from the tableting press. To circumvent those manufacturing problems, those skilled in the art carry out a preliminary step prior to tableting, in which ibuprofen is wet granulated with a microcrystalline cellulose additive to form a granular composition comprising ibuprofen and microcrystalline cellulose, which is then capable of blending with further excipients and/or is directly compressible for the manufacture of a suitable solid dosage form. Therefore, a need exists for a dry blend of ibuprofen which is suitable for manufacture of a satisfactory tableted dosage form, obviating the need for a pre-granulation step. SUMMARY OF THE INVENTION [0004] In accordance with the foregoing, we have provided a solid dosage form for oral administration of ibuprofen comprising a modified release formulation of ibuprofen which provides an immediate burst effect and thereafter a sustained release of sufficient ibuprofen to maintain blood levels at least 6.4 .mu.g/ml over an extended period of at least 8 hours following administration of a single dose. [0005] More particularly, the invention comprises a solid dosage form for oral administration comprising a hydrophilic polymer, a pharmaceutically effective amount of ibuprofen in the range of 300 mg to 800 mg uniformly dispersed in the polymer, a dissolution additive dispersed in the polymer in an amount in the range of 10% to 35% by weight of the ibuprofen, and a formulation additive dispersed in the polymer in an amount of 15% to 75% by weight of the ibuprofen. The dosage form releases ibuprofen at a rate sufficient to initially deliver an effective amount of ibuprofen within about 2.0 hours following administration. The dosage form then subsequently delivers the remaining amount of ibuprofen at a relatively constant rate sufficient to maintain a level of ibuprofen over a predetermined delivery period of for at least 8 hours. [0006] As used herein, a relative constant rate refers to a substantially linear relationship shown in the examples following the initial burst (up to about 2 hours) between percentage released and elapsed time. BRIEF DESCRIPTION OF THE DRAWINGS [0007] FIG. 1: In-vitro dissolution of Example 1 [0008] FIG. 2: In-vitro dissolution of Example 2 [0009] FIG. 3: In-vitro dissolution of Example 3 [0010] FIG. 4: In-vitro dissolution of Example 4 [0011] FIG. 5: In-vitro dissolution of Example 5 [0012] FIG. 6: In-vitro dissolution of Example 6 [0013] FIG. 7: In-vitro dissolution of Example 7 [0014] FIG. 8: In-vitro dissolution of Example 8 [0015] FIG. 9: In-vitro dissolution of Example 9 [0016] FIG. 10: In-vitro dissolution of Example 10 [0017] FIG. 11: In-vitro dissolution of Example 11 [0018] FIG. 12: In-vitro dissolution of Example 12 [0019] FIG. 13: In-vitro dissolution of Example 13 [0020] FIG. 14: In-vitro dissolution of Example 14 Continue reading about Modified release ibuprofen dosage form... Full patent description for Modified release ibuprofen dosage form Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Modified release ibuprofen dosage form patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Modified release ibuprofen dosage form or other areas of interest. ### Previous Patent Application: Method and composition for pharmaceutical product Next Patent Application: Pharmaceutical preparation containing meloxicam Industry Class: Drug, bio-affecting and body treating compositions ### FreshPatents.com Support Thank you for viewing the Modified release ibuprofen dosage form patent info. 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