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|Title:||Methods of making compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity|
|Abstract:||A novel pharmaceutical composition is provided by which nonsteroidal anti-inflammatory drugs (NSAIDs) are added directly to phospholipid-containing oil such as lecithin oils or to a bio-compatible oil to which an phospholipid has been added to make a NSAID-containing formulation that possess low gastrointestinal (GI) toxicity and enhanced therapeutic activity to treat or prevent inflammation, pain, fever, platelet aggregation, tissue ulcerations and/or other tissue disorders. The composition of the invention are in the form of a non-aqueous solution, paste, suspension, dispersion, colloidal suspension or in the form of an aqueous emulsion or microemulstion for internal, oral, direct or topical administration.|
|Inventor(s):||Lichtenberger; Lenard M. (Houston, TX)|
|Assignee:||The Board of Regents of the University of Texas System (Austin, TX)|
|Filing Date:||Sep 16, 2010|
|Claims:||1. A method for producing a pharmaceutical composition that is a NSAID-in-oil suspension, said method comprising admixing a NSAID in powder form into a lecithin oil to obtain a NSAID-in-oil suspension, such that the NSAID (i) associates with phospholipids in the lecithin oil and (ii) is present in a therapeutically effective amount and the NSAID-in-oil suspension has a gastrointestinal toxicity that is reduced relative to the NSAID alone, wherein said NSAID is selected from the group consisting of aspirin, indomethacin and ibuprofen. |
2. The method of claim 1, wherein the NSAID is aspirin.
3. The method of claim 1, wherein the weight ratio of NSAID to lecithin oil present in the NSAID-in-oil suspension is from about 4:1 to about 1:4.
4. The method of claim 3, wherein the weight ratio of NSAID to lecithin oil is about 1:1.
5. The method of claim 1, wherein said lecithin oil comprises about 35% phosphatidylcholine.
6. The method of claim 2, wherein said lecithin oil comprises about 35% phosphatidylcholine.