Claims for Patent: 8,865,187

Summary for Patent: 8,865,187

Title:	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)
Application Number:	12/883,873
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,865,187
Patent Claims:	1. A pharmaceutical composition that is a non-steroidal anti-inflammatory drug (NSAID)-in-oil suspension, comprising a lecithin oil consisting of soy lecithin components in sunflower oil, wherein said lecithin oil has about 33-40 wt. % phosphatidylcholine (PC), about 26-31 wt. % triglycerides, about 8-13 wt. % free fatty acids, and about 5-9 wt. % glycolipids and a solid NSAID, wherein (a) the NSAID associates with a phospholipid of the lecithin oil, (b) the NSAID is present in a therapeutically effective amount, and (c) the composition has a gastrointestinal (GI) toxicity that is reduced relative to the NSAID alone. 2. A pharmaceutical composition that is an NSAID-in-oil suspension and that is the product of a process that comprises admixing an NSAID as a powder into a lecithin oil consisting of soy lecithin components in sunflower oil, wherein said lecithin oil has about 33-40 wt. % PC, about 26-31 wt. % triglycerides, about 8-13 wt. % free fatty acids, and about 5-9 wt. % glycolipids, such that: (a) the composition contains a NSAID that is associated with a phospholipid of the lecithin oil; (b) the NSAID is present in a therapeutically effective amount; and (c) the composition has a GI toxicity that is reduced relative to that of the NSAID alone. 3. A pharmaceutical composition according to claim 1, wherein the NSAID is selected from the group consisting of aspirin, indomethacin, and ibuprofen. 4. A pharmaceutical composition according to claim 2, wherein the NSAID is selected from the group consisting of aspirin, indomethacin, and ibuprofen. 5. A pharmaceutical composition according to claim 3, wherein the NSAID is aspirin. 6. A pharmaceutical composition according to claim 4, wherein the NSAID is aspirin. 7. A pharmaceutical composition according to 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. 8. A pharmaceutical composition according to claim 1, wherein the weight ratio of NSAID to lecithin oil is about 1:1. 9. A pharmaceutical composition according to claim 2, 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. 10. A pharmaceutical composition according to claim 2, wherein the weight ratio of NSAID to lecithin oil is about 1:1.