Compositions comprising non steroidal anti-inflammatory drugs and methods of use thereof

Abstract

The invention provides analgesic, antipyretic, anti-inflammatory, and anti-neoplastic compositions containing epilactose in combination with non-steroidal anti-inflammatory drugs and pharmaceutically acceptable zinc compounds. This invention relates to the use of these novel compositions for significantly improved and synergistic safety and therapeutic profiles.

What is claimed is: 
     
         1 . A composition comprising i) aspirin, methyl salicylate, diclofenac, or meloxicam in an amount of about 0.075 mg per unit dose to about 900 mg per unit dose; ii) epilactose in an amount of about 0.014 mg per unit dose to about 600 mg per unit dose; and iii) zinc in an amount of about 0.015 mg per unit dose to about 890 mg per unit dose, wherein the composition has a Synergy Index less than 1.0. 
     
     
         2 . The composition of  claim 1  wherein zinc consists essentially of zinc carnosine. 
     
     
         3 . The composition of  claim 1  wherein a condition in a mammal, a human, a livestock animal or a companion animal is treated with the composition. 
     
     
         4 . The composition of  claim 1  wherein the composition is administered to a subject. 
     
     
         5 . The composition of  claim 1  wherein i) aspirin, methyl salicylate, diclofenac, or meloxicam and ii) epilactose are provided in separate dosage units as a liquid, solid, semi solid or combinations thereof. 
     
     
         6 . The composition of  claim 1  wherein the composition is formulated to delivery any of i) aspirin, methyl salicylate, diclofenac, or meloxicam; ii) epilactose; or iii) zinc to a subject's plasma, whole blood, serum, urine, saliva, cerebral spinal fluid or secretions at a rate to achieve a sustained release of the composition. 
     
     
         7 . The composition of  claim 1  wherein the composition is formulated to release 1 to 99 percent of the total unit dose of i) aspirin, methyl salicylate, diclofenac, or meloxicam; ii) epilactose; or iii) zinc or combinations thereof in an in-vitro system, with or without the use of a medium having a pH ranging from 1 to 8.5. 
     
     
         8 . The composition of  claim 1  prepared in the form of a tablet, capsule, granule, sphere, or multi-particulate preparation, and wherein i) aspirin, methyl salicylate, diclofenac, or meloxicam; ii) epilactose; or iii) zinc are located in any of the core, matrix, or coating layer of hard shell capsules, soft gel capsules, or microcapsules. 
     
     
         9 . The composition of  claim 1  wherein the composition is formulated in a medication form which contains one or more carrier. 
     
     
         10 . The composition of  claim 9  wherein the carrier comprises one or more of calcium silicate, carbomers, carboxy methyl cellulose, carrageenan, chitosan, colloidal silicone dioxide, gelatin, glyceryl palmitostearate, guar gum, hydroxy ethyl cellulose, hydroxy propyl cellulose, hydroxy ethyl methyl cellulose, microcrystalline cellulose and sodium carboxymethyl cellulose, polyethylene oxide, polyethylene glycol, polyethylene alkyl ethers, polymethacrylates, propylene carbonate, sodium ascorbate, sorbitol, sodium alginate, alginic acid, urethane, acacia, bentonite, cetostearyl alcohol, cyclomethicon, ethyl cellulose, glycerin, glyceryl behenate, hydrogenated vegetable oil type i, hypromellose, magnesium aluminum silicate, maltitol, maltodextrin, methyl cellulose, polydextrose, polyvinyl acetate phthalate, polyvinyl alcohol, propyl alcohol, butyl alcohol, potassium chloride, povidone, propylene glycol alginate, tragacanth, xanthan gum, starch of natural and/or synthetic origin, natural or synthetic cellulose derivatives of organic or inorganic acids and salts, monovalent/divalent/trivalent/tetravalent metallic salts of glycerols/organic acids/carboxylic acids, talc, hydrogenated oils of natural or synthetic origin, natural and/or synthetic gums or combinations thereof. 
     
     
         11 . The composition of  claim 9  wherein the carrier is a solid, semisolid, solution, emulsion, dispersion, micelle, liposome, suspension, powder or combinations thereof. 
     
     
         12 . The composition of  claim 9  wherein the carrier comprises drug reservoirs, transporters, solubility enhancers, drug release modifiers, absorption enhancers, bioavailability modifiers, ADME modifiers, lubricants, disintegrants, diluents, binders, plasticizers, surfactants, fillers, colorants, or pH modifiers. 
     
     
         13 . The composition of  claim 9  wherein said carrier effects the rate of drug delivery by forming drug matrix reservoirs, undergoing ionic reactions, or forming molecular complexes. 
     
     
         14 . The composition of  claim 1  wherein the composition is formulated to deliver any of aspirin, methyl salicylate, diclofenac, or meloxicam; ii) epilactose; or iii) zinc to a subject's plasma, whole blood, serum, urine, saliva, cerebral spinal fluid or secretions at a rate to achieve a rapid release of the composition. 
     
     
         15 . The composition of  claim 1  wherein the composition is formulated to deliver any of aspirin, methyl salicylate, diclofenac, or meloxicam; ii) epilactose; or iii) zinc to a subject's plasma, whole blood, serum, urine, saliva, cerebral spinal fluid or secretions at a rate to achieve a slow release of the composition. 
     
     
         16 . The composition of  claim 1  wherein the composition is formulated to deliver any of aspirin, methyl salicylate, diclofenac, or meloxicam; ii) epilactose; or iii) zinc to a subject's plasma, whole blood, serum, urine, saliva, cerebral spinal fluid or secretions at a rate to achieve a sustained release of the composition. 
     
     
         17 . A method of treating a subject with an inflammatory condition, the method comprising administering to the subject a composition comprising i) aspirin, methyl salicylate, diclofenac, meloxicam, ibuprofen, celecoxib or naproxen in an amount of about 0.075 mg per unit dose to about 900 mg per unit dose; ii) epilactose in an amount of about 0.014 mg per unit dose to about 600 mg per unit dose; and iii) zinc in an amount of about 0.015 mg per unit dose to about 890 mg per unit dose, wherein the composition has a Synergy Index less than 1.0. 
     
     
         18 . A method for treating cancer, comprising the step of administering to a patient in need of treatment for cancer a composition comprising i) aspirin, methyl salicylate, diclofenac, meloxicam ibuprofen, celecoxib or naproxen in an amount of about 0.075 mg per unit dose to about 900 mg per unit dose; ii) epilactose in an amount of about 0.014 mg per unit dose to about 600 mg per unit dose; and iii) zinc in an amount of about 0.015 mg per unit dose to about 890 mg per unit dose, wherein the composition has a Synergy Index less than 1.0.