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Orally administrable gallium compositions and methods of useRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Inorganic Active Ingredient Containing, Heavy Metal Or Compound ThereofOrally administrable gallium compositions and methods of use description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070098815, Orally administrable gallium compositions and methods of use. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED PATENT APPLICATIONS [0001] This application claims priority under 35 U.S.C. .sctn. 119(e) to U.S. Provisional Application No. 60/730,696, filed on Oct. 27, 2005, which is incorporated by reference in its entirety herein. TECHNICAL FIELD [0002] This invention relates generally to pharmaceutical compositions comprising gallium. More specifically, this invention relates to the preparation and use of orally administrable gallium pharmaceutical compositions comprising a pharmaceutically acceptable gallium compound, such as for example, gallium maltolate, gallium 8-quinolinolonate, or gallium nitrate, and a viscosity-increasing agent, such as for example, methylcellulose or carboxymethylcellulose. BACKGROUND OF THE INVENTION [0003] Gallium is used therapeutically and diagnostically in the management and treatment of cancer, infectious disease, inflammatory disease, bone disease, autoimmune disease, and other diseases and disorders. The administration of gallium orally, as compared to administration intravenously or by injection, provides advantages to the patient in terms of convenience, cost, safety, and possibly efficacy. [0004] Most gallium compounds are poorly absorbed when taken orally. A few compounds, including gallium maltolate and gallium 8-quinolinolate, have oral gallium bioavailabilities significantly higher than those of other gallium compounds. Gallium bioavailabilities from these compounds may not, however, always be consistent, and, because the gallium compounds may be acid labile, protection from stomach acid may be needed in some cases. SUMMARY OF THE INVENTION [0005] With the present invention, the inventor has unexpectedly and surprisingly found that the combination of a pharmaceutically acceptable gallium compound, such as for example, gallium maltolate, with a viscosity-increasing agent, such as for example, methylcellulose or carboxymethylcellulose, can increase the oral bioavailability of gallium. [0006] In a first embodiment of the invention, there is provided a pharmaceutical composition comprising a pharmaceutically acceptable gallium compound and a pharmaceutically acceptable viscosity-increasing agent. [0007] In another embodiment of the invention, there is provided a pharmaceutical composition comprising a pharmaceutically acceptable gallium compound in the solid state, preferably gallium maltolate, mixed with a viscosity-increasing agent, preferably methylcellulose or carboxymethylcellulose, in the solid state. [0008] In a further embodiment of the invention, there is provided a the pharmaceutical composition comprising a drinkable liquid suitable for oral administration (which may be a solution, an emulsion, a gel, a sol, a suspension, or a mixture of these) comprising water with dissolved and/or suspended gallium compound, preferably gallium maltolate, and dissolved and/or suspended viscosity-increasing agent, preferably methylcellulose or carboxymethylcellulose. [0009] In another embodiment of the invention, the pharmaceutical composition of the invention comprises a viscous liquid or paste (which may be a solution, an emulsion, a gel, a sol, a suspension, or a mixture of these) comprising water with dissolved and/or suspended gallium compound, preferably gallium maltolate, and dissolved and/or suspended viscosity-increasing agent, preferably methylcellulose or carboxymethylcellulose. [0010] The solid obtained by evaporation of any of the preceding liquid or partially liquid formulations of the invention is a pharmaceutical composition comprised by an additional embodiment of the invention. [0011] In another embodiment of the invention, the pharmaceutical composition of the invention comprises animal feed to which has been added any of the preceding liquid, partially liquid, viscous liquid, paste, solid, or other formulations of the invention. [0012] In a further embodiment of the invention, there is provided a method of treating or preventing a gallium-responsive disease or disorder in a human or veterinary patient, comprising administering a therapeutically effective amount of the gallium pharmaceutical compositions of the present invention. [0013] In each of the foregoing embodiments, the pharmaceutical composition is preferably adapted for oral administration. In each embodiment, the pharmaceutical compositions may further comprise one or more additional active agents. [0014] The viscosity-increasing agent of each embodiment may be selected from the group consisting of viscosity-increasing forms of methylcellulose, carboxymethylcellulose, hydroxypropyl methylcellulose, and other cellulose derivatives, including their pharmaceutically acceptable salts, esters, hydrates, and solvates, or from the group consisting of viscosity-increasing forms of polyethylene glycol, Carbopols, povidones, gum Arabic, and xanthum gum. [0015] The gallium compound of each embodiment may be selected from the group consisting of gallium nitrate, gallium sulfate, gallium chloride, gallium citrate, gallium acetate, gallium tartrate, gallium gluconate, gallium palmitate, gallium succinate, gallium maltolate, gallium ethyl maltolate, gallium pyridinones, gallium 8-quinolinolate, gallium protoporphyrin IX, gallium pyridoxal isonicotinoyl hydrazone, and bis(2-acetylpyridine 4N-dimethylthiosemicarbazone) gallium(III), gallium(III) tetrachloride. [0016] When the pharmaceutical composition is a solid state mixture of the gallium compound and the viscosity-increasing agent, the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 0.1 to 1000, with a preferred weight ratio of the gallium compound to the viscosity-increasing agent of approximately 1 to 250, and a more preferred weight ratio of the gallium compound to the viscosity-increasing agent of approximately 10 to 100. [0017] When the pharmaceutical composition is a drinkable liquid suitable for oral administration, such as a drinkable solution, an emulsion, a gel, a sol, a suspension, or a mixture of any of the foregoing, the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 0.1 to 1000, with a preferred weight ration of the gallium compound to the viscosity-increasing agent of 1 to 500, and a more preferred weight ratio of the gallium compound to the viscosity-increasing agent of approximately 20 to 200. [0018] When the pharmaceutical composition is a viscous liquid or paste, such as an emulsion, a gel, a sol, a suspension, or a mixture of any of the foregoing, the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 0.1 to 1000, with a preferred weight ratio of the gallium compound to the viscosity-increasing agent of approximately 1 to 500, and a more preferred weight ratio of the gallium compound to the viscosity-increasing agent is approximately 50 to 250. A preferred viscous liquid or paste formulation of the invention comprises 1 to 20% w/v gallium maltolate, 10 to 30% v/v simple syrup, 0.1 to 4% v/v benzyl alcohol, 0.5 to 2.5% w/v carboxymethylcellulose, and a balance of water. [0019] The pharmaceutical composition of each embodiment may further comprise means to prevent or inhibit dissociation of the gallium compound in the acidic environment of the stomach. Such means may be selected from the group consisting of an enteric coating, a buffer, and excess ligand, or means wherein the gallium compound is encapsulated in liposomes. [0020] The pharmaceutical compositions of each embodiment may be in a unit dosage form or in divided or multiple dosage forms. Continue reading about Orally administrable gallium compositions and methods of use... Full patent description for Orally administrable gallium compositions and methods of use Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Orally administrable gallium compositions and methods of use 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. 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