US2007098815A1PendingUtilityA1

Orally Administrable Gallium Compositions and Methods of Use

59
Individually held — no corporate assignee on recordPriority: Oct 27, 2005Filed: Oct 23, 2006Published: May 3, 2007
Est. expiryOct 27, 2025(expired)· nominal 20-yr term from priority
Inventors:Lawrence Richard Bernstein
A61P 31/04A61K 45/06A61K 9/0095A61K 31/28A61K 9/2054A61K 31/717A23V 2002/00A23L 33/16A61K 47/38A61K 9/4858A61K 9/2013A23K 20/20A61K 31/555A61K 9/4866A61K 33/242A61K 33/244A61K 33/243A61K 33/24Y02A50/30
59
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Claims

Abstract

Provided are pharmaceutical gallium compositions that are particularly useful for oral administration. The pharmaceutical compositions include solid, liquid, and paste formulations, which have high oral gallium bioavailability and are suitable for human and veterinary applications. The compositions comprise pharmaceutically acceptable gallium compounds, such as gallium maltolate, gallium 8-quinolinolonate, or gallium nitrate, together with certain viscosity-increasing agents, such as water-soluble forms of methylcellulose or carboxymethylcellulose.

Claims

exact text as granted — not AI-modified
1 . A pharmaceutical composition comprising a pharmaceutically acceptable gallium compound and a pharmaceutically acceptable viscosity-increasing agent.  
   
   
       2 . The pharmaceutical composition of  claim 1 , wherein the viscosity-increasing agent is 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.  
   
   
       3 . The pharmaceutical composition of  claim 2 , wherein the viscosity-increasing agent is methylcellulose or carboxymethylcellulose.  
   
   
       4 . The pharmaceutical composition of  claim 3 , wherein the viscosity-increasing agent is carboxymethylcellulose.  
   
   
       5 . The pharmaceutical composition of  claim 1 , wherein the viscosity-increasing agent is selected from the group consisting of viscosity-increasing forms of polyethylene glycol, Carbopols, povidones, gum Arabic, and xanthum gum.  
   
   
       6 . The pharmaceutical composition of  claim 1 , wherein the gallium compound is 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.  
   
   
       7 . The pharmaceutical composition of  claim 6 , wherein the gallium compound is gallium maltolate.  
   
   
       8 . The pharmaceutical composition of  claim 1 , comprising a solid state mixture of the gallium compound and the viscosity-increasing agent.  
   
   
       9 . The pharmaceutical composition of  claim 8 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 0.1 to 1000.  
   
   
       10 . The pharmaceutical composition of  claim 9 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 1 to 250.  
   
   
       11 . The pharmaceutical composition of  claim 8 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 10 to 100.  
   
   
       12 . The pharmaceutical composition of  claim 1 , comprising a drinkable liquid suitable for oral administration.  
   
   
       13 . The pharmaceutical composition of  claim 12 , comprising a solution, an emulsion, a gel, a sol, a suspension, or a mixture of any of the foregoing.  
   
   
       14 . The pharmaceutical composition of  claim 13 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 0.1 to 1000.  
   
   
       15 . The pharmaceutical composition of  claim 14 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 1 to 500.  
   
   
       16 . The pharmaceutical composition of  claim 15 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 20 to 200.  
   
   
       17 . The pharmaceutical composition of  claim 1 , comprising a viscous liquid or paste.  
   
   
       18 . The pharmaceutical composition of  claim 17 , comprising a solution, an emulsion, a gel, a sol, a suspension, or a mixture of any of the foregoing.  
   
   
       19 . The pharmaceutical composition of  claim 18 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 0.1 to 1000.  
   
   
       20 . The pharmaceutical composition of  claim 19 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 1 to 500.  
   
   
       21 . The pharmaceutical composition of  claim 20 , wherein the weight ratio of the gallium compound to the viscosity-increasing agent is approximately 50 to 250.  
   
   
       22 . The pharmaceutical composition of  claim 1  adapted for oral administration.  
   
   
       23 . The pharmaceutical composition of  claim 1 , further comprising means to prevent or inhibit dissociation of the gallium compound in the acidic environment of the stomach.  
   
   
       24 . The pharmaceutical composition of  claim 23 , wherein the means to prevent or inhibit dissociation of the gallium compound is selected from the group consisting of an enteric coating, a buffer, and excess ligand.  
   
   
       25 . The pharmaceutical composition of  claim 23 , wherein the means to prevent or inhibit dissociation of the gallium compound is encapsulation in liposomes.  
   
   
       26 . The pharmaceutical composition of  claim 1 , further comprising one or more additional active agents.  
   
   
       27 . The pharmaceutical composition of  claim 1 , in unit dosage form.  
   
   
       28 . The pharmaceutical composition of  claim 1 , further comprising animal feed.  
   
   
       29 . The pharmaceutical composition of  claim 28 , wherein the animal feed is horse feed.  
   
   
       30 . A solid composition derived from the evaporation of liquid from any of the compositions of claims  12  through  21 .  
   
   
       31 . A pharmaceutical formulation comprising gallium maltolate, carboxymethylcellulose, benzyl alcohol, water, and simple syrup.  
   
   
       32 . The pharmaceutical composition of  claim 31 , comprising 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.  
   
   
       33 . A method of treating or preventing a gallium-responsive disease or disorder in a human or veterinary patient, comprising administering an effective amount of the pharmaceutical composition of  claim 1 .  
   
   
       34 . The method of  claim 33 , wherein the patient is human.  
   
   
       35 . The method of  claim 33 , wherein the patient is a horse or other equid.  
   
   
       36 . The method of  claim 33 , wherein the patient is a bovine animal.

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