Mouthwash compositions

A concentrate formulation which upon dilution with water forms a solution that is effective for use as a dental rinse or mouthwash and which comprises:

• (a) a calcium concentrate which itself comprises an aqueous solution of calcium ions and stabilising agent;
• and, associated therewith but separate therefrom,
• (b) A phosphate concentrate which itself comprises an aqueous solution of phosphate ions and stabilising agent;
• wherein the stabilizing agents referred to in paragraphs (a) and (b) hereof are selected from the group of one or more salts of cations Na+, K+, NH4+, Mg++ and Sr++ and the anions Cl−, CO3−, HCO3−, and NO3−, wherein the calcium and phosphate ions and stabilising agents are present in such amounts whereby, on diluting each concentrate (a) and (b) with water and thereafter mixing the two stock solutions (a) and (b) thereby formed, there is formed a solution which is supersaturated with respect to calcium phosphates, which has a pH in the range of from about 5 to about 8, and which is substantially free from carbon dioxide, alcohol, silicate, acetate or other organic acid salt, chelating agent, antinucleating agent, and fluorophosphate, and which remains so for at least 1 minute at body temperature.

A method of preparing a solution supersaturated with respect to calcium and phosphate(s) for use as an oral rinse, which solution comprises:

• calcium ions in a concentration in the range of from about 2 to about 40 mM;
• (ortho)phosphate ions in a concentration in the range of from about 0.5 to about 32 mM;
• and
• sodium ions in a concentration in the range of from 0 to about 0.5M which method comprises mixing:
• (a) a calcium stock solution comprising from 4 to about 80 mM calcium ions and from about 0 to about 400 mM sodium chloride;
• and (b) a phosphate stock solution comprising from about 1 to about 64 mM (ortho)phosphates and from about 0 to about 40 mM sodium chloride to form said supersaturated solution.

A formulation which is effective for use as a dental rinse or mouthwash and which formulation is a supersaturated solution of calcium phosphates that has a pH of from about 5 to about 8, that is substantially free from carbon dioxide, alcohol, silicate, acetate or other organic acid salt, chelating agent, antinucleating agent, and fluorophosphate, and that is formed by mixing:

• (a) a calcium stock solution comprising an aqueous solution of calcium ions and a physiologically acceptable first stabilising agent;
• and
• (b) a phosphate stock solution comprising an aqueous solution of phosphate ions and a physiologically acceptable second stabilising agent,
• wherein each of said first and second stabilising agents is selected from the groups of one or more salts of the cations Na+, K+, NH4+, Mg++ and Sr++ and the anions Cl−, CO3=, HCO3−, and NO3−, wherein the calcium ions in the calcium stock solution and the phosphate ions in the phosphate stock solution are present in amounts sufficient to form, on mixing and prior to use, a solution which is supersaturated with respect to calcium phosphate(s) and which contains enough of said first and second stabilising agents to remain supersaturated for at least one minute at body temperature.

A method for the treatment or prevention of a condition of the hard tissue of the oral cavity by administering to a patient in need thereof a supersaturated solution of calcium ions and phosphate ions and which has been prepared by mixing:

• (a) a calcium stock solution comprising an aqueous solution of calcium ions and a physiologically acceptable first stabilising agent;
• and
• (b) a phosphate stock solution comprising an aqueous solution of phosphate ions and a physiologically acceptable second stabilising agent;
• wherein each of said first and second stabilising agents is selected from the group of one or more salts of the cations Na+, K+, NH4+, Mg++ and Sr++ and the anions Cl−, CO3=, HCO3−, and NO3−, wherein the calcium ions in the calcium stock solution and the phosphate ions in the phosphate, stock solution are present in amounts sufficient to form, on mixing and prior to use, a solution which is supersaturated with respect to calcium ions and phosphate ions, which has a pH in the range of from about 5 to about 8, which contains enough of said first and second stabilising agents to remain supersaturated for at least one minute at body temperature, and which is substantially free from carbon dioxide, alcohol, silicate, acetate or other organic acid salt, chelating agent, antinucleating agent, and fluorophosphate.

A pack for use by or with a patient who is in need of treatment involving remineralisation of the oral cavity, the pack comprising:

• (a) a calcium stock solution or a concentrate therefor comprising an aqueous solution of calcium ions and stabilising agent;
• (b) a phosphate stock solution or a concentrate therefor comprising an aqueous solution of phosphate ions and stabilising agent;
• (c) instructions for mixing said stock solutions (a) and (b) to form a supersaturated solution of calcium and phosphate ions and for administering said supersaturated solution to said patient,
• wherein the stabilising agents refered to in paragraphs (a) and (b) hereof are selected from the group of one or more salts of the cations Na+, K+, NH4+, Mg++ and Sr++ and the anions Cl−, CO3=, HCO3−, and NO3−, wherein the calcium ions in the calcium stock solution or concentrate and the phosphate ions in the phosphate stock solution or concentrate are present in amounts sufficient to form, on mixing and prior to use, a solution which has a pH in the range from about 5 to about 8, which is supersaturated with respect to calcium and phosphate ions, which contains enough of the stabilising agents to remain supersaturated for at least 1 minute at body temperature, and which is substantially free from carbon dioxide, alcohol, silicate, acetate or other organic acid salt, chelating agent, antinucleating agent, and fluorophosphate.