Liquid concentrates of calcium and magnesium

Inventors

Nelson, Deanna J.

Assignees

BioLink Life Sciences Inc

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Publication Number

US-12251400-B2

Patent

Publication Date

2025-03-18

Expiration Date


Abstract

The present invention relates to a liquid concentrate of calcium propionate and a magnesium salt, optionally with sweetener, taste-masking agent, flavoring, and thickening agent. Also provided is a method for binding phosphorus in ingesta, and inhibiting absorption of phosphorus from the gastrointestinal tract of a subject by administering to the subject a liquid concentrate of at least calcium salt and magnesium salt.

Core Innovation

The invention relates to aqueous liquid concentrates and oral aqueous solutions that include calcium propionate and a magnesium salt, including calcium propionate and magnesium lactate, magnesium L-lactate, magnesium propionate, magnesium threonate, magnesium butyrate, or magnesium theanate. The compositions are formulated as an aqueous solution having specified pH, specified calcium propionate and magnesium salt molar concentrations, and a defined molar ratio from 1.5:1 to 1:1.5, and are administered orally to bind phosphorus within the gastrointestinal tract of a subject in need thereof.

The invention further addresses the treatment of hyperphosphatemia by binding phosphorus in GI contents to inhibit phosphate absorption. The compositions are described as effective at treating a subject in need thereof for hyperphosphatemia, including dialysis patients, and are positioned as alternatives to calcium acetate liquids while providing phosphorus binding within the gastrointestinal tract and enabling oral administration in liquid form.

The invention also includes optional co-formulated vitamins, including vitamin K2 and vitamin D3, with specified per-milliliter microgram and International Unit ranges. In a related aspect, the invention targets reduction of pill burden by providing an oral liquid concentrate comprising calcium magnesium propionate with specified calcium and magnesium amounts per 5 mL and a defined pH range, and by administering the concentrate effectively to treat hyperphosphatemia.

Claims Coverage

The patent includes six independent claims covering multiple aspects: phosphorus binding by orally administering a specific calcium propionate/magnesium salt liquid concentrate, providing calcium and magnesium as oral liquids by dissolving specified salts and adjusting pH, providing oral aqueous solutions effective for treating a subject using calcium magnesium propionate compositions, and reducing pill burden for hyperphosphatemic subjects using specified per-5 mL calcium-magnesium calcium magnesium propionate liquid concentrates. Across these independent claims, the main inventive features center on specified salt identity/combination, specified molar concentrations, specified calcium-to-magnesium molar ratios, and specified pH ranges, with additional vitamin co-formulation appearing in dependent claim sets.

Oral phosphorus binding liquid concentrate of calcium propionate and magnesium salt with defined molar ratio and pH

Orally administering a liquid concentrate comprising an aqueous solution of calcium propionate and a magnesium salt in a molar ratio of from 1.5:1 to 1:1.5, wherein the calcium propionate concentration is from 0.175 to 0.375 molar, the magnesium salt concentration is from 0.15 to 0.35 molar, the pH is in the range from pH 5 to pH 7.5, and the magnesium salt is selected from magnesium lactate, magnesium L-lactate, magnesium propionate, magnesium threonate, magnesium butyrate, and magnesium theanate.

Oral calcium and magnesium concentrate by dissolving calcium propionate and magnesium propionate and adjusting pH

Providing an oral liquid by dissolving calcium propionate and magnesium propionate in water to provide an aqueous solution wherein the calcium propionate concentration is from 0.175 to 0.375 molar, the magnesium propionate concentration is from 0.15 to 0.35 molar, the molar ratio of calcium propionate:magnesium propionate is from 1.5:1 to 1:1.5, and adjusting the pH of the resulting concentrate into the range from pH 5 to pH 7.5.

Oral aqueous solution effective for treating a subject with calcium magnesium propionate concentration and calcium-to-magnesium molar ratio

Providing an oral aqueous solution effective at treating a subject comprising calcium magnesium propionate wherein the calcium magnesium propionate concentration is from 0.175 to 0.375 molar, the pH is from pH 5 to pH 7.5, and the molar ratio of calcium to magnesium in the salt is in a range from 1:2 to 2:1.

Reducing pill burden of a hyperphosphatemic subject with an oral calcium magnesium propionate concentrate per 5 mL and defined pH

Reducing pill burden of a hyperphosphatemic subject by orally administering a liquid concentrate comprising an aqueous solution of from about 1.5 to 3.5 mmol calcium magnesium propionate in each 5 mL of said aqueous solution, said aqueous solution having a pH of from 5 to 7.5, wherein the method is effective at treating hyperphosphatemia.

Oral liquid concentrate by dissolving calcium magnesium propionate and adjusting pH to provide calcium and magnesium

Providing to a subject in need thereof calcium and magnesium as an oral liquid concentrate by dissolving calcium magnesium propionate in water to provide an aqueous solution comprising from 0.15 to 0.35 molar calcium magnesium propionate and adjusting the pH of the resulting concentrate into the range from pH 5 to pH 7.5.

Oral aqueous solution effective for treating a subject with calcium magnesium propionate per 5 mL and defined pH

Providing an oral aqueous solution effective at treating a subject in need thereof comprising 1.5 to 3.5 mmol calcium magnesium propionate in each 5 mL of said aqueous solution, said aqueous solution having a pH of from 5 to 7.5.

Across the independent claims, the invention is directed to orally administered aqueous liquid concentrates or oral aqueous solutions that include calcium propionate and a magnesium salt, or calcium magnesium propionate, formulated with defined molar concentrations, defined calcium-to-magnesium molar ratios, and pH in the range from pH 5 to pH 7.5. The independent claims collectively cover phosphorus binding within the gastrointestinal tract, treating hyperphosphatemia, and reducing pill burden, with dependent claim sets further refining composition targets and adding vitamin K2 and vitamin D3.

Stated Advantages

Palatability.

Small-volume dosing.

Reduced pill burden.

Reduced hypercalcemia/vascular calcification risk.

Compatibility with achlorhydric patients.

Inclusion of vitamins D3 and K2 to support beneficial enzyme activity.

Documented Applications

Binding phosphorus within the gastrointestinal tract of a subject in need thereof, to inhibit phosphate absorption.

Treating hyperphosphatemia, including use in hyperphosphatemic dialysis patients.

Reducing the pill burden of a hyperphosphatemic subject by orally administering the specified liquid concentrate.

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