ES2544960T3 - Materials of poly oxo-hydroxy metal ion modified with ligand, its uses and processes for its preparation - Google Patents

Abstract

A process for producing a solid ligand-modified metal ion poly-oxo-hydroxy material comprising metal ions (M), ligands (L), and oxo or hydroxy groups (OH), wherein: M represents one or more selected metal ions between Ag2 +, Al3 +, Au3 +, Be2 +, Ca2 +, Co2 +, Cr3 +, Cu2 +, Eu3 +, Fe3 +, Mg2 +, Mn2 +, Ni2 +, Sr2 +, V5 +, Zn2 + and Zr2 +, L represents one or more ligands that comprise a ligand selected from a carboxylic acid , maltol, ethyl maltol, vanillin, bicarbonate, sulfate, phosphate, silicate, borate, molybdate, selenate, tryptophan, glutamine, proline, valine, histidine, folate, ascorbate, pyridoxine, niacin, adipate, acetate, glutarate, dimethyl glutarate, pimelate, succinate, benzoate and propionate, and wherein the material has a polymeric structure in which the ligands are non-stoichiometrically substituted for the oxo or hydroxy groups and are distributed within the solid phase structure of the oxo-hydroxy material metallic and so that the substitution of the oxo or hydroxy groups by the ligands is basically random; wherein at least some of the ligands are integrated into the solid phase such that it exhibits formal ML bond formation that can be detected by physicoanalytical techniques and the total ligand-modified polyo-hydroxy metal ion solid material has one or more reproducible physicochemical properties, process comprising: (a) mixing metal ions M and ligands L at a first pH (A) in which the components are soluble; (b) changing the pH (A) to a second pH (B) to cause a solid precipitate to form of the solid ligand-modified poly-oxo-hydroxy metal ion material; and (c) separating, and optionally drying, the solid ligand-modified poly-oxo-hydroxy metal ion material produced in step (b).

Description

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E08709331

08-10-2015

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Ligand modified poly oxo-hydroxyl materials can be used as supplements for nutritional or medical benefit. In this area, there are three main examples:

(i)

Therapeutic supplements (with prescription), which are usually administered orally or i.v. for the treatment of indications that include iron deficiency anemia, iron deficiency and chronic disease anemia. The therapeutic administration of materials of the present invention may be in conjunction with other therapies and especially with the simultaneous use of erythropoietin.

(ii)

Nutritional (self-written / purchased supplements) that are normally for oral administration.

(iii) Strengthening agents. These can be traditional forms - in terms of their addition to the food prior to acquisition - or forms of more recent strengthening agents such as 'Dusting substances' that are added (such as salt or pepper) to the food at the time of ingestion .

In all formats, but most especially for strengthening agents, subsequent formulation, such as the addition of a protective coating (for example, lipid), may be necessary to make the material compatible with its intended use. In addition, any of these forms of supplements can be co-formulated, by incorporation into the material through the use of the co-formulated material or materials as ligand or ligands or through entrapment / encapsulation of said materials, or simply through co-administration of said materials. .

As described herein, a particular application of the ligand modified metal poly oxo-hydroxy ion solid materials of the present invention is for the treatment of mineral deficiencies, for example iron deficiency. In an alternative application, the materials can be used to join or sequester a component present in an individual. By way of example, the ferric iron compositions disclosed herein can be used to administer iron to an individual for use in the prophylaxis or treatment of iron deficiency or iron deficiency anemia of the suspected peseta iron, or diagnose through conventional hematological and clinical chemistry techniques. Iron deficiency in iron deficiency anemia can occur in isolation, for example due to inadequate nutrition or due to excessive iron losses, or they can be associated with tensions such as pregnancy or lactation, or they can be associated with diseases such as inflammatory disorders, cancers and kidney failure. In addition, there is evidence that reduced erythropoiesis associated with anemia of chronic diseases can be improved or corrected by effective administration of systemic iron and co-administration of iron with erythropoietin and its analogues may be especially effective in overcoming reduced erythropoietic activity. Therefore, by way of further example, the ferric iron compositions disclosed herein can be used to administer iron to an individual for use in the treatment of suboptimal erythropoietic activity such as in anemia of chronic diseases. Anemia of chronic diseases can be associated with conditions such as kidney failure, cancer and inflammatory disorders. As indicated above, iron deficiency can also occur normally in these disorders so it follows that a treatment through iron supplements can only treat iron deficiency and / or anemia of chronic diseases. Those skilled in the art will recognize that the above-mentioned examples of the medical uses of iron supplements are not limiting in any way.

Experimental Description

Introduction

Materials based on inorganic minerals have broad biological applications that include: dietary supplements, phosphate binding agents, antacids, immune adjuvants (alum) and antiperspirants (alum). Often these are co-formulated in such a way that the physicochemical properties of the mineral, such as dissolution and / or disaggregation rates, are modestly altered in an attempt to increase its effectiveness. However, the inventors have discovered a process through which the actual structure, at the level of the primary particle (the primary unit within the structure of the crystalline lattice), can be modified within oxide / hydroxide minerals. This formation of nanostructures can lead to profound changes in the characteristics of the mineral and can be improved to provide minerals with specifically specified physicochemical characteristics. In addition, the methodology is cheap and can be applied on a large scale if necessary. All modifying agents are biologically compatible food grade ligands that allow the rapid introduction of new human subject materials. An example of these materials is the production of a new class of iron supplements that can have therapeutic applications parenterally and orally, as well as extended roles as strengthening agents and dietary supplements.

With supplements, the inventors believe that a desirable property is that the nutrient absorption rate is mimicked to that observed for the same nutrient when ingested in a food. For example, with iron, the rate of iron absorption in the diet can be controlled through the rate of iron dissolution. In the following

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Claims (1)

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