PROCESS FOR REMOVING Pb2+ IONS FROM BODILY FLUIDS USING TITANATE-BASED ION EXCHANGERS

A method for selectively removing Pb2+ toxins from gastrointestinal fluid, the process comprising contacting the fluid containing the toxins with an alkali titanate ion exchanger, resulting in an ion exchanged ion exchanger and thereby removing the Pb2+ toxins from the fluid, the alkali titanate ion exchanger having an empirical formula on an anhydrous basis of:

• wherein
• A is an exchangeable cation selected from the group consisting of potassium ion, sodium ion, lithium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof;
• “m” is the mole ratio of A to Ti and has a value from 0.10 to 0.60;
• and “z” is the mole ratio of O to Ti and has a value from 2.05 to 2.60,
• wherein the alkali titanate ion exchanger is synthesized from a Ti source that is either nano-sized TiO2 powder or preformed spray dried TiO2 spheres, wherein the alkali titanate ion exchanger exhibits a median particle size of greater than 3 microns (μm), and wherein the alkali titanate ion exchanger minimally disrupts the levels of any one or more ions selected from Na+, Mg2+, K+, and Ca2+.

An intracorporeal process for removing Pb2+ toxins from gastrointestinal fluid, the process comprising contacting the fluid containing the toxins with an alkali titanate ion exchanger resulting in an ion exchanged ion exchanger thereby removing the toxins from the fluid, the alkali titanate ion exchanger having an empirical formula on an anhydrous basis of:

• wherein
• A is an exchangeable cation selected from the group consisting of potassium ion, sodium ion, lithium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof;
• “m” is the mole ratio of A to Ti and has a value from 0.10 to 0.60;
• and “z” is the mole ratio of O to Ti and has a value from 2.05 to 2.60, wherein the alkali titanate ion exchanger is synthesized from a Ti source that is either nano-sized TiO2 powder or preformed spray dried TiO2 spheres, and wherein the alkali titanate ion exchanger exhibits a median particle size of greater than 3 microns (μm).

A process for preparing an alkali titanate ion exchanger, the alkali titanate ion exchanger having an empirical formula on an anhydrous basis of:

• wherein
• A is an exchangeable cation selected from the group consisting of potassium ion, sodium ion, lithium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof;
• “m” is the mole ratio of A to Ti and has a value from 0.10 to 0.60;
• and “z” is the mole ratio of O to Ti and has a value from 2.05 to 2.60, wherein the titanate-based ion exchanger is synthesized from titania (TiO2) reagents, including nano-sized titania powder, preformed spray dried titania spheres, or both, the process comprising;
• (a) forming a reaction mixture comprising reactive sources of A, Ti, and water;
• and
• (b) heating the reaction mixture at a temperature of about 85° C. to about 225° C. for a time period of 0.5 to 30 days to form the alkali titanate ion exchanger;
• wherein the reaction mixture comprises a composition expressed in terms of mole ratios of the oxides of:
• wherein “p” has a value from about 4 to 40;
• and “f” has a value from 20 to 1000.

A method for manufacturing a tablet or capsule or for oral administration, the tablet or capsule comprising an alkali titanate ion exchanger having an empirical formula on an anhydrous basis of:

• wherein
• A is an exchangeable cation selected from the group consisting of potassium ion, sodium ion, lithium ion, calcium ion, magnesium ion, hydronium ion or mixtures thereof;
• “m” is the mole ratio of A to Ti and has a value from 0.10 to 0.60;
• and “z” is the mole ratio of O to Ti and has a value from 2.05 to 2.60, wherein the alkali titanate ion exchanger exhibits a median particle size of greater than 3 microns (μm),
• the method comprising:
• (a) forming a reaction mixture comprising reactive sources of A, Ti, and water,
• (b) heating the reaction mixture for a period of time to form a alkali titanate ion exchanger;
• (c) treating the synthesized alkali titanate ion exchanger via acid extraction and/or ion exchange with alkali metals, alkaline earth metals, or mixtures thereof, to form the alkali titanate ion exchanger with the desired composition;
• (d) optionally admixing the alkali titanate ion exchanger with one or more pharmaceutically acceptable adjuvants, diluents or carriers to form an alkali titanate ion exchanger medicament;
• (e) forming a capsule or tablet comprising the alkali titanate ion exchanger medicament;
• wherein the reaction mixture comprises a composition expressed in terms of mole ratios of the oxides of:
• wherein “p” has a value from about 4 to 40;
• and “f” has a value from 20 to 1000.