# US 12,213,993 B2 · Coated medicinal clay compositions, pharmaceutical compositions, and delivery of cation sources and methods of use thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,213,993 B2 - Document ID: US12213993B2 - Status: Granted - Kind: B2 - Application number: 18/049,095 - Filed: 2022-10-24 - Published: 2023-04-27 - Granted: 2025-02-04 - Earliest claimed: 2021-10-25 - Assignees: Darlene E. McCord - Applicants: Darlene E. McCord - Inventors: Darlene E. McCord; Alex Hovey - Web page: https://patentgrep.com/patent/US12213993B2 ## CPC - A61K 33/26: Iron; Compounds thereof - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 9/501: {Inorganic compounds} - A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay} - A61K 33/24: Heavy metals; Compounds thereof - A61K 33/30: Zinc; Compounds thereof - A61K 33/34: Copper; Compounds thereof - A61K 33/38: Silver; Compounds thereof - A61K 33/42: Phosphorus; Compounds thereof - A61P 31/04: Antibacterial agents - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract Medicinal clay compositions and pharmaceutical compositions containing the same are disclosed. The medicinal clay compositions provide a protective barrier for the clay allowing manufacturing, storage and use that protects the medicinal clay from moisture and hydration that would otherwise prematurely activate the clay. The medicinal clay compositions allow use of medicinal clays in various delivery systems and types of therapeutic compositions, including foams, hydrocolloids, electrospinning, films, pastes, and the like. Methods of preparing the medicinal clay compositions and methods of use are also disclosed. Methods of using the medicinal clay compositions, pharmaceutical compositions, and cation sources to reduce microbial populations on a subject and/or remove chloride from exudate from a tissue or organ in need of treatment are also disclosed. ## Claims ### Claim 1 A method of treatment of a subject with a composition comprising: administering to a tissue, organ, or wound optionally wherein the tissue, organ, or wound comprises exudate comprising exudate therefrom of a subject in need of treatment a medicinal clay composition and at least one coating agent surrounding the medicinal clay composition, wherein the medicinal clay composition comprises a cation source and has a Cation Exchange Capacity of at least about greater than about 10 mEq/100 g, an Oxidation-Reduction Potential greater than about 250 mV, a pH less than about 5.0, a crystalline composition comprising smectite, illite, and/or illite-smectite that is at least about 40 wt-% of the medicinal clay composition, and less than 40 ppm heavy metal contaminants, and wherein the at least one coating agent comprises a nonionic block Ethylene oxide-propylene oxide (EO-PO) copolymer with an average molecular weight of from about 5,000 to about 20,000, wherein said coating agent prevents the premature activation of the medicinal clay composition by surrounding the medicinal clay composition, wherein the medicinal clay is activated upon contacting a water source, wherein the medicinal clay composition reduces the pH of the tissue or organ to less than about 4 to promote healing, and reducing microbial populations on the subject and/or removing exudate from the tissue, organ, or wound in need of treatment. ### Claim 2 (depends on 1) The method of claim 1, wherein the microbial populations comprise a biofilm. ### Claim 3 (depends on 1) The method of claim 1, wherein the composition is administered to a wound. ### Claim 4 (depends on 1) The method of claim 1, wherein the tissue or organ is skin, mucosal cells, intestinal track, ear canal, nasal passages or oral cavities in need of treatment thereof. ### Claim 5 (depends on 1) The method of claim 1, wherein the method reduces an alkaline pH of tissue, organ, or wound in need of treatment. ### Claim 6 (depends on 1) The method of claim 1, wherein the water source is wound exudate. ### Claim 7 (depends on 1) The method of claim 1, wherein the cation source is selected from the group consisting of Fe2+, Fe3+, Al3+ and combinations thereof to reduce microbial populations by damaging the membranes of the pathogens. ### Claim 8 (depends on 7) The method of claim 7, wherein excess solubilized cations cause intracellular protein damage through oxidation. ### Claim 9 (depends on 7) The method of claim 7, wherein the tissue or organ of a subject in need of treatment is remineralized by the cation source. ### Claim 10 (depends on 1) The method of claim 1, wherein the medicinal clay composition further comprises a therapeutic agent. ### Claim 11 (depends on 10) The method of claim 10, wherein the therapeutic agent is silver and/or silver ions (Ag+). ### Claim 12 (depends on 1) The method of claim 1, wherein the exudate removed from the wound comprises oils, secretions, toxins, and other contaminants. ### Claim 13 (depends on 1) The method of claim 1, wherein the cation source is selected from the group consisting of Fe2+, Fe3+, Al3+ and combinations thereof. ### Claim 14 (depends on 11) The method of claim 11, wherein the cation source chelates chloride anions of the wound exudate maintaining silver cation availability for therapeutic efficacy. ### Claim 15 (depends on 13) The method of claim 13, wherein the cation source is provided to the tissue, organ, or wound at a minimum effective amount based on about a 1 square inch surface of the tissue or organ of the subject in need of treatment in the amount of from about 0.00001 g and about 10.0 g. ### Claim 16 (depends on 1) The method of claim 1, wherein the cation source is administered at least daily or at least weekly to the subject. ### Claim 17 (depends on 14) The method of claim 14, wherein the cation source chelates chloride of the wound exudate maintaining silver cation availability for therapeutic efficacy. ### Claim 18 (depends on 1) The method of claim 1, wherein the at least one coating agent surrounding the medicinal clay composition has a thickness of at least about 5 microns and wherein the average particle size of the clay is less than about 250 microns in diameter. ### Claim 19 (depends on 1) The method of claim 1, wherein the medical clay composition is a crystalline composition comprising a 2:1 tetrahedral/octahedral phyllosilicate with reduced iron octahedral and exchangeable cations, and/or at least 1 wt-% pyrite. ### Claim 20 A method of treatment of a subject with a composition comprising: administering to a tissue, organ, or wound optionally wherein the tissue, organ, or wound comprises exudate comprising exudate therefrom of a subject in need of treatment a medicinal clay composition and at least one coating agent surrounding the medicinal clay composition, wherein the medicinal clay composition comprises a cation source and has a Cation Exchange Capacity of at least about greater than about 10 mEq/100 g, an Oxidation-Reduction Potential greater than about 250 mV, a pH less than about 5.0, a crystalline composition comprising smectite, illite, and/or illite-smectite that is at least about 40 wt-% of the medicinal clay composition, and less than 40 ppm heavy metal contaminants, and wherein the at least one coating agent comprises a nonionic block Ethylene oxide-propylene oxide (EO-PO) copolymer with an average molecular weight of from about 5,000 to about 20,000, wherein said coating agent prevents the premature activation of the medicinal clay composition by surrounding the medicinal clay composition, wherein the medicinal clay is activated upon contacting a water source, wherein the medicinal clay composition reduces the pH of the tissue, organ, or wound to less than about 4 to promote healing, and removing biofilm on the subject and/or from the tissue, organ, or wound in need of treatment. ### Claim 21 (depends on 20) The method of claim 20, wherein the medical clay composition is a crystalline composition comprising a 2:1 tetrahedral/octahedral phyllosilicate with reduced iron octahedral and exchangeable cations, and/or at least 1 wt-% pyrite.