# US 10,245,350 B2 · Polymer-clay composite and organoclay

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- Number: US 10,245,350 B2
- Document ID: US10245350B2
- Status: Granted
- Kind: B2
- Application number: 15/306,020
- Filed: 2015-04-24
- Published: 2017-02-16
- Granted: 2019-04-02
- Earliest claimed: 2014-04-24
- Assignees: University of Southampton
- Applicants: University of Southampton
- Inventors: Richard Oreffo; Jonathan Dawson; David Gibbs; Jons Hilborn; Dmitri Ossipov
- Web page: https://patentgrep.com/patent/US10245350B2

## CPC

- A61L 27/446: {with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46}
- A61K 38/1875: {Bone morphogenic factor; Osteogenins; Osteogenic factor; Bone-inducing factor}
- A61K 47/02: Inorganic compounds
- A61L 27/52: Hydrogels or hydrocolloids
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- C08J 3/075: Macromolecular gels
- C08K 3/346: {Clay}
- C09D 5/00: Coating compositions, e.g. paints, varnishes or lacquers, characterised by their physical nature or the effects produced {(electrically insulating plastics, resins or waxes H01B3/30)}; Filling pastes
- A61L 2300/414: Growth factors
- A61L 2300/64: Animal cells
- A61L 2400/12: Nanosized materials, e.g. nanofibres, nanoparticles, nanowires, nanotubes; Nanostructured surfaces
- A61L 2430/02: for reconstruction of bones; weight-bearing implants
- C08J 2305/08: Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
- C08K 2201/006: Additives being defined by their surface area
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)
- C08J: WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H (working, e.g. shaping, of plastics B29)
- C08K: Use of inorganic or non-macromolecular organic substances as compounding ingredients (paints, inks, varnishes, dyes, polishes, adhesives C09)
- C09D: COATING COMPOSITIONS, e.g. PAINTS, VARNISHES OR LACQUERS; FILLING PASTES; CHEMICAL PAINT OR INK REMOVERS; INKS; CORRECTING FLUIDS; WOODSTAINS; PASTES OR SOLIDS FOR COLOURING OR PRINTING; USE OF MATERIALS THEREFOR (cosmetics A61K; processes for applying liquids or other fluent materials to surfaces, in general, B05D; staining wood B27K5/02; glazes or vitreous enamels C03C; natural resins, French polish, drying-oils, driers, turpentine, per se, C09F; polishing compositions other than French polish, ski waxes C09G; adhesives or use of materials as adhesives C09J; materials for sealing or packing joints or covers C09K3/10; materials for stopping leaks C09K3/12; processes for the electrolytic or electrophoretic production of coatings C25D)

## Abstract

The invention relates to a polymer-clay composite material comprising clay nanoparticles and a polymer, and wherein (a) the polymer comprises phosphate and/or phosphonate ligands; or (b) the polymer-clay composite further comprises linker molecules comprising a phosphate or phosphonate ligand, wherein the linker molecules are arranged to be anchored to the polymer. The invention further relates to organoclays, BMP-clay composite material. Uses, treatments, and manufacturer of the material are also provided.

## Claims

### Claim 1

An implantable or injectable bone morphogenic protein (BMP)-clay composite material for the promotion of bone growth in a subject comprising:
clay nanoparticles; and
BMP, wherein the BMP is provided at a concentration of between 0.5 μg/cm3 and 5 μg/cm3 of the BMP-clay composite material.

### Claim 2 (depends on 1)

The BMP-clay composite according to claim 1, further comprising a polymer to form a BMP-dosed polymer-clay composite material.

### Claim 3 (depends on 2)

The BMP-clay composite material according to claim 2, wherein the polymer comprises glycosaminoglycan.

### Claim 4 (depends on 3)

The BMP-clay composite material according to claim 3, wherein the glycosaminoglycan comprises hyaluronan (HA).

### Claim 5 (depends on 2)

The BMP-clay composite material according to claim 2, wherein the polymer comprises at least one of polyacrylamide, pectin, alginate, carboxymethylcellulose, methylcellulose, polyethylene glycol (PEG), polysaccharide, starch, cellulose, chitin, hyaluronate, protein, collagen, gelatine, casein, albumin, polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), polylactic acid (PLA), polyhydroxy acid (PHA), poly ([alpha]-hydroxyacid), poly (D, L-lactide-co-glycolide) (PLGA), poly D,L-lactic acid (PDLLA), polyethyleneimine (PEI), polyglycolic acid, poly-lactide poly-glycolide copolymer, poly-lactide poly-glycolide polyethylene glycol copolymer, polyester, poly ([epsilon]-caprolactone), poly (3-hydroxy-butyrate), poly (s-caproic acid), poly (p-dioxanone), poly (propylene fumarate), poly (orthoester), polyol/diketene acetal addition polymer, polyanhydride, poly (sebacic anhydride) (PSA), poly (carboxybiscarboxyphenoxyphosphazene) (PCPP), poly [bis(p-carboxyphenoxy) methane] (PCPM), poly (amino acids), poly (pseudo amino acids), polyphosphazene, derivative of poly [(dichloro) phosphazene], poly [(organo) phosphazene], polyphosphate, polyethylene glycol polypropylene block co-polymer, natural polymer, synthetic polymer, silk, elastin, chitosan, fibrin, fibrinogen, peptide, polypeptide, and combinations thereof.

### Claim 6 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the BMP is provided in the BMP-clay composite at a dose of 0.036 μg.

### Claim 7 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the BMP is provided in the BMP-clay composite at a dose of between 0.01 μg and 0.1 μg.

### Claim 8 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the BMP is provided at a concentration of between 0.5 μg/cm3 and 1 μg/cm3 of the BMP-clay composite material.

### Claim 9 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the BMP-clay composite material comprises between about 1% and about 7% clay nanoparticles (w/v) in a carrier suspension.

### Claim 10 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the BMP comprises at least one of BMP-2, BMP-3, BMP-4, BMP-6, BMP-7 (OP-1), BMP-8, and combinations thereof.

### Claim 11 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the BMP-clay composite material is set into a gel upon injection into a subject.

### Claim 12 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the BMP-clay composite material is in situ at a defect site and comprises further doses of exogenous BMP.

### Claim 13 (depends on 1)

The BMP-clay composite material according to claim 1, wherein the clay nanoparticles comprise synthetic hectorite.