Clay nanoparticles for medical use

Inventors

Oreffo, Richard • Dawson, Jonathan • Mousa, Mohamed • Shaw, Allison • Janeczek, Agnieszka

Assignees

Renovos Biologics Ltd

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Publication Number

US-12036328-B1

Patent

Publication Date

2024-07-16

Expiration Date


Abstract

Compositions, processes, and methods are provided including, but not limited to, a composition including a plurality of clay nanoparticles, wherein each clay nanoparticle comprises an anionic component and a cationic component wherein the anionic component has the formula (I): [(Si8MgbLic)O20(OH)4]  (I) wherein 5.5<b≤6,and wherein c>0 and b/c>12.

Core Innovation

The invention relates to a composition comprising a plurality of clay nanoparticles. Each clay nanoparticle comprises an anionic component and a cationic component, where the anionic component has the formula (I): [(Si8MgbLic)O20(OH)4]. The anionic component is defined by constraints 5.5<b≤6, c>0, and 12<b/c≤18.

The composition can form into a gel that demonstrates a 50% change in zeta potential within a pH range of from pH 6.5 to pH 8 when zeta potential is measured using acid titration. Gelation and rheological and zeta-potential behavior are linked to the Mg/Li ratio, including behavior associated with physiological pH.

The disclosure further describes self-assembly and high stability of the resulting gel, with improved localization at physiological pH. The composition is described in formulation forms including gel/film/powder, and optional loading with therapeutic or diagnostic agents, including regenerative medicine agents such as BMPs (including BMP-2 and BMP-7) and antimicrobial agents.

Claims Coverage

The independent claim clm-00001 is directed to a gel-forming composition defined by an anionic clay nanoparticle formula (I) together with specific parameter constraints and a defined zeta-potential response over pH 6.5 to 8. The dependent claims refine the independent claim by narrowing parameter ranges, specifying the cationic component as Na+, defining additional zeta-potential/pH behavior, specifying a measurement method (ICP-OES), and specifying physical form and optional therapeutic/diagnostic agent content.

Clay nanoparticle anionic component with constrained Mg and Li ratios

A composition comprising clay nanoparticles where the anionic component has the formula (I): [(Si8MgbLic)O20(OH)4], wherein 5.5<b≤6 and c>0.

Gel-forming composition with constrained b/c ratio

The composition where 12<b/c≤18 and the composition can form into a gel.

Zeta potential response of the gel across pH 6.5 to 8

The gel demonstrates a 50% change in zeta potential within a pH range of from pH 6.5 to pH 8 when zeta potential is measured using acid titration.

Overall, the claim coverage centers on a gel-forming clay nanoparticle composition defined by the anionic component formula (I) with specified b, c, and b/c constraints, together with a specified 50% zeta-potential change across pH 6.5 to 8 under acid titration measurement. Dependent claim refinements in the provided content include specific tightening of parameter ranges, cation selection as Na+, additional pH window constraints for zeta-potential behavior, ICP-OES measurement of Mg and Li, and optional inclusion of therapeutic/diagnostic agents such as BMP-2 and antimicrobial agents.

Stated Advantages

Self-assemble and exhibit high stability.

Improved localization at physiological pH.

Documented Applications

Therapeutic use described for regenerative medicine, including tissue repair/regeneration and cell delivery, using therapeutic agents including BMPs (including BMP-2 and BMP-7).

Infection treatment and prevention using antimicrobial agents.

Cosmetic use as a topical gel or cream and/or tissue filler.

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