Medical organogel processes and compositions

Patent metadata

Field	Value
Publication number	US-11890343-B2
Application number	US-202017131242-A
Country	US
Kind code	B2
Filing date	Dec 22, 2020
Priority date	Dec 5, 2011
Publication date	Feb 6, 2024
Grant date	Feb 6, 2024

Abstract

Serial-solvent biomaterials are described. Embodiments include materials made in an organic solvent that are stripped of the solvent and used in a patient, where they imbibe water and form a hydrogel. These materials are useful for, among other things, delivering therapeutic agents, tissue augmentation, and radiological marking.

First claim

The invention claimed is:

1. A process of making a medical material comprising forming an organogel around a powder of a water soluble biologic, with the organogel comprising an organic solvent and with the powder being dispersed in the organogel, wherein the organogel comprises covalently crosslinked hydrophilic polymers and/or ionically crosslinked polymers, wherein the organogel is formed in an absence of aqueous solution.

2. The process of claim 1 wherein the water soluble biologic is a protein that has a molecular mass of at least about 10,000 Daltons and a sugar is associated with the protein.

3. The process of claim 1 wherein the powder is a first powder, with the process further comprising a second powder that comprises a second water soluble biologic agent, with the first powder and the second powder being dispersed through the organogel.

4. The process of claim 1 further comprising removing the organic solvent from the organogel to thereby form a xerogel.

5. The process of claim 4 wherein the organic solvent is removed by a process chosen from the group consisting of vacuum removal, lyophilization, and freezing followed by application of a vacuum.

6. The process of claim 4 wherein the xerogel is a hydrogel upon exposure to an aqueous solution.

7. The process of claim 6 wherein the water soluble biologic remains substantially in the powder, in a solid phase, when the hydrogel is formed, and slowly dissolve over a period of time when the hydrogel is exposed to physiological solution in vivo in a mammal.

8. The process of claim 6 wherein the water soluble biologic is a protein having a secondary and/or a tertiary structure, with the protein being released in a conformation that is substantially free of denaturation as measurable by enzyme-linked immunosorbent assay and/or isoelectric focusing.

9. The process of claim 1 , wherein the organogel comprises covalently crosslinked hydrophilic polymers.

10. The process of claim 6 , wherein the hydrogel is biodegradable by spontaneous hydrolysis of hydrolytically degradable linkages chosen from the group consisting of esters, carbonates, anhydrides and orthocarbonates.

11. The process of claim 1 wherein the organogel comprises block copolymers that form the organogel, wherein the organogel forms a xerogel upon removal of solvent, wherein the xerogel forms a hydrogel upon exposure to an aqueous solution.

12. The process of claim 1 wherein the organogel comprises a member chosen from the group consisting of alginate, gellan, collagen, and polysaccharide.

13. The process of claim 1 further comprising forming a plurality of particles out of:
the organogel, a xerogel made from the organogel, or a hydrogel made from the organogel.

14. The process of claim 1 comprising forming the organogel from a precursor in an organic solvent, with the precursor being chemically reacted to form covalent bonds to thereby form the organogel, wherein the organogel is covalently crosslinked.

15. The process of claim 14 wherein the precursor is reacted by free radical polymerization to form the organogel.

16. The process of claim 14 wherein the precursor is a first precursor comprising a first functional group and further comprising a second precursor comprising a second functional group, with the first functional group and the second functional group being reactive in the organic solvent to form the covalent bonds.

17. The process of claim 16 wherein the first functional group and the second functional group are each chosen from the group consisting of electrophile and nucleophile, and the reaction between the first functional group and second functional group is an electrophilic-nucleophilic reaction that forms the covalent bond.

18. The process of claim 17 wherein the electrophilic group comprises succimide, succinimide ester, n-hydroxysuccinimide, maleimide, succinate, nitrophenyl carbonate, aldehyde, vinylsulfone, azide, hydrazide, isocyanate, diisocyanate, tosyl, tresyl, or carbonyldiimidazole.

19. A process of making a medical material comprising
forming an organogel around a powder of a water soluble biologic, with the organogel comprising an organic solvent and with the powder being dispersed in the organogel, wherein the organogel is formed in the absence of aqueous solution; and
removing the organic solvent from the organogel to thereby form a xerogel.

Assignees

• Incept Llc

Inventors

• Jarrett Peter
• El-Hayek Rami
• Sawhney Amarpreet S

Classifications

• A61K47/34 Primary

  Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) · CPC title

• A61K9/06 Primary

  Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} · CPC title

• A61K38/38

  Albumins · CPC title

• C07K16/00

  Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies · CPC title

• A61K9/0051

  Ocular inserts or implants · CPC title