# US 12,594,239 B2 · Protection of biological species from degradation

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- Number: US 12,594,239 B2
- Document ID: US12594239B2
- Status: Granted
- Kind: B2
- Application number: 18/580,570
- Filed: 2022-07-22
- Published: 2025-07-17
- Granted: 2026-04-07
- Earliest claimed: 2021-07-23
- Assignees: Sisaf Limited
- Applicants: Sisaf Ltd
- Inventors: Roghieh Suzanne Saffie-Siebert; Flavia Sutera
- Web page: https://patentgrep.com/patent/US12594239B2

## CPC

- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/143: {with inorganic compounds}
- A61K 9/145: {with organic compounds}
- A61K 31/7105: Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
- A61K 31/713: Double-stranded nucleic acids or oligonucleotides
- A61K 47/02: Inorganic compounds
- A61K 47/36: Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K 47/38: Cellulose; Derivatives thereof
- A61K 47/544: {Phospholipids}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 39/00: Medicinal preparations containing antigens or antibodies (materials for immunoassay G01N33/53)
- C12N 15/111: {General methods applicable to biologically active non-coding nucleic acids}
- C12N 2310/14: interfering nucleic acids [NA]
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A method of preparing an injectable or oral storage stable formulation, comprising: contacting a biological species with a delivery system comprising biocompatible solid particles to form a complex; then optionally, lyophilising the complex to form a powder, and then dispersing the complex in a biodegradable gel material to form the formulation, comprising the complex embedded in the biodegradable gel material. Also related products, methods, and medical uses.

## Claims

### Claim 1

A method of preparing an injectable or oral storage stable formulation, comprising:
(i) contacting a biological species with a delivery system comprising (a) biocompatible solid particles that comprise hydrolysable silicon and (b) a lipid component comprising a cationic lipid and/or an ionisable lipid, to form a complex; then
(ii) optionally, lyophilising the complex to form a powder; and then
(iii) dispersing the complex in a biodegradable gel material to form the formulation, comprising the complex embedded in the biodegradable gel material.

### Claim 2 (depends on 1)

The method of claim 1, wherein the delivery system further comprises a non-reducing disaccharide.

### Claim 3

An injectable or oral storage stable formulation, comprising a biodegradable gel material in which is embedded a biological species complexed to a delivery system comprising biocompatible solid particles that comprise hydrolysable silicon, a lipid component comprising a cationic lipid and/or an ionisable lipid, and, optionally, a non-reducing disaccharide.

### Claim 4 (depends on 1)

An injectable or oral storage stable formulation prepared according to the method of claim 1.

### Claim 5 (depends on 3)

A method of preparing a medicament comprising a biological species for oral administration or administration by injection, the method comprising:
(i) providing a formulation in accordance with claim 3; then
(ii) optionally, storing the formulation; and then
(iii) preparing the medicament comprising the biological species and delivery system for oral administration or administration by injection,
wherein the step (iii) of preparing the medicament does not include any extraction steps, such that the medicament comprises all the constituents of the formulation.

### Claim 6 (depends on 5)

The method of claim 5 wherein in the step (ii) of storing the formulation, the formulation is stored at a temperature above 4° C. for at least 3 months.

### Claim 7 (depends on 5)

An oral or injectable medicament obtained by the method of claim 5, either
comprising: the biological species complexed with the delivery system, wherein the complex is embedded in a biodegradable gel material; or
comprising: a complex of the biological species and the delivery system, together with compounds capable of forming the matrix of a biodegradable gel dispersed in a carrier system,
wherein the delivery system comprises particles of hydrolysable silicon, a lipid component comprising a cationic lipid, and, optionally, a non-reducing disaccharide.

### Claim 8 (depends on 7)

The medicament of claim 7, wherein the medicament is in the form of an injectable solution.

### Claim 9 (depends on 7)

A method of treating or preventing a disease or disorder, the method comprising administering orally or by injection the medicament of claim 7 to a subject in need thereof.

### Claim 10

A method of protecting a biological species from degradation, comprising:
(i) contacting the biological species with a delivery system comprising (a) biocompatible solid particles that comprise hydrolysable silicon and (b) a lipid component comprising a cationic lipid and/or an ionisable lipid, to form a complex; then
(ii) optionally, lyophilising the complex to form a powder; and then
(iii) dispersing the complex in a biodegradable gel material to form an oral or injectable formulation comprising the complex embedded in the biodegradable gel material.

### Claim 11 (depends on 10)

The method of claim 10, wherein the delivery system further comprises a non-reducing disaccharide.

### Claim 12 (depends on 3)

An injection device comprising the formulation of claim 3.

### Claim 13 (depends on 3)

An oral dosage form comprising the formulation of claim 3.

### Claim 14 (depends on 3)

The formulation of claim 3, wherein the delivery system comprises the non-reducing disaccharide trehalose.

### Claim 15 (depends on 3)

The formulation of claim 3, wherein the biological species comprises one or more of: a nucleic acid, an antigen and a vaccine.

### Claim 16 (depends on 15)

The formulation of claim 15, wherein the biological species comprises RNA or plasmid DNA; and, optionally, one or more enzymes.

### Claim 17 (depends on 3)

The formulation of claim 3, wherein the lipid component further comprises a phospholipid and, optionally, a PEG-lipid and/or a structural lipid.

### Claim 18 (depends on 3)

The formulation of claim 3, wherein the delivery system comprises an amino acid.

### Claim 19 (depends on 18)

The formulation of claim 18, wherein the amino acid is selected from the group consisting of: arginine, histidine, lysine, proline and glycine.

### Claim 20 (depends on 19)

The formulation of claim 19, wherein the amino acid is glycine or a combination of glycine with arginine or lysine.

### Claim 21 (depends on 18)

The formulation of claim 18, wherein the lipid component is or comprises one or more phospholipids.

### Claim 22 (depends on 21)

The formulation of claim 21, wherein the amino acid is tyrosine.

### Claim 23 (depends on 16)

The formulation of claim 16, wherein the biological species comprises mRNA.