# US 12,214,046 B2 · Protein-loaded PLGA nanospheres

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- Number: US 12,214,046 B2
- Document ID: US12214046B2
- Status: Granted
- Kind: B2
- Application number: 17/830,615
- Filed: 2022-06-02
- Published: 2023-03-09
- Granted: 2025-02-04
- Earliest claimed: 2019-12-05
- Assignees: West Virginia University Board of Governors on behalf of West Virginia University
- Applicants: West Virginia University Board of Governors on behalf of West Virginia University
- Inventors: Brock A Lindsey; Justin E Markel; Ryan A Lacinski; Jabeen Noore
- Web page: https://patentgrep.com/patent/US12214046B2

## CPC

- A61K 47/62: the modifying agent being a protein, peptide or polyamino acid
- A61K 9/5153: {Polyesters, e.g. poly(lactide-co-glycolide)}
- A61K 9/5192: {Processes}
- A61K 31/43: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems
- A61K 31/7036: having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
- A61K 38/208: {IL-12}
- 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)

## Abstract

The present disclosure provides compositions comprising protein encapsulated nanoparticles, and methods of making said compositions. In an aspect, a composition may comprise a drug delivery vector and a therapeutic substance, wherein the composition elutes at least 1.0 pg of the therapeutic substance per 100,000 particles of the drug delivery vector over a period of time under conditions of a drug delivery vector release buffer, wherein the therapeutic substance, drug delivery vector and drug delivery vector release buffer comprise a solution, wherein the solution is centrifuged and a portion stored at about 1 to 10° C., and wherein the elution of the therapeutic substance is determined by ELISA assay. This disclosure further describes a method of controlling an immunophenotype in a patient suffering from a disease which impacts the immune system.

## Claims

### Claim 1

A PLGA nanosphere prepared by
a) forming a first emulsion comprising i) PLGA comprising from 50% to 90% lactide, ii) a sorbitan fatty acid ester, iii) an organic solvent, and iv) a first aqueous phase comprising A) IL-12 and B) a species-specific whole serum, a species-specific engineered serum albumin, or a species-specific native serum albumin;
b) forming a second emulsion comprising i) the first emulsion and ii) a second aqueous phase comprising A) polyvinyl alcohol (PVA) and B) a polyoxyethylene sorbitan fatty acid ester; and
c) evaporating the organic solvent from the second emulsion, thereby forming the PLGA nanosphere.

### Claim 2 (depends on 1)

The nanosphere of claim 1, wherein the polyoxyethylene sorbitan fatty acid ester comprises polyoxyethylene sorbitan monooleate and the sorbitan fatty acid ester comprises sorbitan monostearate.

### Claim 3 (depends on 1)

The nanosphere of claim 1, where the first emulsion comprises the species-specific native serum albumin.

### Claim 4 (depends on 1)

The nanosphere of claim 1, wherein the PLGA comprises from 50% to 75% lactide.

### Claim 5 (depends on 1)

The nanosphere of claim 1, wherein the PLGA comprises 50% lactide.

### Claim 6 (depends on 1)

A dosage form, comprising the nanosphere of claim 1 and a pharmaceutically acceptable excipient.