# US 11,998,572 B2 · Method for treating nociceptive pain and burns with brazilian green propolis alcohol extract

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- Number: US 11,998,572 B2
- Document ID: US11998572B2
- Status: Granted
- Kind: B2
- Application number: 17/362,083
- Filed: 2021-06-29
- Published: 2022-12-29
- Granted: 2024-06-04
- Earliest claimed: 2021-06-29
- Assignees: Imam Abdulrahman Bin Faisal University
- Applicants: Imam Abdulrahman Bin Faisal University
- Inventors: Mohammed Taha Ali Al-Hariri; Turki Saeed Mohammed Abualait
- Web page: https://patentgrep.com/patent/US11998572B2

## CPC

- A61K 35/644: Beeswax; Propolis; Royal jelly; Honey
- A61K 9/7007: {Drug-containing films, membranes or sheets (A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence)}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61N 5/0616: {Skin treatment other than tanning}
- A61P 29/02: without antiinflammatory effect
- A61K 2236/333: using mixed solvents, e.g. 70% EtOH
- A61K 2236/35: Extraction with lipophilic solvents, e.g. Hexane or petrol ether
- A61N 5/062: {Photodynamic therapy, i.e. excitation of an agent}
- A61N 5/0622: {Optical stimulation for exciting neural tissue}
- A61N 2005/0661: {ultraviolet}
- 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)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A method for treating or preventing nociceptive pain by administering an ethanol extract of Brazilian green propolis and compositions comprising this extract to a site subject to or at risk of thermal injury or a burn.

## Claims

### Claim 1

A method for treating nociceptive pain from a burn, comprising:
administering to a subject in need of treatment for nociceptive pain from a burn afferently transmitted via non-myelinated C fibers a composition comprising an ethanol extract of Brazilian green propolis (′BGP″),
wherein the ethanol extract of BGP is produced by extracting BGP with an aqueous solution of 60 to 80% ethanol,
wherein the extraction is carried out at a pH between about 6 and about 8,
wherein the composition comprises 1.0 to 5 wt % Artepillin C, 1-5 wt % drupanin, 5 wt % baccharin, and less than 0.01 wt ° % a fortriononetin;
wherein the dose is administered by a method selected from the group consisting of topical, oral, parenteral, respiratory, and combinations thereof;
wherein the dose ranges from 0.01 to 100 mg/kg/day; and
wherein the early phase neurogenic analgesic response is stronger at a dose of 50 mg/kg than the response at 100 mg/kg.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pain from the burn is non-inflammatory pain.

### Claim 3 (depends on 1)

The method of claim 1, wherein the nociceptive pain is an early phase response mediated by myelinated A-sigma, A-beta, or A-alpha fibers.

### Claim 4 (depends on 1)

The method of claim 1, wherein the nociceptive pain further comprises late phase response resulting from an inflammatory response in combination with activation of N-methyl-d-aspartate (NMDA) and non-NMDA receptors and NO cascade.

### Claim 5 (depends on 1)

The method of claim 1, wherein the ethanol extract of BGP is produced by extracting BGP with an aqueous solution of at least 70% ethanol.

### Claim 6 (depends on 1)

The method of claim 1, wherein the composition further comprises an oil extract of BOP.

### Claim 7 (depends on 1)

The method of claim 1, wherein the composition further comprises a vegetable oil extract of BGP.

### Claim 8 (depends on 1)

The method of claim 1, wherein the composition further comprises a vegetable oil extract of BGP that has been emulsified with the ethanol extract of BGP.

### Claim 9 (depends on 1)

The method of claim 1, where the composition further comprises a NSAID or an opioid.

### Claim 10 (depends on 1)

The method of claim 1, wherein the composition further comprises a sunblock or sunscreen and is topically administered to the subject.

### Claim 11 (depends on 1)

The method of claim 1, wherein the composition is topically administered to the subject.

### Claim 12 (depends on 1)

The method of claim 1, wherein the composition is administered to the subject prior to a burn.

### Claim 13 (depends on 1)

The method of claim 1, further comprising exposing at least a portion of the burn of the subject in need of treatment to UV light at an intensity of 5-50 mW/cm2 for up to ½ hour ½ hour or less prior to administering the composition comprising the BGP ethanol extract to the burn, wherein the UV light is in a wavelength range of 780-400 nm.

### Claim 14 (depends on 1)

The method of claim 1, wherein the composition is administered intravenously, intramuscularly, or orally.

### Claim 15 (depends on 1)

The method of claim 1, wherein the composition further comprises a mixture of one or more water-ethanol, ethanol-oil, or water-oil extracts of BGP.