# US 12,005,068 B2 · Formulation including doxycycline hyclate and method for administering the same

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- Number: US 12,005,068 B2
- Document ID: US12005068B2
- Status: Granted
- Kind: B2
- Application number: 17/022,294
- Filed: 2020-09-16
- Published: 2021-01-21
- Granted: 2024-06-11
- Earliest claimed: 2017-07-06
- Applicants: Bruce Roseman
- Inventors: Bruce Roseman
- Web page: https://patentgrep.com/patent/US12005068B2

## CPC

- A61K 31/65: Tetracyclines
- A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)}
- A61K 9/107: Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)}
- A61P 25/02: for peripheral neuropathies
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

A topical formulation for transdermal delivery of sub-acute does of doxycycline hyclate to treat pain and inflammation may include: a base suspension; and doxycycline hyclate. The doxycycline hyclate is mixed with the base suspension in a proportion such that the formulation lacks any antibiotic effect and the concentration of doxycycline hyclate is between 200 and 600 mg/g inclusive. A method of applying the formulation is also disclosed.

## Claims

### Claim 1

A method of administering a topical formulation for transdermal delivery of doxycycline hyclate for treating headache pain in a subject in need of such treatment, said method comprises:
(a) providing the formulation, the formulation comprising; doxycycline hyclate disposed in a suspension; wherein the doxycycline hyclate in a dose is transdermally deliverable at a portion of the skin evincing the pain, whereby the pain is diminished; and
(b) applying a layer of the formulation to the skin evincing the pain.

### Claim 2 (depends on 1)

The method of claim 1, wherein the doxycycline hyclate has a concentration in the suspension of between 200 and 600 mg/g.

### Claim 3 (depends on 1)

The method of claim 1, wherein the doxycycline hyclate has a concentration in the suspension of 400 mg/g.

### Claim 4 (depends on 1)

The method claim 1, wherein the suspension is an oil-in-water suspension.

### Claim 5 (depends on 1)

The method of claim 1, wherein the suspension has non-comedogenic and hypoallergenic properties.

### Claim 6 (depends on 1)

The method of claim 1, wherein the pain comprises severe headache pain.

### Claim 7

A method of treating headache pain in a subject in need of such treatment, said method comprises: providing a topical formulation comprising doxycycline hyclate in a suspension, and applying the formulation to the skin evincing the headache pain.

### Claim 8 (depends on 7)

The method of claim 7, wherein the doxycycline hyclate has a concentration in the suspension of between 200 and 600 mg/g.

### Claim 9 (depends on 7)

The method of claim 7, wherein the doxycycline hyclate has a concentration in the suspension of 400 mg/g.

### Claim 10 (depends on 7)

The method of claim 7, wherein the suspension is an oil-in-water suspension.

### Claim 11 (depends on 7)

The method of claim 7, wherein the suspension has non-comedogenic and hypoallergenic properties.

### Claim 12

A topical headache pain composition comprising doxycycline hyclate disposed in a suspension, wherein the doxycycline hyclate has a concentration of 400 mg/g.

### Claim 13

A topical headache pain composition comprising doxycycline hyclate disposed in a suspension, wherein the suspension is an oil-in-water suspension.

### Claim 14 (depends on 1)

The method of claim 1, wherein the pain comprises a neuropathy.

### Claim 15 (depends on 7)

The method of claim 7, wherein the pain comprises a neuropathy.

### Claim 16 (depends on 1)

The method of claim 1, wherein (b) further comprises applying the formulation adjacent a muscle evincing the pain.

### Claim 17 (depends on 7)

The method of claim 7, wherein said applying further comprises applying the formulation adjacent a muscle evincing the pain.