# US 12,178,893 B2 · Lip balm containing caffeine, nicotine or testosterone

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- Number: US 12,178,893 B2
- Document ID: US12178893B2
- Status: Granted
- Kind: B2
- Application number: 18/781,300
- Filed: 2024-07-23
- Published: 2024-11-14
- Granted: 2024-12-31
- Earliest claimed: 2018-08-13
- Assignees: Shear Kershman Laboratories, Inc.
- Applicants: Shear Kershman Laboratories, Inc.
- Inventors: Alvin Kershman; Jeff Shear; Doreen Linze
- Web page: https://patentgrep.com/patent/US12178893B2

## CPC

- A61K 8/0216: {Solid or semisolid forms}
- A61K 8/375: {the alcohol moiety containing more than one hydroxy group}
- A61K 8/4926: {having six membered rings}
- A61K 8/4953: {containing pyrimidine ring derivatives, e.g. minoxidil}
- A61K 8/63: Steroids; Derivatives thereof
- A61K 8/922: {of vegetable origin}
- A61Q 19/001: {Preparations for care of the lips}
- A61K 2800/412: Microsized, i.e. having sizes between 0.1 and 100 microns
- A61K 2800/52: Stabilizers
- A61K 2800/596: Mixtures of surface active compounds
- A61K 2800/92: Oral administration
- 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)
- A61Q: SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS

## Abstract

A lip balm formulation for applying to a lip including at least one lipid, a surfactant, and a testosterone active, wherein the lip balm formulation includes about 25 to 60 wt. % of the surfactant based on the total weight of the formulation; wherein the surfactant includes a mixture of mono- and diglycerides and propylene glycol; wherein the surfactant has an HLB of 4; wherein the lip balm formulation includes about 30 wt. % to 60 wt. % of the at least one lipid based on the total weight of the formulation; wherein the at least one lipid includes hydrogenated palm oil; and wherein the surfactant minimizes the surface tension of the at least one lipid.

## Claims

### Claim 1

A lip balm formulation for applying to a lip consisting of:
at least one lipid, a surfactant, and a testosterone active,
wherein the lip balm formulation contains about 25 to 60 wt. % of the surfactant based on the total weight of the formulation;
wherein the surfactant consists of a mixture of mono- and diglycerides and propylene glycol;
wherein the surfactant has an HLB of 4;
wherein the lip balm formulation contains about 30 wt. % to 60 wt. % of the at least one lipid based on the total weight of the formulation;
wherein the at least one lipid comprises hydrogenated palm oil; and
wherein the surfactant minimizes the surface tension of the at least one lipid.

### Claim 2 (depends on 1)

The lip balm formulation of claim 1, wherein the w/w ratio of the surfactant to the at least one lipid is in the range of about 1/3 to 3/1.

### Claim 3

A lip balm formulation for applying to a lip consisting of:
at least one lipid, a surfactant, and a testosterone active;
wherein the at least one lipid is in the range of about 30 wt. % to 60 wt. % based on the total weight of the formulation;
wherein the at least one lipid comprises hydrogenated palm oil;
wherein the surfactant is in the range of about 25 wt. % to 60 wt. % based on the total weight of the formulation;
wherein the testosterone is in the range of about 0.1 wt. % to 30 wt. % based on the total weight of the formulation;
an excipient selected from the group consisting of a stabilizer, a melting point adjuster, an oil, a flavoring, a sun screen, a pharmaceutical and glycerin;
wherein the surfactant consists of a mixture of mono- and diglycerides and propylene glycol with an HLB of 4; and
wherein the surfactant minimizes the surface tension of the at least one lipid.

### Claim 4 (depends on 3)

The lip balm formulation of claim 3, wherein the stabilizer comprises glyceryl tristearate.

### Claim 5 (depends on 1)

The lip balm formulation of claim 1, wherein the lip balm formulation, when applied to the lip, delivers the testosterone active in less than about one minute.

### Claim 6 (depends on 1)

The lip balm formulation of claim 1, wherein the testosterone active is present in the range of about 0.1 wt. % to 30 wt. % based on the total weight of the formulation.

### Claim 7 (depends on 3)

The lip balm formulation of claim 3, wherein the w/w ratio of the surfactant to the at least one lipid is in the range of about 1/3 to 3/1.

### Claim 8 (depends on 1)

The lip balm formulation of claim 1, wherein the lip balm formulation, when applied to the lip, delivers the testosterone active in less than about ten minutes.

### Claim 9 (depends on 3)

The lip balm formulation of claim 3, wherein the lip balm formulation, when applied to the lip, delivers the testosterone active in less than about one minute.

### Claim 10 (depends on 3)

The lip balm formulation of claim 3, wherein the lip balm formulation, when applied to the lip, delivers the testosterone active in less than about ten minutes.