# US 11,433,025 B2 · Oil foamable carriers and formulations

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- Number: US 11,433,025 B2
- Document ID: US11433025B2
- Status: Granted
- Kind: B2
- Application number: 15/999,088
- Filed: 2018-08-17
- Published: 2019-03-28
- Granted: 2022-09-06
- Earliest claimed: 2007-12-07
- Assignees: Vyne Therapeutics Inc.
- Applicants: Vyne Pharmaceuticals Ltd.
- Inventors: Dov Tamarkin; Helena Shifrin; Rita Keynan; Enbal Ziv; Tal Berman; David Schuz; Elana Gazal
- Web page: https://patentgrep.com/patent/US11433025B2

## CPC

- A61K 9/12: Aerosols; Foams {(A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015)}
- A61K 8/046: {Aerosols; Foams}
- 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 9/122: {Foams; Dry foams (edible foams A61K9/0056)}
- A61K 31/20: having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K 31/355: Tocopherols, e.g. vitamin E
- A61K 31/522: having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
- A61K 31/59: Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K 31/65: Tetracyclines
- A61K 31/7056: containing five-membered rings with nitrogen as a ring hetero atom
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/24: containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 41/00: Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
- 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 waterless foamable pharmaceutical composition suitable for external administration is disclosed. The composition includes a foamable carrier least one liquefied or compressed gas propellant. The foamable carrier includes at least one liquid oil; at least one silicone and at least one least one stabilizing agent; wherein the stabilizing agent selected from the group consisting of about 0.01% to about 25% by weight of at least one surface-active agent alone or on combination with a foam adjuvant; and about 0% to about 5% by weight of at least one polymeric agent alone or on combination with a foam adjuvant; and mixtures thereof. Pharmaceutical compositions comprising active agents, methods for their preparation, propellants suitable for use with the carriers and uses thereof are further described.

## Claims

### Claim 1

An essentially waterless foam composition comprising:
(a) a liquid oil;
(b) a modulating agent;
(c) a foam stabilizing agent comprising at least two surface-active agents;
(d) an emollient comprising a solid wax and/or solid oil; and
(e) a silicone;
wherein the surface-active agents are not sorbitan fatty acid esters;
wherein the composition does not contain a polymeric agent; and
wherein the foam does not comprise a pharmaceutical or cosmetic active agent.

### Claim 2 (depends on 1)

The foam composition of claim 1, wherein the liquid oil is about 60% to about 95% by weight of the composition.

### Claim 3 (depends on 1)

The foam composition of claim 1, wherein the liquid oil is selected from the group consisting of a mineral oil, a MCT oil, a liquid paraffin, a vegetable oil, an essential oil, an organic oil, a lipid, or a mixture of two or more thereof.

### Claim 4 (depends on 1)

The foam composition of claim 1, wherein the liquid oil is a mixture of heavy mineral oil and light mineral oil having a weight ratio from about 1:5 to about 25:1.

### Claim 5 (depends on 1)

The foam composition of claim 1, wherein the amount of the at least two surface-active agents is between about 0.2% and about 8% by weight of the composition.

### Claim 6 (depends on 1)

The foam composition of claim 1, wherein the at least two surface-active agents comprise between about 1% and about 6% by weight of the composition.

### Claim 7 (depends on 1)

The foam composition of claim 1, wherein the modulating agent is between about 0.1% to about 10% by weight of the composition.

### Claim 8 (depends on 1)

The foam composition of claim 1, wherein the modulating agent is between about 1% to about 5% by weight of the composition.

### Claim 9 (depends on 1)

The foam composition of claim 1, wherein at least one of the surface-active agents comprises a fatty acid ester.

### Claim 10 (depends on 9)

The foam composition of claim 9, wherein the fatty acid ester is selected from the group consisting of a monoglyceride, diglyceride, or triglyceride, or a mixture of any two or more thereof, wherein the side chain of the monoglyceride, diglyceride, or triglyceride is a saturated hydrocarbon.

### Claim 11 (depends on 9)

The foam composition of claim 9, wherein the fatty acid ester comprises glyceryl monostearate.

### Claim 12 (depends on 1)

The foam composition of claim 1, wherein the solid wax or solid oil comprises a solid paraffin, a hydrogenated oil, a hydrogenated emollient, palmitic acid, or a mixture of any two or more thereof.

### Claim 13 (depends on 1)

The foam composition of claim 1, wherein the emollient comprises a solid wax and a solid oil.

### Claim 14 (depends on 13)

The foam composition of claim 13, wherein the emollient further comprises a cocoglyceride, PPG 15 stearyl alcohol, octyldodecanol, isopropyl myristate, diisopropyl adipate, cetearyl octanoate isohexadecanol, diisopropyl adipate, or a mixture of any two or more thereof.