# US 2021/0330703 A1 · Selenium disulfide compositions for use in treating meibomian gland dysfunction

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- Number: US 2021/0330703 A1
- Document ID: US20210330703A1
- Status: Published application
- Kind: A1
- Application number: 17/320,731
- Filed: 2021-05-14
- Published: 2021-10-28
- Earliest claimed: 2016-04-14
- Assignees: Azura Ophthalmics Ltd.
- Applicants: Azura Ophthalmics Ltd.
- Inventors: Doron FRIEDMAN; Yair ALSTER; Omer RAFAELI; Shimon AMSELEM; Zakhar NUDELMAN
- Web page: https://patentgrep.com/patent/US20210330703A1

## CPC

- A61K 33/04: Sulfur, selenium or tellurium; Compounds thereof
- 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 9/0048: {Eye, e.g. artificial tears}
- A61K 9/06: Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)}
- A61K 9/16: Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)}
- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- 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 27/02: Ophthalmic agents
- A61P 27/04: Artificial tears; Irrigation solutions
- 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

Described herein are compositions and methods for the treatment of meibomian gland dysfunction. Said methods are performed by administering said composition comprising a selenium disulfide and an anhydrous semi-solid base. The stable anhydrous composition are substantially free of selenium disulfide agglomerates.

## Claims

### Claim at position 1

1-29. (canceled)

### Claim 30

A composition comprising selenium disulfide and an anhydrous semi-solid ophthalmic base, wherein any selenium disulfide particles of the composition have an average diameter of less than 50 μm, wherein the composition comprises less than 10 wt. % of surfactants and dispersing agents, and wherein the composition is suitable for topical administration on an eyelid margin.

### Claim 31 (depends on 30)

The composition of claim 30, wherein the selenium disulfide is dispersed in the anhydrous semi-solid ophthalmic base.

### Claim 32 (depends on 30)

The composition of claim 30, wherein the anhydrous semi-solid ophthalmic base is an oleaginous base selected from the group consisting of petroleum, white petroleum, mineral oil, vegetable oils and combinations thereof.

### Claim 33 (depends on 32)

The composition of claim 32, wherein the anhydrous semi-solid ophthalmic base is petroleum or mineral oil.

### Claim 34 (depends on 30)

The composition of claim 30, wherein the composition is formulated as a spreadable lip balm-or stick-like product.

### Claim 35 (depends on 30)

The composition of claim 30, wherein the composition or base thereof has a melting point between about 34° C. and about 50° C.

### Claim 36 (depends on 30)

The composition of claim 30, wherein the composition further comprises squalene or hydrogenated oil.

### Claim 37 (depends on 36)

The composition of claim 36, wherein the composition comprises 5 wt % to 30 wt % squalene.

### Claim 38 (depends on 36)

The composition of claim 36, wherein the composition comprises 8 wt % to 30 wt % hydrogenated oil.

### Claim 39 (depends on 30)

The composition of claim 30, wherein any disulfide agglomerates in the composition have a particle diameter of less than 20 μm.

### Claim 40 (depends on 30)

The composition of claim 30, wherein any selenium disulfide particles of the composition have an average selenium disulfide particle diameter of less than about 20 μm.

### Claim 41 (depends on 30)

The composition of claim 30, wherein any selenium disulfide particles of the composition have an average selenium disulfide particle diameter of about 5 μm to about 20 μm.

### Claim 42 (depends on 30)

The composition of claim 30, wherein any selenium disulfide particles of the composition have an average selenium disulfide particle diameter of less than about 15 μm.

### Claim 43 (depends on 30)

The composition of claim 30, wherein any selenium disulfide particles of the composition have an average selenium disulfide particle diameter of about 5 μm to about 10 μm.

### Claim 44 (depends on 30)

The composition of claim 30, wherein the composition does not contain selenium disulfide particles larger than 20 μm in diameter.

### Claim 45 (depends on 30)

The composition of claim 30, wherein the composition is substantially free of surfactants and dispersing agents.

### Claim 46 (depends on 30)

The composition of claim 30, wherein the composition comprises less than 1 wt. % of surfactants and dispersing agents.

### Claim 47 (depends on 30)

The composition of claim 30, further comprising degradants of selenium disulfide.

### Claim 48 (depends on 47)

The composition of claim 47, wherein an amount of the degradants does not increase during a storage period, under accelerated stability conditions, at a temperature of 40° C.

### Claim 49 (depends on 30)

The composition of claim 30, wherein the composition further comprises a small amount of degradants of selenium disulfide, wherein the amount of the degradants does not increase above 1% of the total weight of the composition.
