# US 10,441,630 B2 · Topical formulations and uses thereof

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- Number: US 10,441,630 B2
- Document ID: US10441630B2
- Status: Granted
- Kind: B2
- Application number: 15/153,640
- Filed: 2016-05-12
- Published: 2016-09-08
- Granted: 2019-10-15
- Earliest claimed: 2012-08-24
- Assignees: Sun Pharma Global Fze
- Applicants: Ocular Technologies Sarl
- Inventors: Ashim K. Mitra; Sidney L. Weiss; Eugene J. McNally
- Web page: https://patentgrep.com/patent/US10441630B2

## CPC

- A61K 38/13: Cyclosporins
- A61K 9/0048: {Eye, e.g. artificial tears}
- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- 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 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- 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

Provided herein include formulations for topical administration, such as ophthalmic formulations, and methods of using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and or a polyalkoxylated alcohol and may include nanomicelles. Also include methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.

## Claims

### Claim 1

An aqueous clear nanomicellar ophthalmic formulation, comprising:
an active agent,
0.5-4.5% by weight of a polymer comprising HCO-40, HCO-60, HCO-80, HCO-100, polyoxyl 35 castor oil or combinations thereof; and
0.02-0.08% of a polyalkoxylated alcohol.

### Claim 2 (depends on 1)

The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer comprises HCO-40, HCO-60, HCO-80, HCO-100 or combinations thereof.

### Claim 3 (depends on 1)

The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polyalkoxylated alcohol is Octoxynol-40.

### Claim 4 (depends on 2)

The aqueous clear nanomicellar ophthalmic formulation of claim 2, wherein said polymer is HCO-40.

### Claim 5 (depends on 2)

The aqueous clear nanomicellar ophthalmic formulation of claim 2, wherein said polymer is HCO-60.

### Claim 6 (depends on 1)

The aqueous clear nanomicellar ophthalmic formulation of claim 1, wherein said polymer is 1-4% by weight.

### Claim 7 (depends on 3)

The aqueous clear nanomicellar ophthalmic formulation of claim 3, wherein Octoxynol-40 is 0.05% by weight.