Topical formulations comprising a steroid
AssigneeDr. Reddy's Laboratories, Inc.
InventorsUdhumansha UBAIDULLA, Sateesh KANDAVILLI, Ajay Sunil VAIRALE, Jeffrey A. WAYNE, Vijendra NALAMOTHU, Mistry MEGHAL, Refika Isil PAKUNLU
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Abstract
The application provides formulations for the topical administration of an active agent comprising at least one steroid, in the form of topical sprays that are propellant-free, and/or substantially non-foaming, and/or alcohol-free. The present application also provides processes for preparing such compositions and methods of using them in management of skin diseases or disorders such as psoriasis, dermatoses, and other associated skin diseases or disorders.
Claims30
A topical pharmaceutical composition comprising:
- a betamethasone compound;
- an emulsifying agent;
- water;
- a water-immiscible substance;
- and
- a skin penetration enhancer;
- wherein the composition is aqueous based emulsion having average particle sizes of the dispersed phase droplets are less than about 500 μm.
The composition according to claim 4, wherein the emulsifying agent is selected from the group comprising of a sorbitan fatty acid ester, a mixture of partial esters of sorbitol and its mono- and di-anhydrides with fatty acids, a polyethylene glycol stearate, a glycol stearate, sodium lauryl sulphate, cetyl trialkyl ammonium bromide, a polyoxyethylene sorbitan fatty acid ester, or any combination thereof.
The composition according to claim 6, wherein the skin penetration enhancer is selected from the group comprising of:
- butanediol, polyethylene glycol monolaurate, diethylene glycol monoethyl ether, dimethylsulfoxide, decylmethylsulfoxide, lauric acid, oleic acid, valeric acid, isopropyl myristate, isopropyl palmitate, methyl propionate, ethyl oleate, or any combination thereof.
A topical pharmaceutical composition comprising:
- a betamethasone compound;
- an emulsifying agent;
- water;
- a water-immiscible substance;
- and
- a skin penetration enhancer selected from the group consisting of butanediol, polyethylene glycol monolaurate, diethylene glycol monoethyl ether, dimethylsulfoxide, decylmethylsulfoxide, lauric acid, oleic acid, valeric acid, isopropyl myristate, isopropyl palmitate, methyl propionate, ethyl oleate, and combinations thereof;
- wherein the composition is non-foaming, propylene glycol-free, alcohol-free, and propellant-free.
A composition comprising:
- a betamethasone compound;
- an emulsifying agent;
- water;
- a water-immiscible substance;
- and
- a skin penetration enhancer;
- wherein the composition is an aqueous-based composition having viscosity in the range of from about 10 to about 15,000 centipoise.
Dependencies are inferred from the claim text.