Topical Pharmaceutical Foam Composition
First Claim
1. A topical aerosol foam formulation comprising:
- (a) one or more keratolytic agents dissolved or dispersed in an oil-in-water emulsion; and
(b) a propellant consisting essentially of one or more hydrofluoroalkanes contacting the emulsion to produce an immediate foaming action on expulsion from a pressurized container.
6 Assignments
0 Petitions
Accused Products
Abstract
A stable topical alcohol-free aerosol foam containing one or more keratolytic agents is provided. The foam-forming formulation is an emulsion which contains an HFA propellant and one or more keratolytic agents. The emulsion has an oil phase and an aqueous, i.e. water-containing, phase. The active agent(s) may be present in either phase of the emulsion or dispersed in the emulsion. The oil phase may consist at least in part of the HFA propellant. Either or both of the oil phase and the aqueous phase may contain one or more surfactants, emulsifiers, emulsion stabilizers, buffers, and/or other excipients. The foam is stable on the skin, for example, for at least 5 minutes at body temperature, preferably at least 20 minutes at body temperature, and disappears into the skin upon rubbing or after prolonged standing. In one embodiment, the formulation contains an HFA propellant which does not contain additional co-solvents or co-propellants. The formulations demonstrate reduced intensity of the odor and/or color associated with the keratolytic agent(s) as compared to conventional formulations containing keratolytic agents.
171 Citations
49 Claims
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1. A topical aerosol foam formulation comprising:
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(a) one or more keratolytic agents dissolved or dispersed in an oil-in-water emulsion; and
(b) a propellant consisting essentially of one or more hydrofluoroalkanes contacting the emulsion to produce an immediate foaming action on expulsion from a pressurized container. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47)
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16. The formulation of 15, wherein the papain is present in an amount from about 0.5% to about 40%.
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17. The formulation of 16, wherein the papain is present in an amount from about 1% to about 20%.
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18. The formulation of 16, wherein the papain is present in an amount from about 1% to about 10%.
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48. A method of making a topical foam aerosol formulation, the method comprising:
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(a) making an oil in water emulsion with a predominantly, more than 50%, aqueous phase, (b) dissolving or dispersing one or more keratolytic agents in the aqueous phase or oil phase prior to emulsification, and (c) adding a propellant consisting essentially of a hydrofluoroalkane or a mixture of hydrofluoroalkanes, without additional co-solvents or co-propellants, to the emulsion, wherein the emulsion produces an immediate foaming action on expulsion from a pressurized container. - View Dependent Claims (49)
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Specification