Spray foam corticosteroid product

摘要

A foamable pharmaceutical composition and a method of treating corticosteroid-responsive dermatoses of the skin are disclosed. The foamable pharmaceutical composition comprises a corticosteroid compound as an active ingredient; a quick-break foaming agent including an aliphatic alcohol, water, a fatty alcohol and a surface active agent; a buffering agent; and a propellant. The foamable composition is disposed within a pressurizable container that comprises an aerosol valve assembly including a dip tube communicating with a valve orifice through which the foamable composition is dispensed and an actuator to start and stop dispensation. The valve assembly dispenses a conically-shaped spray at a rate of about 2 to about 0.3 g/sec and provides a foam having a density of about 0.12 to about 0.25 when sprayed at a distance of about 5 to about 10 cm from the valve orifice onto a glass surface that is at ambient room temperature.

主权项

1. A foamable pharmaceutical composition comprising: an effective amount of clobetasol propionate as an active ingredient; a quick-break foaming agent that comprises a straight or branched chain C1-C4 aliphatic alcohol, water, a fatty alcohol and a surface active agent; a buffering agent present in an amount sufficient to provide a pH value of about 3.0 to about 6.0; and a propellant; said foamable pharmaceutical composition being disposed in a pressurizable container at an internal pressure of about 40 to about 80 psi, said container comprising an aerosol valve assembly that includes a dip tube in communication with a valve orifice through which said foamable pharmaceutical composition can be dispensed and an actuator having a diameter of approximately 0.013 inches at the point of actuation to start and stop dispensation, said valve assembly on being actuated dispensing a substantially conically-shaped spray having an apex adjacent the valve orifice, said spray being dispensed at a rate of about 0.3 to about 2 g/sec, and wherein said foamable pharmaceutical composition provides an average foam bubble diameter of about 5 to about 40 μm, with at least 80 percent of the bubbles having a diameter of less than 40 μm, such that it forms a quick-breaking foam when applied to a skin surface.