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QUIESCENT FOAMABLE COMPOSITIONS, STEROIDS, KITS AND USES THEREOF

  • US 20080206161A1
  • Filed: 01/25/2008
  • Published: 08/28/2008
  • Est. Priority Date: 10/25/2002
  • Status: Abandoned Application
First Claim
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1. A storable foamable emulsion composition adapted for delivery of an active pharmaceutical ingredient (API) to a delivery site in a subject, the composition comprising:

  • a) at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, an organic polar solvent, an emollient and mixtures thereof, at a concentration of about 2% to about 50% by weight;

    b) at least one surface-active agent at a concentration of about 0.01% to about 5% by weight;

    c) at least one polymeric agent selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent, each in a concentration of about 0.01% to about 5% by weight;

    d) water;

    e) an effective amount of at least one API selected from the group consisting of a steroid, a steroid derivative, and combinations thereof;

    f) optionally, a further active agent; and

    g) a propellant at a concentration of about 3% to about 25% by weight of the total foamable composition,wherein, at ambient temperature, the storable foamable emulsion composition is shakable, is resistant to centrifugation at about 3000 rpm for about 10 min, is substantially devoid of crystals, is resistant to at least one freeze-thaw cycle and does not phase separate within at least about one month;

    wherein the at least one API remains chemically stable for at least about one month; and

    wherein the composition is stored in an aerosol container and upon release expands to form a breakable foam having an average bubble size range of about 30 to about 250 micron.

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