Topical steroid composition and method

  • US 8,962,028 B2
  • Filed: 06/19/2013
  • Issued: 02/24/2015
  • Est. Priority Date: 10/18/2012
  • Status: Active Grant
First Claim
Patent Images

1. A storage stable, topical lotion composition for treating a skin disorder or condition, said composition comprising:

  • a halobetasol material comprising halobetasol or its pharmaceutically acceptable salts, esters, and solvates; and

    a pharmaceutically acceptable carrier which includes;

    (a) one or more fatty alcohols and/or one or more alkoxylated fatty alcohols, (b) one or more polyol humectants, and (c) diisopropyl adipate, wherein the amount of said halobetasol material after storage for six months at 40°

    C. is >

    98.5% of the total amount of halobetasol material present at the time of manufacture of the topical lotion, wherein the amount of degradation of said halobetasol material after storage for 26 months at 30°

    C. is <

    1% of the total amount of halobetasol material present at the time of manufacture of the topical lotion and wherein the amount of degradation of said halobetasol material after storage at 25°

    C. for 30 months is <

    3% of the total amount of halobetasol material present at the time of manufacture of the topical lotion, andwherein the ratio of said fatty alcohols and alkoxylated fatty alcohols to said humectants, to said diisopropyl adipate is, on a weight basis, in the range of 30-60;

    30-60;

    5-15.

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