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|Title:||Stabilized estradiol cream composition|
|Abstract:||Loss of potency of estradiol cream compositions found to be due to unexpected oxidation of estradiol. Improved cream composition comprises 1% or less 17.beta.-estradiol in the presence of stabilizing members selected from phenolic-type antioxidants, metal chelating agents, and suspending agents.|
|Inventor(s):||Bequette; Robert J. (Evansville, IN), Hobbs; Linda G. (Evansville, IN), Scott; Joseph A. (Evansville, IN)|
|Assignee:||Mead Johnson & Company (Evansville, IN)|
1. A cream composition for topical estrogen therapy which comprises 17.beta.-estradiol of a concentration of about 1% or less on a weight basis relative to the whole
composition and the remainder being a pharmaceutically acceptable carrier wherein said carrier contains as stabilizers from about 0.01 to about 10% by weight of at least one member selected from
(a) one or more phenolic-type antioxidants selected from the group consisting of t-butylhydroquinone, di-t-amylhydroquinone, di-t-butylhydroquinone, butylhydroxytoluene, butylhydroxyanisole, pyrocatechol, pyrogallol, propyl gallate, and nordihydroguaiaretic acid;
(b) one or more metal chelating agents selected from the group consisting of the sodium edetates (EDTA), and edatic acid; and
(c) one or more suspending agents selected from the group consisting of carbomer, carboxymethylcellulose, hydroxypropyl methylcellulose and methylcellulose.
2. The composition of claim 1 wherein the concentration of antioxidant is less than 0.1% by weight; the metal chelating agent is a sodium edetate which is present in a concentration of less than 0.1% by weight; at least one of the suspending agents is present in a concentration of 1% or less; and 17.beta.-estradiol is present at a 0.1% or less concentration on a weight basis relative to the whole composition.
3. The composition of claim 1 wherein the antioxidant is tertiary butylhydroquinone at a concentration of 0.2 parts per 1,000 parts cream; the metal chelating agent is disodium edetate at a concentration of 0.5 part per 1,000 parts cream; the suspending agent is hydroxypropyl methylcellulose at a concentration of 3 parts per 1,000 parts cream and 17.beta.-estradiol is at the concentration of 0.1 part per 1,000 parts cream.
4. The composition as recited in claim 3 which further comprises per 1,000 parts cream: stearyl alcohol, 70 parts; glyceryl monostearate, 40 parts; white ceresin wax, 70 parts; sodium lauryl sulfate, 3 parts; methylparaben, 1.5 parts; propylene glycol, 100 parts; and purified water, 712 parts.
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