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Compositions containing alkali metal sulfate salts of conjugated estrogens and antioxidants as stabilizers

  • US 4,154,820 A
  • Filed: 09/26/1977
  • Issued: 05/15/1979
  • Est. Priority Date: 02/23/1976
  • Status: Expired due to Term
First Claim
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1. A stabilized therapeutic preparation exhibiting no oxidation and less than about 5% hydrolysis up to at least 24 months, said preparation adapted for treatment of menopausal syndrome, female hypogonadism, amenorrhea, female castration, primary ovarian failure, abnormal uterine bleeding due to hormonal imbalance, and senile vaginitis, consisting essentially of:

  • at least one alkali metal sulfate salt of a synthetic conjugated estrogen selected from the group consisting of estrone, equilin, 17α

    -dihydroequilin, 17β

    -hydroequilin, 17β

    -estradiol, 17α

    -estradiol, equilenin, and 17β

    -dihydroequilenin in estrogenically effective proportions, andan antioxidant effective amount of at least one suitable antioxidant for said alkali metal sulfate salt of said synthetic conjugated estrogen selected from the group consisting of sodium sulfite, potassium sulfite, sodium metabisulfite, potassium metabisulfite, sodium bisulfite, potassium bisulfite, sodium thiosulfate, potassium thiosulfate, thioglycerol, thiosorbitol, cysteine hydrochloride, and α

    -tocopherol, wherein the preparation is maintained at an alkalinity corresponding to a pH of not less than about 7.0.

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