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#Grand Rounds

Compounding Pharmacies: How Consistent is Composition of Combined Estradiol and Progesterone Capsules and Creams?

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BACKGROUND AND PURPOSE:

  • There is a high demand for hormone therapy consisting of natural hormones
  • There is an FDA formulation available
    • However, many prescriptions are still filled by compounding pharmacies
  • Stanczyk et al. (Menopause, 2019) examined the doses of estradiol and progesterone found in compounded combined oral capsules and transdermal creams, to determine the consistency of compounded hormone formulations

METHODS:

  • Combined estradiol (0.5mg) and progesterone (100mg) capsules and creams were requested from 15 custom-compounding pharmacies
  • Estradiol and progesterone levels were measured by radioimmunoassays
  • Hormone levels were measured in
    • 2 capsules and 2 creams from each pharmacy
    • 10 capsules from 3 pharmacies
    • Top/middle/bottom layer of cream containers to assess consistency

RESULTS:

  • 13 pharmacies filled prescriptions for the capsules and creams
  • Estradiol levels
    • Capsules: 0.365 to 0.551
    • Creams: .433 to 0.55 mg/g
  • Progesterone levels
    • Capsules: 90.8 to 135 mg
    • Creams: 93 to 118 mg/g
  • For both estradiol and progesterone levels
    • There were greater variations between pharmacies for capsules than creams
    • Hormone levels within pharmacies were more consistent in the capsules than the creams

CONCLUSION:

  • There is considerable variation in estradiol and progesterone levels in compounded hormone therapy formulations
  • NAMS, ACOG and FDA have voiced concerns regarding unregulated hormonal products

Learn More – Primary Sources:

Determination of estradiol and progesterone content in capsules and creams from compounding pharmacies

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