Compounding Pharmacies: How Consistent is Composition of Combined Estradiol and Progesterone Capsules and Creams?
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
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
13 pharmacies filled prescriptions for the capsules and creams
Capsules: 0.365 to 0.551
Creams: .433 to 0.55 mg/g
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
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
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