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Prevention of preterm delivery with compounded 17a-hydroxyprogesterone caproate
Dana Reed-Kane1, Karen Kirschbaum
1Reed's Compounding Pharmacy, Tucson, Arizona.
International Journal of Pharmaceutical Compounding
|August 27, 2013
Summary
17a-hydroxyprogesterone caproate is crucial for preventing preterm birth. Due to lack of FDA approval, compounded versions are in demand, requiring strict USP standards for safety and efficacy.
Area of Science:
- Reproductive endocrinology and pharmacology
- Maternal-fetal medicine
Background:
- 17a-hydroxyprogesterone caproate, a progesterone metabolite, is vital during pregnancy.
- Increased interest in compounded formulations due to lack of FDA-approved versions and a large trial on preterm birth prevention.
Purpose of the Study:
- To review literature and studies on 17a-hydroxyprogesterone caproate.
- To highlight the importance of compounded formulations in meeting demand.
Main Methods:
- Literature review of past and present clinical studies.
- Analysis of factors driving demand for compounded 17a-hydroxyprogesterone caproate.
Main Results:
- Significant interest in compounded 17a-hydroxyprogesterone caproate for preterm delivery prevention.
- Compounded formulations are necessary due to the absence of an FDA-approved manufactured form.
Conclusions:
- Compounding pharmacies must adhere to USP Chapter 797 standards for safety, potency, and sterility.
- Ensuring quality in compounded 17a-hydroxyprogesterone caproate is critical for its use in pregnancy.
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