Abstract
The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from compounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit set for the FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable.
Highlights
Babies born prematurely have higher rates of mortality and morbidity, and may have developmental difficulties later in life[1]
hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) A total of 11 HPC API samples were analyzed, including one lot from the FDA-registered supplier in Europe, seven from original manufacturers of bulk product in China, and three from repackagers located in the United
The results that were obtained in this study demonstrate variability in the quality of HPC injection prepared by compounding pharmacies, as well as variability in the quality of the HPC API that is available to make the compounded preparations
Summary
Babies born prematurely have higher rates of mortality and morbidity, and may have developmental difficulties later in life[1]. Risk factors for a woman having a preterm birth prior to 37 weeks of gestation include multiple gestations, short cervical length, and African-American descent. The subset of women who have experienced a prior spontaneous preterm birth are at an especially high risk of having another preterm birth[2]. Various forms of progesterone have been studied to reduce the risk of premature birth, using several different dosage forms and routes of delivery[3]. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend the use of progesterone to reduce preterm birth to women with a singleton pregnancy and a history of spontaneous preterm birth[5]
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