title: Qualitative and quantitative measures of various compounded formulations of 17-alpha hydroxyprogesterone caproate.
abstract: OBJECTIVE
  17-alpha hydroxyprogesterone caproate (17-OHPC) is available both as an Food and Drug Administration (FDA)-approved medication and as a product prepared for individual patients by compounding pharmacies. Compounding pharmacies may omit the preservative that is used in the FDA-approved formulation or use an alternate preservative and may dispense 17-OHPC in containers that differ from the FDA-approved product. The objective of this study was to assess the stability and the microbiologic and pyrogen status of 17-OHPC formulations under various compounding and dispensing conditions.
  
  
  METHODS
  17-OHPC was prepared by a local compounding pharmacy. The formulations that were prepared included 1 identical to the FDA-approved product with benzyl alcohol as a preservative, 1 with benzalkonium chloride as a preservative, and 1 without a preservative. These various formulations were dispensed into either single-dose 1-mL plastic syringes or glass vials or 10-mL glass vials. The concentration of 17-OHPC and microbial and pyrogen status were evaluated at various time intervals over the ensuing 19 weeks.
  
  
  RESULTS
  The concentration of 17-OHPC did not change over the duration of study, regardless of the dispensing medium that was used or the absence or presence of any preservatives. The preparations remained microbe- and pyrogen-free during the study period, regardless of the dispensing medium that was used or the absence of presence of any preservatives.
  
  
  CONCLUSIONS
  Products that contained 17-OHPC tested in this study were quite stable over the 19-week period of study in different dispensing containers and in the absence or presence of a different preservative. The compounded products remained sterile and pyrogen-free during the period of observation.
authors: Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
authors: Steve N
authors: SN
authors: Caritis
authors: Yang
authors: Y
authors: Zhao
authors: Joseph
authors: J
authors: Bettinger
authors: Raman
authors: R
authors: Venkataramanan
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D004339:Drug Compounding / Q000592:standards*; D004340:Drug Contamination; D004355:Drug Stability; D004731:Endotoxins / Q000032:analysis; D006801:Humans; D006908:Hydroxyprogesterones / Q000737:chemistry / Q000592:standards* / Q000627:therapeutic use; D047928:Premature Birth / Q000517:prevention & control; D011310:Preservatives, Pharmaceutical / Q000592:standards*; D011749:Pyrogens / Q000032:analysis; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004731:Endotoxins; D006908:Hydroxyprogesterones; D011310:Preservatives, Pharmaceutical; D011749:Pyrogens; D000077713:17 alpha-Hydroxyprogesterone Caproate