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. STUDY DESIGN: 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. CONCLUSION: 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.
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. STUDY DESIGN: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. CONCLUSION: 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: Steve N Caritis; Shringi Sharma; Raman Venkataramanan; Gary D Hankins; Menachem Miodovnik; Mary F Hebert; Jason G Umans; Thomas Benedetti; Donald Mattison; Anne Zajicek; Dawn Fischer; Aimee Jackson Journal: Am J Obstet Gynecol Date: 2012-08-16 Impact factor: 8.661
Authors: Steve N Caritis; Hyagriv N Simhan; Yuan Zhao; Dwight J Rouse; Alan M Peaceman; Anthony Sciscione; Catherine Y Spong; Michael W Varner; Fergal D Malone; Jay D Iams; Brian M Mercer; John M Thorp; Yoram Sorokin; Marshall Carpenter; Julie Lo; Susan M Ramin; Margaret Harper Journal: Am J Obstet Gynecol Date: 2012-08-06 Impact factor: 8.661
Authors: Paul J Meis; Mark Klebanoff; Elizabeth Thom; Mitchell P Dombrowski; Baha Sibai; Atef H Moawad; Catherine Y Spong; John C Hauth; Menachem Miodovnik; Michael W Varner; Kenneth J Leveno; Steve N Caritis; Jay D Iams; Ronald J Wapner; Deborah Conway; Mary J O'Sullivan; Marshall Carpenter; Brian Mercer; Susan M Ramin; John M Thorp; Alan M Peaceman; Steven Gabbe Journal: N Engl J Med Date: 2003-06-12 Impact factor: 91.245