title: Stability of Alprostadil in 0.9% Sodium Chloride Stored in Polyvinyl Chloride Containers.
abstract: The stability of alprostadil diluted in 0.9% sodium chloride stored in polyvinyl chloride (VIAFLEX) containers at refrigerated temperature, protected from light, is reported. Five solutions of alprostadil 11 mcg/mL were prepared in 250 mL 0.9% sodium chloride polyvinyl chloride (PL146) containers. The final concentration of alcohol was 2%. Samples were stored under refrigeration (2°C to 8°C) with protection from light. Two containers were submitted for potency testing and analyzed in duplicate with the stability-indicating high-performance liquid chromatography assay at specific time points over 14 days. Three containers were submitted for pH and visual testing at specific time points over 14 days. Stability was defined as retention of 90% to 110% of initial alprostadil concentration, with maintenance of the original clear, colorless, and visually particulate-free solution. Study results reported retention of 90% to 110% initial alprostadil concentration at all time points through day 10. One sample exceeded 110% potency at day 14. pH values did not change appreciably over the 14 days. There were no color changes or particle formation detected in the solutions over the study period. This study concluded that during refrigerated, light-protected storage in polyvinyl chloride (VIAFLEX) containers, a commercial alcohol-containing alprostadil formulation diluted to 11 mcg/mL with 0.9% sodium chloride 250 mL was stable for 10 days.
authors.affiliation: Mayo Clinic Rochester, Rochester, Minnesota. mccluskey.susan@mayo.edu.
authors.forename: Susan V
authors.initials: SV
authors.lastname: McCluskey
authors.affiliation: Mayo Clinic Rochester, Rochester, Minnesota.
authors.forename: Kylian
authors.initials: K
authors.lastname: Kirkham
authors.affiliation: ARL Bio Pharma, Inc., Oklahoma City, Oklahoma.
authors.forename: Jessica M
authors.initials: JM
authors.lastname: Munson
mesh_terms: D000527:Alprostadil / Q000737:chemistry* / Q000494:pharmacology / Q000528:radiation effects; D002851:Chromatography, High Pressure Liquid; D003080:Cold Temperature; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005079:Excipients / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D007552:Isotonic Solutions; D008027:Light; D010975:Platelet Aggregation Inhibitors / Q000737:chemistry* / Q000494:pharmacology / Q000528:radiation effects; D011143:Polyvinyl Chloride / Q000737:chemistry*; D012965:Sodium Chloride / Q000737:chemistry* / Q000528:radiation effects; D013997:Time Factors; D014665:Vasodilator Agents / Q000737:chemistry* / Q000494:pharmacology / Q000528:radiation effects
chemical_list: D005079:Excipients; D007552:Isotonic Solutions; D010975:Platelet Aggregation Inhibitors; D014665:Vasodilator Agents; D012965:Sodium Chloride; D011143:Polyvinyl Chloride; D000527:Alprostadil