Stability and microbiological properties of a new formulation of epoprostenol sodium when reconstituted and diluted.

Drug Design, Development and Therapy
Olivier LambertNagesh Palepu

Abstract

Epoprostenol, used for the treatment of pulmonary arterial hypertension (PAH), has a number of limitations related to its short half-life in aqueous solution. The aim of this study was to evaluate the stability and microbiological properties of a new formulation, namely epoprostenol sodium with arginine and mannitol excipients (epoprostenol AM; Veletri®; Actelion Pharmaceuticals Ltd, Allschwil, Switzerland). Stability and microbiological properties of epoprostenol AM were investigated at 5°C, 25°C, and 30°C over a range of concentrations (3000-30,000 ng/mL) when reconstituted and immediately diluted with sterile water for injection (SWI) or sterile saline (sodium chloride 0.9%) for injection (SSI). Stability (change in potency over time) for up to 72 hours at 25°C and 30°C was measured immediately following dilution and after storage at 5°C. Shelf-life was assessed by determining the maintenance of potency over time relative to initial potency. For microbiological testing, diluted samples of epoprostenol AM were inoculated with a range of bacteria, yeasts, and molds for up to 14 days at 5°C or 4 days at 25°C. Epoprostenol AM reconstituted and immediately diluted to the required concentration with SWI or SSI was stable for up to...Continue Reading

References

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Citations

Oct 11, 2012·Drug Design, Development and Therapy·Olivier Lambert, Dirk Bandilla
Oct 19, 2013·Pharmacology & Therapeutics·David MontaniMarc Humbert
Oct 15, 2014·American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions·Sarah L GreigGreg L Plosker
Aug 21, 2015·Expert Opinion on Pharmacotherapy·Swanny PerrinOlivier Sitbon
Sep 27, 2012·Progress in Cardiovascular Diseases·Corey E Ventetuolo, James R Klinger
Feb 17, 2017·International Journal of Rheumatic Diseases·Ramya AithalaDebashish Danda
Nov 8, 2014·Journal of Infusion Nursing : the Official Publication of the Infusion Nurses Society·Martha S Kingman, Sandra Lombardi
Jan 18, 2017·European Respiratory Review : an Official Journal of the European Respiratory Society·Olivier Sitbon, Anton Vonk Noordegraaf
Jan 23, 2016·Heart Failure Reviews·Tomas PulidoJennifer Escobar

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