Microbial challenge test of a novel epoprostenol sodium formulation

Microbial challenge test of a novel epoprostenol sodium formulation

AIM The aim of the current study was to present a comprehensive display of antimicrobial activity of a novel epoprostenol sodium formulation with respect to seven different microorganisms, two levels of inoculation (102-103 colony forming units [CFU]/mL and 105-106 CFU/mL), two diluents (sterile water for injection [SWI] and sterile saline [sodium chloride 0.9%] for injection [SSI]), two concen...

Stability and preservation of a new formulation of epoprostenol sodium for treatment of pulmonary arterial hypertension

The release of endogenous prostacyclin (PGI2) is depressed in patients with pulmonary arterial hypertension (PAH). PGI2 replacement therapy by epoprostenol infusion is one of the best treatments available for PAH. Here, we provide an overview of the current clinical data for epoprostenol. Epoprostenol treatment improves symptoms, exercise capacity, and hemodynamics, and is the only treatment th...

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

PURPOSE 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, Al...

Evaluation of a New Formulation of Epoprostenol Sodium in Japanese Patients with Pulmonary Arterial Hypertension (EPITOME4)

INTRODUCTION Pulmonary arterial hypertension (PAH) is associated with poor prognosis despite significant recent advances in its treatment. An intravenous formulation of epoprostenol sodium containing glycine and mannitol (epoprostenol GM; GlaxoSmithKline, London, UK) is widely used to treat PAH. A new formulation of epoprostenol sodium containing arginine and sucrose excipients (epoprostenol AS...

Erratum to: Evaluation of a New Formulation of Epoprostenol Sodium in Japanese Patients with a Pulmonary Arterial Hypertension (EPITOME4)