Stability evaluation of a prostaglandin E1 saline solution packed in insulin syringes

Uebel, R.; Wium, Cherylynn Angela; Schmidt, Abraham C

doi:10.1038/sj.ijir.3900625

Cited by 8 publications

(3 citation statements)

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“…A number of PGE 1 stability studies have been reported (4, 20, 25 and 40 µg/mL PGE 1 in 0.9% sodium chloride stable for 15 days at 20°C,29 9.8 days at 25°C,22 10 days at 20°C30 and 6 weeks at 21°C,31 respectively). None of these studies were performed at 30°C with 1.5 or 15 µg/mL PGE 1 in 10% dextrose injection solution.…”

Section: Discussionmentioning

confidence: 99%

Stability of prostaglandin E₁solutions stored in polypropylene syringes for continuous intravenous administration to newborns

et al. 2017

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ObjectiveWe aimed to monitor the physicochemical stability of prostaglandin E1 (PGE1) 1.5 and 15 µg/mL in 10% dextrose stored in polypropylene syringes.MethodsWe developed a liquid chromatography-high resolution mass spectrometry (LC-HRMS) method to detect and quantify levels of PGE1. Method selectivity was performed with a mixture of PGE1 and its degradation products. Forced degradation tests were performed to determine which degradation products were most likely to form. PGE1 injection solutions in 10% dextrose were stored in unprotected and shielded-from-light polypropylene syringes in a climatic chamber. Samples were taken immediately after preparation (T0) and after 24, 48, 72 and 168 hours for analysis. PGE1 solutions were considered stable if ≥90.0% of the initial concentration was retained.ResultsThe LC-HRMS method was validated in the range of 0.086-0.200µg/mL PGE1 with trueness values between 98.2% and 100.3%, and repeatability and intermediate precision values of <2.2%and <4.7%, respectively. The quantification and detection limits of the method were 0.086 and 0.026µg/mL, respectively. PGE1 and its degradation products were resolved chromatographically. PGE1 injection solutions were≥90.0%stable after 48hours in unprotected from light (UPL) syringes. The solutions remained clear without precipitation, colour or pH modification and subvisible particles within the permitted levels. Prostaglandin A1 was the sole degradation product observed.ConclusionsA LC-HRMS method to evaluate PGE1 stability in a 10% dextrose was developed and validated. PGE1 1.5 and 15µg/mL in 10% dextrose solution are stable for 48hours when stored at 30ºC in UPL polypropylene syringes.

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Section: Discussionmentioning

confidence: 99%

Stability of prostaglandin E₁solutions stored in polypropylene syringes for continuous intravenous administration to newborns

et al. 2017

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“…A beyond-use date of three months if stored at 5°C was maintained. This was done because of the limited stability of alprostadil in solution, 17,18 although increased stability of compounded IC cocktails have been reported after the preparations were subjected to a number of freeze-thaw cycles. 19 The patients were informed about the drug substitution.…”

Section: Methodsmentioning

confidence: 99%

The substitution of Phentolamine with an equal amount of Chlopromazine as an alpha-blocker in vasoactive cocktails used for intracavernous injection therapy for the treatment of erectile dysfunction

Uebel

Schmidt

2007

South African Family Practice

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“…Because insurance companies do not usually cover ICT, its cost effectiveness is important for the patients. The stability of PGE1 can be 24 months at 5°C [10], and it still maintains 50% to 80% of its potency for 30 days at 20°C [11], even when mixed with papaverine. I strongly discourage the use of a vial older than 6 months.…”

Section: The First Office Visitmentioning

confidence: 98%

Penile injection training

Duff

McCullough

2006

Curr sex health rep

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Stability evaluation of a prostaglandin E1 saline solution packed in insulin syringes

Cited by 8 publications

References 5 publications

Stability of prostaglandin E₁solutions stored in polypropylene syringes for continuous intravenous administration to newborns

Stability of prostaglandin E₁solutions stored in polypropylene syringes for continuous intravenous administration to newborns

The substitution of Phentolamine with an equal amount of Chlopromazine as an alpha-blocker in vasoactive cocktails used for intracavernous injection therapy for the treatment of erectile dysfunction

Penile injection training

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Stability evaluation of a prostaglandin E1 saline solution packed in insulin syringes

Cited by 8 publications

References 5 publications

Stability of prostaglandin E1solutions stored in polypropylene syringes for continuous intravenous administration to newborns

Stability of prostaglandin E1solutions stored in polypropylene syringes for continuous intravenous administration to newborns

The substitution of Phentolamine with an equal amount of Chlopromazine as an alpha-blocker in vasoactive cocktails used for intracavernous injection therapy for the treatment of erectile dysfunction

Penile injection training

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Stability of prostaglandin E₁solutions stored in polypropylene syringes for continuous intravenous administration to newborns

Stability of prostaglandin E₁solutions stored in polypropylene syringes for continuous intravenous administration to newborns