Abstract | INTRODUCTION: METHODS: The chemical stability and antimicrobial activity of 4 microg/ml and 130 microg/ml treprostinil in SDF were assessed according to United States and European Pharmacopeia. RESULTS: At both concentrations, treprostinil in SDF remained stable after incubation at 40 degrees C and ambient relative humidity for up to 52 h. Solution pH also remained stable (range 10.4-10.6), and the solutions were essentially free of particulate at all time points examined. Antimicrobial activity was measured using an antimicrobial effectiveness test after inoculation with five species of bacteria, yeast and mould. The antimicrobial activity of both concentrations of treprostinil met United States Pharmacopeia requirements. Further, the antimicrobial activity of treprostinil in SDF against gram-negative bacteria (> 4 log(10) reductions) exceeded that previously described for treprostinil in sterile saline. CONCLUSION: These results suggest that dilution of treprostinil with the alkaline solution SDF may reduce the risk of infection from inadvertent patient contamination compared with dilution of treprostinil in sterile saline.
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Authors | D Zaccardelli, K Phares, R Jeffs, A Doran, M Wade |
Journal | International journal of clinical practice
(Int J Clin Pract)
Vol. 64
Issue 7
Pg. 885-91
(Jun 2010)
ISSN: 1742-1241 [Electronic] India |
PMID | 20584221
(Publication Type: Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Infective Agents
- Antihypertensive Agents
- Water
- Sodium Chloride
- Epoprostenol
- treprostinil
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Topics |
- Anti-Infective Agents
(administration & dosage, pharmacology)
- Antihypertensive Agents
(pharmacology)
- Bacteria
(drug effects)
- Bacterial Infections
(prevention & control)
- Catheterization, Central Venous
- Drug Stability
- Epoprostenol
(administration & dosage, analogs & derivatives, pharmacology)
- Equipment Contamination
(prevention & control)
- Fungi
(drug effects)
- Humans
- Infusions, Intravenous
- Mycoses
(prevention & control)
- Sodium Chloride
- Time Factors
- Water
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