Introduction: The chemical stability of prostaglandin E1 (PGE1) in physiological solution has been studied in different environmental conditions. However, very little data exist regarding the PGE1 stability and the consequent breakdown products in PGE1-based vasoactive cocktails under different environmental conditions. Objective: To evaluate the loss of the therapeutic efficacy of PGE1 either alone or in combination with other vasoactive substances under different storage conditions. Materials and Methods: Utilizing high performance liquid chromatography the PGE1 content was evaluated alone and in association with papaverine and papaverine plus phentolamine at temperatures of 2–8 and at 20°C, and after 15, 30, 60, 90 and 120 days of storage using multivariate statistical analysis of variance. Results: We found that the time of storage significantly affects PGE1 activity. Furthermore, both the storage temperature and cocktail composition had a significant effect on PGE1 stability. The chromatographic studies did not disclose the presence of the principal degradation products of PGE1 (PGA1, PGB1). The presence of papaverine and temperature of 20°C have the greatest effect on the degradation of PGE1 during the first 30 days of storage. Discussion: Temperature and time are prevalent factors determining the slow and progressive deterioration curve of PGE1 after 30 days of storage. None of the environmental conditions evaluated was so drastic to determine the presence of PGA1 and PGB1. Conclusion: For clinical use, one should note that PGE1 maintains 50–80% of its efficacy for about 1 month even if stored at room temperature (20°C) and/or combined with papaverine.

Keywords:
Prostaglandin E1, Papaverine, Phentolamine, Erectile dysfunction, Storage conditions
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© 2002 S. Karger AG, Basel
2002
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