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Ethical Observations on the Choice of Parenteral Solvents
Authors:Elise Bracq  Malika Lahiani-Skiba  Michel Guerbet
Affiliation:1. Biologie SERVIER, Toxicology Center, Gidy, Franceelise.bracq@orange.fr;3. Laboratory of Pharmaceutical Technology and Biopharmacy, ADEN EA 3234, Rouen University Faculty of Medicine and Pharmacy, Rouen cedex, France;4. Laboratory of Toxicology, ADEN EA 3234, Rouen University Faculty of Medicine and Pharmacy, Rouen cedex, France
Abstract:The parenteral administration of insoluble drugs leads to the use of biologically active solvents inducing effects associated with ethical cause of concern including pain and pharmacological interactions. Selected vehicles currently used were ethically and scientifically reviewed. Our investigations allowed reinforcing the formulation decision tree with an ethical point of view. The last generation of cyclodextrin appears to be the safest solvent. Second choice could be lipidic emulsions, third choice being co-solvents, and finally non-ionic surfactants because of their hypersensitivity reactions. Screening tests including pH, osmolality measurements, cytotoxicity, and hemotoxicity, should allow to check the formulation tolerance before the animals' administration.
Keywords:solvents  toxicology  parenteral administration  adverse effects  ethical considerations
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