An. R. Acad. Nac. Farm., Vol 75, No 4 (2009)

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Formulation of cyclosporine 2% eyedrops solutions for clinical practice

Elena Pérez Hernando, Luis Alberto del Río

Abstract


The cyclosporine eyedrops in the current pharmaceutical practice display deficiencies that cause their quality and safety not acceptable, especially when a commercialized made up drug is used like source of raw material. In the present investigation, the source of active principle is defined, the ingredients, the methods of making-up of the formulations and their evaluation that includes solving, manufacturing and physical stability as well as the tolerance of the vehicles in healthy volunteers. Aqueous and oily formulations cyclosporine 2% eyedrops have been manufactured using vehicles like isopropyl myristate, oleoyl macrogolglycerides, medium chain triglycerides, olive oil and saline solution. Cyclosporine and isopropyl myristate formula is the most suitable and it is proposed to be included into the Spanish National Formulary.





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