Three Generations of Cyclosporine A Formulations: An In Vitro Comparison

Generic and therapeutic substitution: a viewpoint on achieving best practice in Europe

“…The premise on which generic substitution rests is that the substituted drug is equivalent to the original drug. However, there are documented examples where pharmacological variations exist, even between originator and generic formulations and between different generic formulations of the ‘same’ drug [1, 2]. Although two formulations may be considered bioequivalent at a population level, individuals may fall outside of this range with some receiving higher or lower doses than expected [3, 4], irrespective of the manufacturer – branded or generic.…”

Amorphous cyclosporin nanodispersions for enhanced pulmonary deposition and dissolution

“…CsA, a cyclic undecapeptide, is of interest for immunosuppression in patient populations that have undergone organ transplantation procedures,3, 38 treatment of autoimmune diseases,38 and the management of chronic and inflammatory conditions, such as asthma 39. CsA is highly lyophilic and very poorly water soluble with an octanol/water partition coefficient (i.e., log P ) of 4.3,40 and a solubility of 7.3 µg/mL in water 41, 42.…”