Thursday, September 23, 2010
Stability of Injectable drugs
The stability and the quality of a medicine is conditioned by the several factors, that can be physical (temperature, light, humidity and radiations), chemical (insolubilities, pH, incompatibilities, effect of the solvents, container and atmospheric air) or biological (organisms and microorganisms). The tests of stability are one of the essential steps in the production of a medicine, because it seek the warranty of the quality, effectiveness and safety of the medicine after its storage and placement in the market. They also allow the determination of the period of validity and conditions of storage of the different formulations. The study Excipient hidrolysis and ester formation increase pH in the parenteral solution over aging had as a point to evaluate the physiochemical stability of a injectable solution of Conivaptan cloridrat, through the investigation of the molecular cause of the increase of the pH along the time of storage and the evaluation of the impact of this increase in the stability of the referred solution. Studies of this nature are important in the measure in that accomplish an evaluation of the risk of the physiochemical alterations that can happen during the storage of the medicine, as well as they elucidate the mechanisms that drive those alterations, what can be a more value for the resolution of stability problems . It is concluded the idea that the excipientes are inert substances is wrong and that the possibility of reaction occurrence that put in cause the stability, safety, quality and effectiveness of the medicine should be investigated.