STABILITY OF CO-AMOXICLAV RECONSTITUTED INJECTABLE SOLUTION

Abubakr O. Nur*, Alharith A. A. Hassan, Elrasheed A. Gadkariem, Zuhair Osman, Gamal K. M. Ali

ABSTRACT

Background: The use of co-amoxiclav injectable form among neonates and infants necessitates the usage of a part of the reconstituted drug solution or suspension, based on the relative low weights of this group of patients, with the remaining part of the reconstituted form being discarded and not used for subsequent doses due to unreliability in dosage form stability. This practice increases the cost of the treatment. Objective: This study aims at evaluation of the stability of reconstituted co-amoxiclav injectable solutions in order to use it in the most cost-effective manner. Methods: Physical, chemical and microbiological stability of reconstituted co-amoxiclav injectable solutions were evaluated at 4 different storage conditions which assembled by iterating each of temperature and lighting condition at two possible levels. Responses measured were degradation rate, colour and pH changes, shelf life and sterility of reconstituted drug solutions. Results: Degradation of both Clavulanic acid and Amoxicillin was found to enhance with increasing of storage temperature whereas only the degradation of Clavulanic acid appeared to be affected by storage light conditions. Time dependent changes in colour and pH were observed in reconstituted solutions under all storage conditions, especially in samples stored at 30˚C in indoor room lighting. Best storage conditions for reconstituted co-amoxiclav injectable solutions was determined as refrigerated at 4-8˚C in dark with associated shelf life of 1 hour. All reconstituted solutions complied with the test for sterility. Conclusions: Reconstituted co-amoxiclav injectable solutions should either be used immediately after reconstitution or within a maximum of 1 hour of reconstitution if stored protected from light at 4-8˚C.

Keywords: Co-amoxiclav, injectable solution, stability, shelf life, sterility.