Stability of Reconstituted Amoxicillin and Potassium Clavulanate Oral Suspensions Marketed in the Democratic Republic of the Congo

Abstract

Amoxicillin and Clavulanate potassium oral suspensions are one of antibiotics combination mainly available as dry powders for reconstitution. Made of a β-lactam molecule with a β-lactamase inhibitor, this combination existence can be justified by the potency of Clavulanate potassium which protects Amoxicillin against bacteria producing β-lactamases. Once reconstituted, suspension in single dose bag need to be taken by patient on daily basis following the medical prescription and the one in bottle to be taken according to the medical prescription and the remaining part (in the same container) kept refrigerated in order to get the optimal benefit from the drug. This study investigated the stability of Amoxicillin and Clavulanate potassium suspension both in bags (sachets) for single dose per daily-usage and in bottles for multiple dose usage. The last were reconstituted using distilled water and stored in refrigerator and the previous were instantly reconstituted before measurement. The stability evaluation was conducted on three brands (Six samples totally, two per brand including bottle and sachet for each brand) and for duration of seven days using a validated HPLC method. The evaluation was based on the measurement of pH values, color observation of reconstituted suspensions stored under refrigerator during 7 days and the active compounds concentrations determination. After analysis, no change was observed in pH values and a small change of color for multiple dose presentations stored in refrigerator. And the concentrations of suspensions evaluated in day 1 and day 7 showed over 90% up to seventh day under same storage conditions for both of the Amoxicillin and Clavulanate potassium pharmaceutical presentations. As the study aimed to assess the stability of the suspension in single-dose from bag presentation and in multiple-dose from suspension in bottle, we observed that the reconstituted suspension in distilled water of Amoxicillin + Clavulanate potassium stored in refrigerator is stable for seven days of use, independently from their pharmaceutical presentations either for oral suspensions (powders) in bottles or those in bags for single use after reconstitution.