Study of the microbiological stability of a pediatric oral solution of paracetamol, after introduction of the dosing pipette for 5 days of use

In Morocco as in other countries around the world, the galenic form most used for the administration of paracetamol in children is the syrup form, most often accompanied by an administration device "dosing pipette" also called "dose pipette -weight” which is presented in the form of a graduated syringe, in units corresponding to the weight of the child in kilograms (Kg). The primary

In the present study, we are interested in the effect of the use of dose-weight pipette dosing devices on the microbiological stability of the oral solution after opening. This concerns in particular the effect of opening and frequent introduction of this pipette into the medicinal product during its use during treatment.

For this study we used an oral pediatric paracetamol solution, we simulated the use of this solution, by taking 4 doses every 6 hours, for 5 days (average duration of a febrile state), using the dosing pipette provided. The microbiological contamination of the solution was systematically tested immediately after opening (control) over a period of five days after daily introduction of the pipette (every 6 hours). At the same time, we carry out the same simulation, with another bottle of paracetamol of the same brand. The bottle will be kept in a refrigerator at a temperature between 2° and 8°, after each introduction of the dosing pipette, unlike the first simulation. In accordance with the specifications described in European Pharmacopoeia monograph 2.6.12. A 1:10 dilution of the product was prepared using a buffered sodium chloride-peptone solution at pH 7.0. More precisely, for each sample, 2.5grams were weighed and diluted according to the protocol prescribed in European Pharmacopoeia.

Based on the results of the study, the health risk associated with the use of the pipette was identified mainly in terms of microbial contamination by staphylococci. Thus, in accordance with the specifications of the European Pharmacopoeia, the microbiological quality is judged to be non-compliant for the solution used for a simulation of use for 5 days.

This study therefore underlines the importance of taking into consideration during stability studies after opening, of these pharmaceutical forms, in general, the impact of the frequent introduction of "dosing pipette" type devices as well as compliance with the rules for using this type of device in particular, cleaning and storage instructions.