Evaluation of the quality of 500mg paracetamol tablets dispensed in the formal sector of the city of Ndjamena

Introduction. Ensuring the quality of medications, whether they are produced   locally or imported, is an essential pillar of any healthcare system. Quality control tests ensure that products comply with pharmaceutical standards and thus protect patients from the risks of adverse effects or therapeutic failure.

In Chad, the circulation of counterfeit medications persists even within the official supply chain, amplifying the threats to public health. This work aims to evaluate the quality of 500 mg paracetamol tablets marketed in the formal circuits of the city of N'Djamena.

Materials and methods. We conducted an experimental study lasting 6 months using as a reference the standards of the European Pharmacopeia 8.0 IV th edition and the American 37NF32. The samples from different batches were selected using a non-random method in the city of N'Djamena. The pharmacotechnical tests conducted concerned labeling, visual inspection, hardness, disintegration, friability, mass, and dimensions. The physicochemical tests focused on the identification and quantification of the active ingredients.

Results. Three (3) come from Africa, which is a rate of 15%, eight (8) come from Asia, which is a rate of 40%, and nine (9) come from Europe, which is a rate of 45%. The non-conformities found were:  hardness (65%), friability (15%), labeling 7 lots (40%), approval (15%), and principal dosage. The compliant parameters were Disintegration, mass uniformity, principal identification, and sizing.

Conclusion. Out of all the batches analyzed, 16% were declared non-compliant and 84% were compliant with the analyzes. These non-conformities can be due to a manufacturing defect, the failure of the quality assurance system, and sometimes intentional malpractice by certain laboratories. All these non-conformities expose the population to therapeutic failures, deaths, worsening of existing pathology, therapeutic adherence problems, and the emergence of fever resistance phenomena.