Investigation of technical complaint of azitromycin powder for oral suspension distributed by Unique Health System

Abstract

Azithromycin is a broad-spectrum antimicrobial, indicated for treatment
of respiratory tract infections, skin and soft tissue infections, and sexually
transmitted infections. The Núcleo de Ensaios Físicos e Químicos em
Medicamentos of the Adolfo Lutz Institute receives samples of medicines
collected by the Sanitary Surveillance to be evaluated for their quality.
The objective of this study was to describe the analytical results of
five different batches of azithromycin 200mg/5mL, powder for oral
suspension, from the same manufacturer, distributed by the public health
system and received by IAL from 2016 to 2017. In order to answer the
technical complaints regarding the presence of lumps in the powder and
in the suspension, it was considered relevant for the research the aspect
tests, determination of weight, pH and reproduction of use. The batches
presented results in conformity with the pharmacopoeial specification
for weight determination and pH tests. However these same batches,
but one, presented non-compliance for appearance and reproduction of
use. The non-compliance was demonstrated by the presence of lumps
and by the total volume aspirated below the specified. Thus, in 22 of
the 43 bottles analyzed, it was not possible to extract the three doses
referring to the complete treatment of the drug, compromising its efficacy.
Inappropriate antimicrobial treatment may cause bacterial resistance
development and worsen the patient’s state of health. These results
demonstrate the importance of sanitary surveillance activities for
monitoring the quality of medicines distributed in the public health system,
ensuring that the population receives reliable products