Abstract:
Seven hundred and twenty drug formulations collected
from retail pharmacies and drug stores were analysed.
Three hundred and twenty (44.4%) were syrups and 400
(55.6%) were mixtures. Total viable aerobic count for
the formulations were determined using the plate count
method, and the organisms isolated were identified by
conventional microbiological/biochemical methods.
The study revealed that microbial growth in mixtures
was 49.0% and in syrups 42.8%; however, this difference
was not significant. Different organisms were identified
from the two formulations and their distribution
pattern was found to be significantly different. It was
shown that Gram-negative rods were found only in
mixtures.
Potential pathogens isolated were found more in mixtures
(10.5%) than in syrups (0.3 %). Mixtures of Magnesium
trisilicate, Kaolin and Belladona, contained more
potential pathogens as compared to the rest of the
mixtures.
Water used during manufacturing of the formulations was
considered to be the main source of contamination.
Of concern was the presence of potential pathogenic
/
iv
microbes in high numbers. The extreme degradative nature
of the Pseudomonas and many yeast cells isolated should
make one seriously consider the possible degree of drug
destruction.
In view of the above findings, it is recommended that
the authorities responsible for issuing of licences for
drug manufacturing should be more strict, and adherence
to Good Manufacturing Practice (GMP) should be
emphasized. In addition, every manufacturing unit must
have a functioning water purification system, and there
should be frequent inspection of the microbial quality
of locally manufactured drug formulations. Strong
warning should be given for non-compliance and if
necessary legal action be taken.
The findings of this study, provide baseline information
which may be of use in an attempt to improve the quality
of pharmaceutical products and in setting up local
standards in Tanzania.
