THE MICROBIAL QUALITY OF SOME SELECTED ORAL LIQUID PHARMACEUTICAL PREPARATIONS

THE MICROBIAL QUALITY OF SOME SELECTED ORAL LIQUID PHARMACEUTICAL PREPARATIONS

Abstract:

The microbial quality of some commonly prescribed oral liquid preparations namely Paracetamol, Multivitamins and Cough mixtures from three different companies (1, 2, 3; 1, 2′, 3′ and 1, 2″, 3″) obtained from pharmaceutical chemists located within Kaduna and Zaria were analysed during the two prevalent seasons (harmattan and heat) in this part of the country. The analysis involved the determination of the microbial load in the syrups by viable cell counting, determination of pH at the beginning of harmattan season and at the end of heat season, and identification of some of the isolated organisms. The analysed samples were purchased as dispensed by the manufacturers ready for consumer use. The bacteria flora detected include Staph, aureus.. E. coli, and Bacillus species, while the mould/yeast include Aspergillus niger. Aspergillus flavus, Cladosporium Aautianux.. Cladosporiux wernikii.. Penicillium species, Curvularia species, Rhodotorulla species, Mucor, yeast as well as Ascoxycetes species. Generally, the bacterial load was higher during the heat season compared to the harmattan whereas the mould/yeast count were higher during the harmattan season. The bacterial cell count obtained for the Paracetamol syrups ranged from 1.0 x 102 – 6.5 x 102 cfu/ml for the harmattan season and 1.5 – 5.2 x 103 cfu/ml for the heat season. Multivitamins syrups, the bacteria cell count range was 3.5 x 102 – 6.5 x 102 cfu/ml during the harmattan season and 5.0 x 103 – 6.5 x 102 cfu/ml during the heat season. The Cough syrups had a count range of 1.0 x 102 – 1.2 103 cfu/ml during harmattan season and zero 2.6 x 103 during the heat season. For the mould/yeast, however, the count obtained for Paracetamol syrups ranged from 0.5 x 102 spu/ml during the harmattan and 0.2 x 102 – 4.5 x 102 spu/ml during the heat season. For Multivitamins syrups, the count ranged from 3.0 – 7.0 x 102 spu/ml during harmattan season and 1.0 x 102 – 5.5 x 102 spu/ml during the heat season. The Cough syrups had a mould/yeast count range of 1.0 x 102 – 1.0 x 103 spu/ml during harmattan and 0.1 x 102 – 7.5 x 102 spu/ml during the heat season. However, there were batch to batch differences recorded as three different batches from each company were analysed. The pH at the beginning of the analysis (harmattan season) were mainly on the acidic level and this shifted towards the alkaline level at the end of the period of analysis (heat season). It was observed that the microbial load was not directly associated with changes in pH. The result of this work has demonstrated that, the samples analysed actually contained microbial contaminants right from the manufacturer and that the seasons do affect the microbial load due to the changes that occur in the storage temperature and the resulting effect of this microbial contaminants may lead to spoilage as well as unacceptability of products and subsequent health hazards on the consumers. Therefore, there is the need for manufacturers to adhere strictly to good manufacturing practices, and good storage facilities should be provided in each pharmaceutical premises.

THE MICROBIAL QUALITY OF SOME SELECTED ORAL LIQUID PHARMACEUTICAL PREPARATIONS

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