Abstract

Recently, the manufacturers of pharmaceuticals have improved the quality of non-sterile pharmaceuticals in such a way that such products contain only minimal bioburden. However, the production of sub-standard cough syrups and multivitamin syrups may cause non-therapeutic effect in patients, particularly in children. For this reason, this study was conducted to evaluate the microbiological quality of cough syrup and multivitamin syrups marketed in Pokhara, Nepal. Different brands of 15 cough syrups and 15 multivitamin syrups were collected from different vendors of Pokhara and the spread plate technique was performed to enumerate the microbial contaminant from the collected samples. Among 15 cough syrups, 12 samples were found to be contaminated with bacteria and nine samples were found to be contaminated with fungi. Similarly, among 15 multivitamin syrups, 10 were found to be contaminated with bacteria whereas 12 were found to be contaminated with fungi. Escherichia coli was not isolated in any samples. Overall, 14(93.33%) of cough syrup and 13(86.67%) of multivitamin syrups were found to be contaminated by either bacteria, fungi, or by both which exceeded the acceptance limit of International Pharmacopeia. The prevalence of these microorganisms in pharmaceutical products such as syrups samples may indicate the unhygienic condition, defect in production, poor adoption of Good Manufacturing Practice, ineffective preservatives and inadequate quality control. Though these products fall under non-sterile pharmaceutical products, so they need not require sterility but these drugs must conform to the microbiological purity criteria set in the appropriate pharmacopeial standard. These contaminated syrups explain the poor treatment and complicacy of the uncompromised people and the sick children.

Highlights

  • Pharmaceuticals are used for the purpose of prevention, treatment and diagnosis of diseases (Denyer et al, 2004)

  • The bacterial contamination of syrup and suspension can cause the spoilage of the products and lead to serious clinical hazards in children and elderly people (Takon & Antai, 2006)

  • In this study, the results showed that the samples tested had unsatisfactory total microbial count levels compared to the International Pharmacopoeia IP (2019) specification

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Summary

Introduction

Pharmaceuticals are used for the purpose of prevention, treatment and diagnosis of diseases (Denyer et al, 2004). Pharmaceutical products can be divided into two groups; sterile and non-sterile. Non-sterile pharmaceutical products are not required to be sterile, but are subject to certain restrictions on the number and types of acceptable microorganisms to make sure their efficaciousness and safety (Jimenez, 2004). Syrups are the non-sterile liquid dosage form that contain active medicaments and constitute the most convenient dosage form for babies, children and the elderly. They are generally prepared for oral administration in children since tablets and capsules cannot be or suitably administered to them. The administration of contaminated syrups to these people pose a real danger, even at low levels of contamination because their immune system is poorly developed (Mendie et al, 1993; Muhammed & Umoh, 2009)

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