Pharmaceuticals in the tropics

: testing for microbial growth and measuring changes in tablets characteristics

  • Bharath Raman Ayyaraju

    Student thesis: Masters by Research - CDU

    Abstract

    Packaging is one of the biggest industries in the world. Global climate change and competition means that the pharmaceutical industry is facing the same challenges as all industries that produce goods for human consumption; providing packaging that keeps their products stable, secure, identifiable from others and attractive to consumers. The world has been divided into four environmental zones based on mean annual temperature and relative humidity. Based upon this data, long-term orreal-time stability testing and accelerated stability testing of the conditions pharmaceutical products are likely to be subjected to during storage have been developed.

    Aim: The aim of this study is to investigate the effect of a tropical environment on pharmaceutical preparations in original and repackaged containers.

    Results: This study concluded that in a tropical environment, medications for immediate release, including those in manufacturers’ containers, undergo significant change in physical characteristics, but a less significant loss of efficacy. Additionally, the study found bacterial and fungal growth inside and outside packages used in repackaging. Some tablets also had surface microbial growth after Week 4.

    Discussion: Storage conditions have not only been standardised, but on some occasions shelf life has been adjusted to account for a certain environment or to suit end users. To improve patient adherence, multiple-dose compartment administration aids (reusable or disposable) are used to alleviate the risk of patients’ non-adherence due to the complexity of chronic disease therapy, poor health literacy or cognitive impairment. Additionally, hospitals dispense between three and seven days’ medication, usually in plastic bottles or bags, as a cost-saving measure. Stability of medications and microbial growth on the solid form of medications (tablets or capsules) when repackaged by someone other than the manufacturer is not guaranteed by the manufacturer.

    Conclusion: This study contributes meaningful data to current practice. Limited studies to date have been carried out in this area, and the process is complex because of the various factors that influence the stability of pharmaceutical products. However, it is an important area for further research because medication should treat a medical condition, not create a new problem.
    Date of Award2017
    Original languageEnglish
    SupervisorPatrick Ball (Supervisor) & Hana Morrissey (Supervisor)

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