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  • Extemporaneous Isoniazid Mixture: Stability Implications

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    Author(s)
    Haywood, A
    Mangan, M
    Grant, G
    Glass, B
    Griffith University Author(s)
    Haywood, Alison
    Grant, Gary D.
    Year published
    2005
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    Abstract
    Background: Isoniazid mixtures are compounded in Australia using commercially available isoniazid tablets. Aim: To determine the stability of isoniazid 10 mg/mL mixture compounded from commercially available isoniazid tablets. Method: The stability of the compounded isoniazid mixture stored at a range of temperatures (4-60 é was assessed with high performance liquid chromatography. Differential scanning calorimetry was used to investigate the compatibility of isoniazid with the excipient, lactose. Results: The compounded isoniazid mixture exhibited significant degradation (= 10% after 3 days at 4 and 25 ꃩ, whereas the ...
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    Background: Isoniazid mixtures are compounded in Australia using commercially available isoniazid tablets. Aim: To determine the stability of isoniazid 10 mg/mL mixture compounded from commercially available isoniazid tablets. Method: The stability of the compounded isoniazid mixture stored at a range of temperatures (4-60 é was assessed with high performance liquid chromatography. Differential scanning calorimetry was used to investigate the compatibility of isoniazid with the excipient, lactose. Results: The compounded isoniazid mixture exhibited significant degradation (= 10% after 3 days at 4 and 25 ꃩ, whereas the control (using isoniazid powder) retained desired stability (> 90% at 30 days) under identical conditions. A replicate control formulation, spiked with lactose, produced statistically similar degradation profiles to that of the compounded isoniazid mixture (p > 0.05), indicating lactose to be responsible for the degradation of isoniazid. The thermoanalytical studies demonstrated an incompatibility between isoniazid and lactose (broadening and shifting of melting endotherm of isoniazid at 171.46 ꃩ. Conclusion: The British Pharmaceutical Codex specifies the use of isoniazid powder for compounding isoniazid mixture. This study highlights the importance for stability evaluations on all modified extemporaneous preparations in order to ensure that quality pharmaceuticals are delivered to patients.
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    Journal Title
    Journal of Pharmacy Practice and Research
    Volume
    35
    Issue
    3
    Publisher URI
    https://onlinelibrary.wiley.com/doi/10.1002/j.2055-2335.2005.tb00333.x
    DOI
    https://doi.org/10.1002/j.2055-2335.2005.tb00333.x
    Copyright Statement
    © 2005 Journal of Pharmacy Practice and Research. The attached file is reproduced here in accordance with the copyright policy of the publisher.
    Subject
    Pharmacology and pharmaceutical sciences
    Publication URI
    http://hdl.handle.net/10072/4835
    Collection
    • Journal articles

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