Extemporaneous isoniazid mixture: stability implications

Haywood, Alison, Mangan, Martina, Grant, Gary, and Glass, Beverley (2005) Extemporaneous isoniazid mixture: stability implications. Journal of Pharmacy Practice and Research, 35 (3). pp. 181-182.

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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°C) 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 25ºC), 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 ºC).

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.

Item ID: 6655
Item Type: Article (Research - C1)
ISSN: 1445-937X
Keywords: extemporaneous; isoniazid
Date Deposited: 08 Feb 2010 01:02
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1115 Pharmacology and Pharmaceutical Sciences > 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified @ 100%
SEO Codes: 86 MANUFACTURING > 8608 Human Pharmaceutical Products > 860803 Human Pharmaceutical Treatments (e.g. Antibiotics) @ 100%
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