The importance of adequate stability testing on the final product in the proposed marketing container cannot be overstated. Batches should be stored at 4°C, 30°C, 40°C and possibly cycling temperature conditions and monitored at regular intervals for appropriate physical characteristics. Chemically, it is suggested that terpinen-4-ol, cineole and oxidation products are monitored and preservative efficacy testing is performed at the beginning and end of the stability study.
Reasons for products failing stability testing are many and varied. Most product failures in the past have been associated with the use of packaging incompatible with the product components and poor stability testing prior to product launch. This has resulted in several unsatisfactory products from a physical viewpoint. Problems which have occurred include panelling of bottles and migration of tea tree oil through pack walls resulting in deformation of external decorations such as label print. Regulatory authorities have given little attention to chemical or microbial activity of formulated products as most of the product claims which have appeared are limited to simple antibacterial claims rather than treatment for specific conditions such as candidiasis or acne. However, as clinical testing on formulated products increases there will be increasing attention to the role of formulation in the effectiveness of tea tree oil for specific conditions. The main points to consider in product failure from a performance point of view are: (1) inadequate packaging, (2) inactivation of tea tree oil by solubilisers, surfactants and other excipients, (3) the grade of tea tree oil used and (4) the method of manufacture including the order of addition of the components.
The inherent anti-microbial properties of tea tree oil are advantageously offered in formulated products. Because of the properties of the constituents of the oil, great care must be taken with solubilisation, formulation, stability and packaging to ensure maximum utilisation of the bioactivity of the oil.
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