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Chemotype Selection and Evaluation
by Christopher J. Robinson
August 2006
RIRDC Publication No 06/090 RIRDC Project No GSD -1A
Executive Summary
What this report is about
This report provides information
on research to facilitate realisation of the commercial potential of a
new essential oil, Agonis fragrans.
Who the report is targeted
at
The report is particularly
targeted at potential investors in the production of agonis oil and potential
users of the product. It will also be useful as a first step in investigation
of the regulatory requirements for the oil.
Background
The oil contained in the
foliage of Agonis fragrans, an erect shrub native to SW Western
Australia, was first recognised as having commercial potential as an essential
oil in 1996. Since then, a market investigation confirmed commercial interest,
but identified a lack of supply as a limitation to further development.
In 2001, The Paperbark Company established a plantation of Agonis fragrans
and is now producing, promoting and selling increasing quantities of the
oil.
Aims
This project aimed to investigate
chemotype variation of the species across its natural range to ensure that
any further commercial development was based upon a suitable chemotype.
The project also aimed to confirm antimicrobial status of the oil, identify
uses and clarify regulatory processes to increase its commercial application.
Methods used
The methodology involved
production and analysis of oil samples from plantations and across range
of natural populations and identification of best or superior chemotypes;
comparative antimicrobial tests; assessment of immunostimulatory ability
for aquaculture; and testing anti-inflammatory ability.
Results
Initial GC analysis of leaf
tissue from 55 plants (five plants from each of eleven wild populations)
indicated some variation in constituents. The major variation was two plants
in one population which contained no 1,8 cineole, which was present as
a major constituent in all other plants. Preliminary GC analysis was used
to select six plants for leaf tissue GCMS analysis. This investigation
showed the variation in constituents was not unusual (apart from the no
cineole sample). At least two varieties were considered suitable for further
investigation and commercial development.
In-vitro studies conducted by UWA Microbiology confirmed that Agonis fragrans oil has significant anti-microbial activity, similar to that of other recognised anti-microbial essential oils, including tea tree oil (from Melaleuca alternifolia) and that it may have clinical potential as an antimicrobial agent.
These studies indicated that there was no significant variation in results between the oils tested, which however did not include the no-cineole sample which was unable to be tested. It does confirm that the chemotype currently being produced and marketed is at least equal to any other.
In-vitro studies conducted by the School of Paediatrics and Child Health, University of Western Australia, found that Agonis oil inhibits secretion of the IFNã, involved in inflammatory response to tissue injury or infection, which could support the notion that this oil potentially has anti-inflammatory properties. However more studies are required, in particular to determine the effects on other cell types such as neutrophils and purified macrophages, important in inflammatory immune responses as well as safety issues.
Implications
During the course of this
project, significant commercial developments between the industry partner,
The Paperbark Company and international interests have emerged. Extensive
clinical trials to support a commercial launch of Agonis fragrans
oil are now being conducted on behalf of a core commercial development
group, and may confirm a range of reported clinical uses such as remedial
therapies for joint, muscle and arthritis pain and respiratory infections.
Research (by the core commercial development group) is also being undertaken
into the likely emotionally balancing activities of the oil, possibly due
to the inherent balance of the major constituent groups.
The regulatory overview undertaken as part of the project has given a clear path to the regulatory process required to establish Agonis fragrans oil as a new chemical entity. The Paperbark Company is already using this report as a guide through appropriate processes.
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