Panel discussion on...
Raw material selection and extraction process optimization
for high-quality botanical extracts:
challenges and opportunities in a growing market
Raw materials strongly affect botanical extract quality. In order to guarantee the best botanical extract, raw materials have to be selected following strictly and specific requirements, starting from the botanical variety, the part of plant used up to the production flow chart (which involves sowing and balsamic periods and the use of pesticides).
In this context the quality of the raw materials to be extracted ought to be validated considering 1) the part of the plant selected, since metabolomic pattern could strongly vary between different tissues, and 2) the balsamic period which could strongly affect the composition. Based on this, the analytical techniques which best fit these needs are still HPTLC of HPLC coupled with mass spectrometer.
Both HPTLC and HPLC-MS allow the evaluation of the phytocomplex (following both an untargeted or a targeted approach, based on experimenters needs), and the chromatograms recorded, like an ID picture, could be used to verify both the plant identity and the harvest period. Furthermore, these techniques could be used both on raw material and in the final extract.
Actually, the common trend is the development of extract following a strong targeted approach, looking for only a specific compound.
This approach, of course, allows an easier standardization of the final extract, regardless of the environmental impact on raw material quality; nevertheless, several research works demonstrated that the consumption of the whole phytocomplex often enhances extracts health effects thanks to the synergistic effects of the bioactive compounds. Thus, a potential evolution of the market trend towards the application of not-purified extracts could be predictable, even if the quality and availability of the products would become – as a consequence – even more affected by environmental factors. This possible scenario opens the door to a new and growing research field that aims at the identification of agricultural practices or plant varieties able to face off climate change and suitable for marginal lands, such as camelina sativa (L.) or millet.
Today people are more aware of the potential health benefits derived from the consumption of nutritionally valuable foods than in previous decades; these are clearly recognized as the primary source of bioactive compounds, claimed not only to have a nutritional function but also to improve human health.
Nowadays, the exposure to natural ingredients of botanical nature, particularly through the consumption of food supplements is worldwide increasing and, at the same time, so do consumers’ consciousness and knowledge. This growing trend causes the request of always “greener and safer technologies” up to the exclusion of solvent from the extraction processes.
However, sometimes “solvent-free” doesn’t mean “safer”: botanical ingredients are typically complex mixtures consisting of numerous individual phytochemical constituents and potential contaminants, which composition is strongly affected by the extraction solvent used. Thus, in order to carry out an effective botanical risk assessment analysis it should be considered the effects of the innovative greener procedure applied on extract composition in comparison with the traditional approach.
Following the novel food statements, any changes on the extraction process (i.e., extraction solvent changes) lead to the development of an innovative extract, thus making the traditional use related to the raw material unsuitable and requiring a specific safety assessments.
Nevertheless, innovation in the botanicals field is required. The application of innovative pretreatments and/or extraction processes to optimize extract production assuring a higher quality represent the mandatory step. To reach this goal, stake holders could follow two different strategic paths: 1) bioequivalence assessment, (validation of the innovative extraction process demonstrating the bioequivalence of the so obtained product with the traditional one); 2) safety evaluation (set up of in vitro and in vivo tests to demonstrate product’s quality and safety).
Moreover, based on the abovementioned regulatory issues, technical data sheet and flow chart scheme ought to be attached with all those botanical extracts obtained with innovative extraction procedures, (meaning all processes involving solvents, heating steps or chemical-physical pretreatments which differ from the traditional approach). The technical data sheet must report all the information regarding extract composition, safety test and stability.
Overall, the introduction of an innovative procedure in the production flow chart would require a hard economic effort for the company, thus, in order to guarantee the ROI, the intellectual property should cover both the process and product following the patent regulations.
In my opinion the trend related to number of European extract manufacturers represents a real problem and it lays on two main factors:
- During the last ten years the food supplements market has grown very fast, it is strongly affected by “trends”, and furthermore it lacks scientific based rules/guidelines. In this scenario the always stronger competition has driven the stake holders to invest more and more on marketing rather than on the ingredients, which lost their role and value.
- Globalization didn’t involve global rules, allowing an unfair competition between those producers who can use each kind of solvents and techniques and those who have to follow specific flow charts. However, starting from 2018 these gaps have coming out once at time, starting from contaminants and solvents, finally bringing to a global standardization.
R&D Manager - Bionap
Scientific and Marketing Director - EPO
Head of Scientific Communications & Marketing - Euromed
CEO - Fermedix
R&D Coordinator - FLANAT Research Italia
Data Analyst - FMCG Gurus
CSO - Flytexia
Scientific Manager - Flytexia
Product Innovation and Development Manager - INDENA
Senior Research Manager - INDENA
Junior Product Scientist - INDENA
Medicine Hunter - KSM-66 Ashwagandha
Alessandro Giuseppe Tricomi
Food Supplement Manufacturing - Natural Ingredients Solution
Quality Control - Natural Ingredients Solution
Market Manager, Nutraceutical – ROELMI HPC
General Secretary – S.I.Fit. (Italian Society of Phytotherapy)
Associate Professor in Organic Chemistry - University of Milano-Bicocca
Associate Professor in Organic Chemistry - University of Milano-Bicocca
References and notes
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- Gu Y, Wang G et al., Basic Clin Pharmacol Toxicol 2004; 95(6):295-8.
- Devkar ST etal., J Adv Pharm Technol Res 2015; 6(4):159-64.
- Zhu J etal., Drug Metab Pharmacokinet 2010; 25(5):477- 86.
- Lombardi N et al., British Journal of Clinical Pharmacology, 87(3), 741-753
- Ivanova Stojcheva E etal., Molecules 2022; 27(12):3902.