Pharmabiz
 

Green extracts: present trend & future challenges

R.RajendranThursday, December 15, 2011, 08:00 Hrs  [IST]

Business of green extracts is a fast growing one and is attracting many companies to  diversify into this area. However an emerging  challenge is how best the safety can be assured to  the consumers.

The Indian knowledge on herbal medicines is abundant. Using this in a scientific format similar to pharmaceutical concept is very essential for us to succeed in the international arena. For achieving this, we should know what are the present weakness in herbal extracts area.

Ayurveda recommends use of crude herbs powders, tinctures, churnas, crude extracts etc. These are  not having any quality standards, as Ayurveda has  not prescribed the required standards. Herbs collected from south can  vary in quality as compared to other parts of India. Herbs collected from wild can have a  different quality as compared to cultivated herbs in same region. The time of harvesting, the mode of drying the herbs, the mode of storing herbs can also make a big difference in ultimate quality, prior to consumption.

There are many factors which can affect the quality with respect to the content of active phytocompounds present in the herbs. Turmeric is a good example. The content of Curcuminoids in Salem Turmeric is about 6-8 per cent , the highest. Erode turmeric contains 2-3 per cent only.

Turmeric from Kerala, North, Maharashtra, varies in content of Curcuminoids. This is common for almost all herbs.

Species identification can also pose a problem in achieving desired quality. Two species of the herb looking alike can be misused if it is collected by visual inspection only. Sage, Tulsi, Mint, Rose are few examples. This type of similarities is sometimes exploited to adulterate the herbs.

All these result in consumption of wrong herbs or low potent herbs, leading to health problems to consumers. Therefore the challenge is on how to offer the herbs which are consistent in quality with respect to end results.

The same is applicable when we use herbal extracts if the extracts are not tested for quality with respect to active substances, biological contaminations, physical contaminations, chemical impurities, toxicity, stability etc. The quality of herbal extracts can also vary depending upon how it is extracted, what extraction medium is used, what compounds are getting extracted, toxic compounds are also co-extracted or eliminated and so on. If the herb contains 20 active compounds, all 20 are getting extracted or only few are extracted? What is the activity of the enriched extract?

Sometimes the active compounds can get damaged during extractions. The degraded products can be toxic in some cases. The stability of the extracted product can be a problem as compared to native herbs.

All these questions can be answered and tackled scientific manner if we follow pharmaceutical approach for ensuring quality consistency for the product, it may be the raw herb or the enriched product or a selectively purified product or a semi synthetically modified product.

We should establish standards for each of the above to assure the expected bioactivity to the consumer.

Each herb and each green extract should be studied in depth to specify quality standards, covering impurities relating to physical, chemical, biological in addition to purity parameters, similar to Pharmacopeial products. This should cover the dosage, expiry dating, compatibility parameters in multiple ingredients formula as well.

Product specifications should cover the botanical name, part of herb extracted, ratio of extract to herb, solvents used, excipients and carriers used, description, identification by HPTLC finger printing, moisture, solubility, pH in water solutions, ash content, active compounds levels by HPLC using reference markers, quantification of other compounds, microbials including pathogens, heavy metal profiling, residual solvents , residual pesticides, any other organic volatile impurities, aflotoxins, any possible presence of chemicals by spiking and few others as well.

Synthesis of plant chemistry will help in making a pure standard which can be used analytically as reference standards for estimation of actual content of this particular compound in the herbal product. This will enable the manufacturers to manufacture herbal extracts with consistent quality batch after batch. This is the need of the hour today as reference standards are not much available for herbal compounds.

It is important to specify packing details ( it is important to use double, virgin food grade polythene bags), storage conditions and stability period. Safety of the Green extract should be ensured by animal studies. Toxicity study should be carried out elaborately covering acute oral toxicity, mutagenicity and sub-chronic toxicity and teratogenicity .

Product development should include all above stages to ensure Green extracts are safe for consumption. This is a bigger challenge for all of us to realize and set an example to others internationally.

A recent trend proves Indian companies are far better and competitive for offering good safe green extracts. Many foreign companies look towards Indian companies for conducting clinical trials, toxicity studies for both green extracts as well as medicinal substances. This shows the capabilities available in India which is a major advantage  for  us.

AYUSH dept has already started developing monographs for herbs and herbal extracts  involving many Indian companies. Green Chem, Bangalore is also a part of this.

The interest shown by Indian pharma giants for formulating herbal ingredients is also proving our efforts towards achieving many milestones in the international arena.

Ayurvedic knowledge and traditional usage information are excellent, but using these in a scientific way incorporating pharmaceutical approach will be more meaningful to ensure safety of the consumers.

Green extracts have certain limitations in giving quick results as compared to synthetic allopathic chemicals. For example anti diabetic chemicals like metformin, glimepiride and others show quick results in reducing blood sugar levels. When we use herbal extracts like karela, gymnema, coccinia, mulberry etc, sugar reduction is not as good as the above chemicals. Even higher dosages cannot achieve better results. Now the challenge is how to make use of herbals along with synthetic medicines. Complimentary medicines are the new approach, being attempted to get the benefits of both.

Using synthetic drugs to reduce the sugar levels to normal level and then taking herbal extracts to maintain the sugar levels is the new approach. Herbs can give a lot of variety and flexibility in usage. Gymnema herb is an anti - diabetic herb. The mechanism of working is unique! This is to be taken before a meal so that the Gymnemic acids present in Gymnema, obtunds sugar identifying receptors temporarily when the sugar is passing through  the alimentary canal. Therefore entry of sugar into blood stream is limited. Taking Gymnema before meal and taking other herbal extracts after the meal can regulate sugar levels. Green Chem is promoting this concept with DiaBef and DiaAft for sugar control.

Herbal extracts can work better at a different platform as compared to drugs. Synthetic Drugs can help in controlling the disease and thereafter herbal extracts can take over to maintain the effect. The inter phase has to be gradual to avoid imbalance due to sudden abrupt change over. By this way long use of synthetic drugs can be minimized with lesser side effects.

A combination of a synthetic pain killer with prawn shell-Glucosamine and Cardiospermum extract, Delonix extracts etc, can give a faster cure for arthritic conditions. We have seen miraculous results with  Green Chem’s unique formula. This approach is poised  to give a major breakthrough in health recovery segment.

Ischemic conditions are the reasons for many ailments due to improper blood circulation. Blood circulation is most important to nourish parts of human body. If this not proper the respective function is affected. The circulation can be affected by various reasons – fat deposits, capillary hardening, low pressure etc.

Most of the ailments are caused by insufficient blood circulation. We are working on various herbal ingredients to tackle the ischemic conditions. This will be a major area of our focus for next few years.

Another major focus in the international market is using green extracts for enhancing male libido/ female libido and reducing  obesity . This has been established by Green Chem and products are exported to the  US, Australia and other countries.

Application of herbal extracts  have already  gained ground in  herbal shampoos, herbal conditioners, herbal hair colours, herbal scrubs etc. Green Chem has developed herbal extracts for anti acne, skin whitening and hair fall stopping. This is a bigger area where the green extracts can be used  effectively.

Another very important area is using organic herbs and organic herbal extracts. Organic cultivation does not use any chemical pesticides, chemical fertilizers and other chemicals. Therefore it is  safe for consumption. But there is a difference between organic herbs and certified organic herbs. We should insist on certified organic herbs so that the organic cultivation is genuine and authentic. Since the certification is done by an outside reputed agency,there is no room for errors and hence the consumer is safe.

One more area to be watched  is the synthesis of phytocompounds using chemicals. Chemical synthesis is well advanced  in India and abroad. When we use these fully synthesized or semi synthesized phytocompounds, it is essential to scientifically validate the safety and efficacy of these compounds. These synthetic and semi - synthetic chemicals should be treated as new molecules and the drug testing should be elaborately done to prove they are safe for human consumption.

The scope for using herbal ingredients is very big. It is important to establish the safety and efficacy first and then market. In India we have the herbal wealth and good brain power. Let us be the global trend setters .     

The author is founder & CEO,
Green Chem and founder & CEO, Natsyn Catalysts

 
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