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Drugs from plants – insights into how they are manufactured

Herbal plants suit many people who prefer to take the natural option for their health. Although pharmacologically active plant compounds are often derived from traditional medicinal plants, the way they are processed into the final product has little to do with traditional preparation. Dr. Karin Berger Büter from Vital Solutions Swiss AG develops and investigates new herbal compounds for use in food supplements and drugs using state-of-the-art pharmacological and bioanalytical methods. Herbal drugs are subject to the same strict regulations as synthetic drugs.

Large-scale Coleus forskohlii cultivation in India: the plants are grown under standardised conditions in order to guarantee the constancy of active constituents. © Breeding Botanicals International AG

Extracts from medicinal plants have a long tradition as a way of treating many ailments and are still used today as alternatives to synthetic drugs. In addition to better known medicinal plants like St. John’s wort and sage, there are many more plants whose active constituents can improve health. Cultures in South America, Africa and Asia in particular have traditionally used numerous medicinal plants that are barely known in our latitudes.

Dr. Karin Berger Büter develops and investigates new herbal ingredients for use in dietary supplements and phytopharmaceuticals. She clearly dissociates herself from the commonly held idea that herbal drugs and food supplements have a relatively minor effect or do not do what they promise. “Our work involves the evidence-based development of innovative herbal active compounds, which means that our research is based on the empirically proven effectiveness of such compounds,” says Dr. Berger Büter. The steps involved in the production of herbal drugs from plants, including tests for assessing the efficacy and safety of drugs, are basically the same as those mandated for the production of synthetic drugs. 

Ethnobotany provides information about the suitability of plants as medicinal plants

When researchers develop a new herbal drug, they first look at the indication for which it is to be used. Depending on whether the drug is being developed for the treatment of digestive or cardiovascular symptoms, for example, specific assays are chosen and suitable plants selected. The latter involves a variety of possible approaches. “When we use plants for making food supplements, we make sure we only choose plants that are traditionally used for food,” Dr. Berger Büter says.

Ethnobotany, which is the study of how people in particular cultures make use of indigenous plants, can provide information as to whether a particular plant is reputed as a medicinal plant. In addition, the researchers can also look for plant molecules that are similar to synthetic compounds with a known positive effect. Alternatively, plants can be phytochemically analysed and the potential effects of plant constituents can subsequently be identified using molecular modelling, i.e. computer simulations.

High degree of standardisation despite natural variation

The plant extracts are produced and analysed in the laboratory of Vital Solutions Swiss AG. © Vital Solutions Swiss AG

However, there are quite a few hurdles to overcome with plants used for the production of drugs or dietary supplements. This is down to the fact that their constituents underlie natural variations. “We need to standardise the plants as much as possible, otherwise our product batches will have similar major variations,” Dr. Berger Büter says. Not all plants of a specific species are suitable for the large-scale production of dietary supplements; plant differences also affect the pharmacological activity of a plant extract. 

Therefore, great care must be taken to select a plant with optimal ingredients. Identical offspring is produced so that the effect the harvesting date has on the quality of the extract can be explored and the optimal harvesting time determined. When the sought-after effect, potential active herbal compounds and the right plant genotype have been identified, the plant will be cultivated in order to obtain the required quantity of standardised starting material for subsequent investigations. The method that is best suited for extracting the desired compounds will also be selected at this point.

When the technical details for extracting a plant’s active constituents are in place, the next step is to look at the pharmacology of the plant extracts. Numerous bioassays are carried out to investigate the effect of the compounds. “Some of the bioassays provide information on the potential inhibitory effect a plant extract might have on enzymes, others on the binding of the active compounds to receptors or on their effect on cells,” Dr. Berger Büter says explaining that either recombinant proteins or cell cultures are used for this purpose. 

Identical safety tests for herbal and synthetic drugs

Vital Solutions Swiss AG headquarters in Tägerwilen. © Vital Solutions Swiss AG

The company also examines the absorption of the extracts in the body, their potential toxicity or interactions with other drugs. Moreover, in-vivo studies - behavioural studies in mice, for example - are carried out by partner laboratories. “The bioassays can also produce false-positive results. We need to pay special attention to these, as plant tannins that might be present in the extract may cause unspecific effects due to their ability to bind and precipitate proteins,” Dr. Berger Büter says. In order to exclude such effects, Vital Solutions uses standardised test kits that it adapts and validates to the issue under investigation. 

Many tests need to be carried out in order to test the safety and efficacy of herbal drugs, and are no less strict than those required for assessing synthetic drugs. “New drugs, whether herbal or chemical, need to undergo similar testing procedures,” Dr. Berger Büter says.

Vital Solutions Swiss AG:

Vital Solutions Swiss AG was established in Tägerwilen, Switzerland in June 2013 to develop and commercialise innovative condition-specific natural ingredients for use as phytodrugs, foods, dietary supplements and cosmetics. In addition to being the CSO of Vital Solutions Swiss AG, Dr. Berger Büter is also Director R&D at Breeding Botanicals International AG (www.bb-international.ch), a company that specialises in breeding, propagation, field studies and the large-scale cultivation of bioactive plants.

Further information:

Dr. Karin Berger Büter (CSO)
Vital Solutions Swiss AG
Tel.: +41 (0)71 669 37 81
E-mail: karin.berger(at)vitalsolutions.biz

Website address: https://www.gesundheitsindustrie-bw.de/en/article/news/drugs-from-plants-insights-into-how-they-are-manufactured