The Know-how for Production of “Taxotere” an Anti-cancer Drug, Ready to be Turned Over to Industries
By using Taxus baccata , a plant native to the north of Iran, the researchers of Medicinal Plants and Drugs Research Institute of Shahid Beheshti University have produced the anti-cancer drug “docetaxel” with the trade name of “Taxotere”.
Dr. Hassan Rezadoost, a researcher in the production project of docetaxel, an anti-cancer drug, referring to the success of the researchers of Shahid Beheshti University in the laboratory production of active pharmaceutical ingredient (API) in the last three years, said, “In the laboratory phase, this material was produced at gram scales. After the synthesis, the API was produced by chromatographic techniques and assessed by one of the valid assistant laboratories of the Ministry of Health and Medical Education.”
Regarding the results of the evaluation he stated, “Based on the evaluation results, the laboratory approved the API, and considered it to be the equivalent of the imported drug, ‘Taxotere’, from the drug master file (DMF) point of view.”
This researcher highlighted that medicinal plants are the main basis of this API and explained, “This drug is semi-synthetic, which means the active compound is extracted from the medicinal plant and is synthesized in 6 steps into the desired end-product.”
Rezadoost added, “semi-synthesis is an important issue in chemistry, since using this method, the invaluable compounds can be extracted from the medicinal plants and they can be turned into a product with multiplied value added.”
He went on to say, “At the beginning of the implementation of this project, the starting material of this anti-cancer drug was imported from abroad; however, with further studies we succeeded in producing that in Iran, and the 100 percent of the material that was produced as a drug was extracted from Taxus baccata at laboratory scale.”
This faculty member of Medicinal Plants and Drugs Research Institute of Shahid Beheshti University stated that the medicinal plant used in this drug material has the scientific name of ‘Taxus baccata’ and is grown on the Caspian coastline all the way to the west and east Azerbaijan.
Rezadoost pointed out that the active compound is extracted from the leaves of this plant and that it is purified in the laboratory. Furthermore, they were able to extract the active compound for ‘Taxotere’ drug by tissue culture of Taxus baccata.
He added, “The method of extracting the active compound is in a way that after getting the desired chemical from the plant, the plant stays in the soil without being damaged.”
This researcher of the production project of ‘Taxotere’ an anti-cancer drug, asserted that the researchers of Medicinal Plants and Drugs Research Institute of Shahid Beheshti University have achieved the know-how for the production of this drug and that the continuation of the large scale production of this drug requires some infrastructures such as advanced Cleanrooms. Therefore, the research institute has announced their readiness to turn over the know-how of the drug to the pharmaceutical companies.
According to him, ‘docetaxel’ is one of the most expensive and widely used drugs for the treatment and control of ovaries, prostate, breast and lung cancer.