Reeta Mandal1, 2, 3
1Nepal Academy of Science and Technology, Lalitpur, Nepal 2Tribhuvan University, Nepal 3CSIR-Indian Institute of Chemical Technology, India
Posters-Accepted Abstracts: J Develop Drugs
For herbal, Ayurdevic and different traditional medicines system in which direct plant materials or its extracts, after standardization, may be used as medicinal agent as such in the form of tinctures or fluid extracts or further processed to be incorporated in definite dosage form such as tablets and capsules, contain complex mixture of many medicinal plant metabolites, such as alkaloids, glycosides, terpenoids, flavonoids and lignans lead to good products. Even in these medicine formulations Good Manufacture Practices (GMP) via Good Laboratory Practice (GLP) leads in quality product. In natural product chemistry, an extract are further processed through various techniques of fractionation to isolate individual chemical compounds from natural products. In any natural product isolation program in which the end product is to be a drug or a lead compound, some type of bioassay screening or pharmacological evaluation must necessarily be used to guide the isolation process towards the pure bioactive component. For example, one successful story of taxol production by Hause chemical research for National Cancer Institute (NCI) 1989 via CRADA which was awarded to BMS via GMP for clinical uses. The BMS became source of bulk taxol for clinical and commercial, have reported commercial scale 16000 lb to 13000 lb of bark of Taxus brevifolia to produced 1 kg taxol and 3.2 million have collected for 200-246 kg taxol in 1992. BMS have delivered 16 kg taxol to formulate in vials for human use for 8000-10000 people affected by Cancer. FDA, USA approved that bark of Pacific yew, T. brevifolia use for taxol production under Act, 16, U.S.C.4801-4807(1992), later New Drug Application (NDA) also approved it. Nowadays, hot sale GMP certified 100% pure natural taxol US $ 1-1200/Kg. Similarly, vincristine and vinblastine from the Madagascar periwinkle, Catharanthus roseus G. Don, introduced a new era of the use of plant material as anticancer agents. They were the first agents to advance into clinical use for the treatment of cancer. Vinblastine and vincristine are primarily used in combination with other cancer chemotherapeutic drugs for the treatment of a variety of cancers, including leukemias, lymphomas, advanced testicular cancer, breast and lung cancers, and Kaposi�s sarcoma. These successful stories happen possible due to GMP via GLP from Natural Product Chemistry Laboratory to Pharmaceutical Industry. Integrated Natural Product Chemistry Laboratory and Pharmaceutical Industry Laboratory with GLP for GMP lead to quality product. Based on GLP manufacturing will lead to be GMP for active drugs in Pharmaceutical Industry result in quality products.
Email: ritamandal201@gmail.com
