J Pharm Pharmacogn Res 3(suppl. 1): S153, 2015
Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015 September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.
PCT-61: PHYTODRUGS DEVELOPMENT AND ITS CLINICAL APPLICATIONS
One of the main aims of the pharmaceutical industry is developing drugs for quality, safety and efficacy. In Chile herbal medicines are officially recognized; its inclusion in the therapeutic arsenal, either to prevent, mitigate disease or as adjuvant in different treatments, it remains a major challenge. Developing a phytodrug requires: 1) knowing the therapeutic objective will fulfill that must be previously studied, 2) quality, homogeneity and reproducibility of raw materials (vegetable), 3) standardized extracts that have the support of pharmaceutical technology to ensure product quality and reproducible certified. Moreover, the manufacture of phytodrugs must comply with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), have a quality assurance program and to comply with existing legislation (DS 03/10), which requires between other validation both production processes and analytical methods. Once formulated the phytodrug, it must comply rigorously, like any other synthetic drug, preclinical, toxicological and clinical studies (Phase I, II, III). These studies provide evidence of therapeutic activity and test the efficacy and safety. These studies provide evidence of therapeutic activity and test the efficacy and safety of using the phytodrug. Post-market monitoring of the drug through the pharmacovigilance is necessary, in order to collect and record notifications of possible adverse drug reactions (ADRs). This long process is exemplified with the product “MATIMEL”, which is active extract BG-126® Patent Office Nº8852654 parts and USA brands, “Use of a standardised dry extract of leaves of Buddleja globosa Hope, BG126, for the treatment and prevention of gastrointestinal disorders caused by treatment with nitrofurantoin and other antimicrobials”.
Citation Format: Barbery S (2015) Phytodrugs development and its clinical applications. [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S153. Abstract nr PCT-61.