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Brief Overview of Development and Characterization of Herbal Products
Published in Anil K. Sharma, Raj K. Keservani, Surya Prakash Gautam, Herbal Product Development, 2020
Andrew G. Mtewa, Lucrece Ahovegbe, Tamirat Bekele, Ibrahim Chikowe, Fanuel Lampiao
Herbal product development and characteristics are a set of processes undertaken in the designing, standardization, manufacturing, and validation of a herbal product’s readiness for the market. The development of a botanical drug involves the collection and authentication of both materials and tools used at every step of the process. These amount to the evaluation of botanical, phytochemical, pharmacological, and pharmacognostic aspects of a botanical drug product and its standardization (Lee, 2002; Sardana, 2012).
Drug Products with Multiple Components—Development of TCM
Published in Shein-Chung Chow, Innovative Statistics in Regulatory Science, 2019
Although the use of TCMs in humans has a long history, there have been no regulatory requirements regarding the assessment of safety and effectiveness of the TCMs until recently. For example, both regulatory authorities of China and Taiwan have published guidelines/guidances for clinical development of TCMs (see, e.g., MOPH, 2002; DOH, 2004a, 2004b). In addition, FDA also published a guidance for botanical drug products (FDA, 2004). These regulatory requirements for TCM research and development, especially for clinical development are very similar to well-established guidelines/guidances for pharmaceutical research and development for Western medicines. It is a concern whether these regulatory requirements and the corresponding statistical methods are feasible for research and development of TCM, based on the fact that there are so many fundamental differences in medical practice, drug administration, and diagnostic procedure. As a result, it is suggested that current regulatory requirements and the corresponding statistical methods should be modified in order to reflect these fundamental differences.
Phytopharmaceuticals
Published in Dilip Ghosh, Pulok K. Mukherjee, Natural Medicines, 2019
We believe that, with this notification, a new route for drug development has been opened that can actually be a sunrise sector for the Indian Pharmaceutical industry and the various national research laboratories and academic institutions. This can happen while Ayurvedic medicines also flourish. The authors suggest not only bringing awareness of this regulation to various stakeholders, but also promoting training and discussion around phytopharmaceutical drug development. The regulations provide protection to traditional medicines, but also promote botanical drug development.
Cannabis and cannabinoid drug development: evaluating botanical versus single molecule approaches
Published in International Review of Psychiatry, 2018
Marcel O. Bonn-Miller, Mahmoud A. ElSohly, Mallory J. E. Loflin, Suman Chandra, Ryan Vandrey
One of the key tenets of modern medicine is that one must be able to define medications chemically to the highest degree possible. A botanical drug such as cannabis requires definition of its chemical profile and the ratio of all components to one another. The ability to fully characterize, define, and demonstrate consistency in chemical composition is one of the greatest challenges to botanical drug development. This requires highly regimented and controlled agricultural practices under conditions that would guarantee consistency in the chemistry of the final product, be it raw plant material or manufactured extracts. It also requires that the developer be able to select a single variety of cannabis, or chemovar, for which to evaluate efficacy for a specific health condition. Due to interactions between constituent chemical components of the cannabis plant, a positive clinical outcome for one defined botanical cannabis product cannot be generalized to other chemovars, or to cannabis more broadly. Similarly, lack of efficacy for one cannabis chemovar cannot be used to establish lack of efficacy, because the interactive effects of individual components of the botanical may negate effects that would otherwise be observed if cannabis with a different chemical profile was utilized.
How can we improve the safe use of herbal medicine and other natural products? A clinical pharmacologist mission
Published in Expert Review of Clinical Pharmacology, 2020
Elena Y. Enioutina, Kathleen M. Job, Lubov V. Krepkova, Michael D. Reed, Catherine M. Sherwin
Botanical drugs are often extracts prepared medicinal plants, algae, and/or macroscopic fungi (Figure 1) [4]. Highly purified or chemically modified NP constituents are not considered to be botanical drugs and are classified as conventional drugs. The pharmacological properties of a botanical drug cannot always be ascribed to a specific constituent. Furthermore, the pharmacological effects of botanical multi-constituent drugs are most likely the result of the combined activity of all constituents present in the extract. Specific recommendations for botanical drug production, safety, and efficacy testing were clarified in a ‘Guidance for Industry: Botanical Drug Products’ initially published by the Center for Drug Evaluation and Research Botanical Review team in 2004 and revised in 2016 [1,5]. The U.S. FDA has received > 800 IND and PINDs in the last 34 years [5]. The marketing of botanical drugs is labor-intensive and expensive [5,20]; therefore, only two botanical drugs have currently fulfilled the directives given in the Guidance for Botanical Drugs (i.e. Veregen® (sinecatechins) ointment and Mytesi® (crofelemer)) [2,5]. Veregen® (sinecatechins) is a water extract of green tea leaves from Camellia sinensis (L.) intended for the cutaneous treatment of external genital and perianal warts in immunocompetent patients aged ≥18 years [21]. The extract consists of eight known catechins (i.e. Epigallocatechin gallate, Epicatechin, Epigallocatechin, Epicatechin gallate, Gallocatechin gallate, Gallocatechin, Catechin gallate, and Catechin) and other constituents such as gallic acid, caffeine, and theobromine. Crofelemer is a botanical drug isolated from the red sap of the Croton lechleri tree intended for symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy [22].