Diversity, Utility, Analytical Methods and Use Implications of Aroma-active Compounds from Select Angiosperm Familie.

Introduction: An “aroma-active compound” (AAC) has a “flavor”- ie: a “distinct taste and odor”. An example is menthol. All aromatic plants (APs), including some medicinal plants, such as Mentha×piperita (Family Lamiaceae), produce a group of fat-soluble secondary metabolites called “essential oils” (EOs) for various ecophysiological reasons. An EO has a “flavor” because it contains one or more AACs. A typical EO is a complex mixture of several AACs, with wide ranging, dose-dependent pharmacological/ toxic effects. Owing to their complexity and variability, many EOs need to be standardized to ISO’s criteria. Professional use of EOs/ AAPs in food and drugs is controlled by good manufacturing practice (GMP). Aim: Given the immense diversities in sources, chemical structures, and bioactivities of EOs/ AACs, which are greatly patronized in foods and drugs, this review focused on their: i) sources in plants, beneficial attributes and liabilities; and ii) chemistry and analytical methods, in order to gain a better insight into their regulation in foods and drugs. Methodology: Using the 2009 Angiosperm Phylogenic Grouping (APG) of plants as a guide, pertinent literature was perused to ascertain: i) the taxa of APs; ii) their EOs/ AAPs; and iii) the methods for analyzing EOs/ AACs in raw materials (RMs) and finished products (FPs). Results: The literature revealed scores of AACs with varying health implications. But their levels in samples are usually unknown, or extremely hard to ascertain, owing to costs and complexities of the methods used. Conclusions: Given the wide ranging effects of EOs/ AAPs vis-à-vis the dearth of data on their levels in samples, it is recommended that their regulation in FPs should focus on: i) controlling the wholesomeness of RMs; and ii) on enforcing strict GMP in using such RMs. Meanwhile relevant agencies should sponsor research into more cost-effective methods.

Herbal Drug Development from Traditional Formulations: Refocusing Pharmaceutics and Posology for Accelerated Validation.

Background: The World Health Organization (WHO) recommended that the toxicity data of a traditional medicine (TM) product that has been in use for 20 years or more without untoward effects should be determined, as the first step in its research and development (R&D). Such data in conjunction with efficacy data would be used to develop an appropriate dosage form of the product. A key objective in researching such a product is to validate the basis of the therapy, including the formula. Such validation, and any attempt to modernize the product, should be guided by an understanding of the traditional know-how. The Nigerian National Institute for Pharmaceutical Research and Development (NIPRD) utilized this approach in developing Niprisan, an antisickling drug, based on a TM product used since antiquity in Yoruba Medicine. Aim: This article aimed to advocate the continuance and improvement of the WHO model of herbal drug research and regulation (HDRR) as the most logical approach for adoption by researchers and regulators. Methodology: NIPRD’s adoption of the WHO model since 1989 was reviewed in parallel with trends in herbal drug research worldwide; and within the contexts of regulatory practices by Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and the European Medicines Evaluation Agency (EMEA), with a view to identifying more effective strategies within the WHO paradigm for HDRR. Conclusion: Drug regulatory agencies (DRAs) like NAFDAC require effective laws, policies and quality management systems (QMS) to execute their mandates effectively. On the other hand, NIPRD’s output depends upon proper actions by a seasoned and responsive DRA. Therefore, noting that NIPRD and NAFDAC were both created by military decrees in 1989 and 1992 respectively, rather than by parliament acts, it is recommended that in addition to instituting more effective laws and policies to regulate NAFDAC, both NIPRD and NAFDAC need to adopt and implement suitable QMS for self-regulation, eg: ISO 9001 for whole organizations; and ISO/IEC 17250 for the laboratories.

Standardization of Andrographis paniculata, Mitracarpus scaber and Nauclea latifolia Herbal Preparations as per European and Nigerian Drug Regulations.

Background: Herbal drug standardization (HDS) is multidisciplinary with botany and chemistry working together to facilitate decisions on production of herbal medicines. The common reasons for HDS are: i) it creates the need for establishing botanical identity; ii) it is necessary for establishing dosage and iii) it facilitates industrial production and good manufacturing practice (GMP). Aims: To outline the strategies being used to standardize Conavir, Niprd-AM1 and Niprifan and to show that HDS is the ideal strategy for herbal drug development (HDD) from traditional medicines (TMs). Methodology: Relevant data on: i) the regulatory requirements of Europe’s Medicines Evaluation Agency (EMEA) and Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and ii) on Andrographis paniculata (AP), Mitracarpus scaber (MS) and Nauclea latifolia (NL) were reviewed. Crude herbal drugs (CHDs) from aerial parts each of AP and MS and from roots of NL and the active crude extracts (ACEs) derived from them were studied using standard botanical, phytochemical and physicochemical techniques with the aim of standardizing them for production. The ACEs from AP (Conavir) and from NL (Niprd-AM1) were dry water extracts. The ACE from MS (Niprifan) was a dry ethylacetate extract. Results: The regulatory provisions of NAFDAC for herbal preparations were broadly similar to those of EMEA but the latter proved more explicit in many respects. Furthermore, the results on the CHDs and ACEs adequately meet the requirements of the two agencies. Conclusions: The results here provided and those reported elsewhere collectively furnish the data needed for drawing-up the registration dossiers of AP/Conavir, NL/Niprd- AM1 and MS/Niprifan as per EMEA and NAFDAC requirements. But for purposes of further work, it is needful for the GC-MS studies to be amplified and combined with others, so as to facilitate identification of suitable markers and pave the way for studies requiring bioassays.

Medical Herbalism and Herbal Clinical Research: A Global Perspective.

This review aims to sensitize researchers, regulators and other stakeholders to the centrality of clinical research to drug development from herbs used in Traditional Medicine (TM). The review uncovered and dwelt on the fact that: While clinical trials of chemical medicines (pharmaceuticals) tend to come late in the drug development chain, the reverse is often the case with herbal medicines (phytomedicines). Once the decision is made to develop a single phytochemical entity (phytopharmaceutical, example: artemisinin) from a plant, the need for such sensitization is particularly desirable, given their huge socioeconomic implications. The review emphasized that drug development from a traditional herb can: i) take the route of standardization of the herb or its extract for immediate use without further chemical manipulations; or ii) proceed along the line of isolation and other manipulations aimed at optimising bioactivity. By the first route, development proceeds directly from confirming that the pharmacological property of the herb tallies with its traditional indication, leading instantly to value addition to traditional knowledge accumulated over years. This is because herbal medicines based on time tested traditions need not undergo phased trials as would a novel pharmaceutical (or an old herb for a new indication), since their long histories often offer evidence of their safety and efficacy. In the second route, clinical studies usually come later in the chain. This is because, unlike the traditional therapeutic, the new phytopharmaceutical, taken out of its natural microenvironment and subjected to various chemical manipulations, including purification, is no longer the equivalent of the ancient remedy with predicable effects. Moreover, in this later case, interest in the new entity (an artificially concentrate isolate) may shift completely from the traditional indication of the herb, hence the need for phased trials of phytopharmaceuticals (or an old herb for a new indication), despite their natural origin.