Magaji Garba

Climbing Black Pepper ( Piper guineense ) Seeds as an Antisickling Remedy

Piper guineense is also known as West African black pepper – just one of a number of other synonyms. It is a spice native to Africa, thriving mainly in the wild. Its culinary and other uses are well documented, but all the initial reports on its use in sickle cell disorder emanated from Nigeria during the late 1990s. In those reports, the seeds were used with parts of other plants to produce the antisickling phytomedicine, Niprisan. Sickle cell crisis involves polymerization of hemoglobin, blockade of capillaries, extreme pain, and widespread necrosis. In this chapter we assemble evidence linking certain constituents of the spice with the various aspects of the crisis, and conclude that those constituents are the likely agents that palliate the crisis. The evidence linking the constituents is as follows. Piperine and capsaicin are vanilloids that interact with receptors/ion channels associated with pain, and they also possess aspirin-like effects, such as allosteric binding to hemoglobin – a property shared with several other by-products of shikimic acid. Cubebin, a tetrahydrodiperonyl-2-furanol, is also a vanilloid containing furan, an allosteric regulator of hemoglobin, and antisickling agent. β-Caryophyllene, also a constituent of the spice, is an agonist of cannabinoid receptor type 2, which functions in endogenous pain control. Remarkably, vanillin, methyl salicylate (an aspirin-like compound) and β-caryophyllene are also present in Eugenia caryophyllata , one of the components of Niprisan.

Phytochemical, Physicochemical and Chromatographic Profiling in Quality Control Systems for Select Herbal Medicines (Conavir and Niprd-AM1)

Background: Conavir, an immunostimulant from aerial parts of Andrographis paniculata (AP) and Niprd-AM1, an antimalarial from roots of Nauclea latifolia (NL), are dry water extracts for capsulation. AP and NL have been in use in Asia and Africa for centuries. Purpose: The study aimed to ascertain the criteria for quality assured production of Conavir and Niprd-AM1. Experimental Details: Procedures of World Health Organization (WHO) were applied to Research Article British Journal of Pharmaceutical Research, 3(1): 13-36, 2013 14 evaluate quality parameters of AP/ Conavir and NL/ Niprd-AM1. Results and Discussion: Conavir is granular, greenish brown, intensely bitter and practically odourless. Tests on AP and Conavir revealed alkaloids, saponins, tannins and terpenoids, but cardiac and cyanogenic glycosides (considered toxic) were not detected. Normal phase TLC of AP and Conavir yielded 5 principal spots each, while the reverse phase TLC yielded 6. HPLC fingerprints of AP, Conavir and a reference standard were reproducible but differed from each other. The GC-MS data of Conavir were consistent with the phytochemical profile of AP. Effect of storage suggested that both AP and Conavir were stable for up to 21 months or more. Niprd-AM1 is granular, yellowish brown and faintly aromatic, with an exciting bitter taste. Both NL and Niprd-AM1 contained alkaloids, saponins, flavonoids and terpenoids, but cardiac and cyanogenic glycosides were not detected. Normal phase TLC of NL yielded 9 principal spots, while Niprd-AM1 yielded 5, but the reverse phase TLC yielded 9 for each. HPLC fingerprints of NL, NiprdAM1 and a reference standard were reproducible but differed from each other. The GCMS data of Niprd-AM1 were consistent with the phytochemical profile of NL. Most of the quality variables of NL and Niprd-AM1 remained unchanged up to the 39th month of storage. Conclusion: The results are consistent with NIPRD’s intention to file for the registration of Conavir and Niprd-AM1 for use in Nigeria.

Herbal Drug Regulation Illustrated with Niprifan® Antifungal Phytomedicine

Sunday J. Ameh1, Obiageri O. Obodozie1, Mujitaba S. Abubakar2, Magaji Garba3 and Karnius S. Gamaniel1 1Department of Medicinal Chemistry and Quality Control, National Institute for Pharmaceutical Research and Development (NIPRD), Garki, Abuja, 2Department of Pharmacognosy and Drug Development, Ahmadu Bello University, Zaria, 3Department of Pharmaceutical and Medicinal Chemistry, Ahmadu Bello University, Zaria, Nigeria

Diversity, utility, analytical methods and use implications of aroma-active compounds from select angiosperm families.

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 Review Article European Journal of Medicinal Plants, 4(9): 1046-1086, 2014 1047 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-a-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 Review Article British Journal of Pharmaceutical Research, 4(12): 1451-1476, 2014 1452 (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.

Application of ISO 9001 Industrial Standard to Herbal Drug Regulation

We noted earlier [1] that 1978 was the turning point in current public perception of tradi‐ tional medicine (TM) following the famous WHO declaration at Alma-Ata. That declaration ushered in a positive attitude that paved the way for the present global popularity of TM, especially herbal medicine. We noted earlier also [2,3] that whereas herbal remedies are called dietary supplements in the US, thereby shifting emphasis away from their medicinal attributes, the Dietary Supplement Health Education Act of 1994 [4], which occasioned the shift, actually helped to promote herbal medicine in the US, albeit indirectly, through the in‐ novative provision it made for user information [5,6]. A similar situation obtained in Eu‐ rope, where the net effect of the laws and rules passed in 2004 on herbal remedies had been to promote their production and use [7, 8]. In terms of trade and economics of herbal drugs, the following fact is notable: Although, Asia contributed only US

Current phytotherapy - A perspective on the science and regulation of herbal medicine

7.3 billion to herbal world trade in 1999 [9], by 2005, a mere 6 years, China’s contribution alone rose to US

Current phytotherapy - an inter-regional perspective on policy, research and development of herbal medicine.

14 billion [10]. This stupendous growth was due to policies and programmes that favoured herbal medicine – the cornerstone of Traditional Chinese Medicine (TCM). Similar situations as in China held sway in Japan, South Korea and the Indian sub-continent, where government policies also favoured herbal medicine. However, in many developing countries like Niger‐ ia, a totally different picture obtained, not because policies were expressly against herbal medicine, but in these countries there had been a lingering absence of proper policies and laws supportive of traditional remedies. Another key fact on the political economy of herbal drugs is that: Although, about 80% of people in developing countries depended on herbs, these countries contributed only 7.2% to herbal drug trade in 1999. By contrast, the devel‐ oped nations, where people relied less on herbs, contributed 55.2%. Asia, less Japan and