What is the best strategy for preclinical testing of botanicals? A critical perspective

Planta Medica

Volumn 78, Issue 8, 2012, Pages 747-754

  Butterweck, Veronika ^a,c   Nahrstedt, Adolf ^b  

^a UNIVERSITY OF FLORIDA HEALTH   (United States)

^b UNIVERSITY OF MÜNSTER   (Germany)

^c UNIVERSITY OF APPLIED SCIENCES AND ARTS NORTHWESTERN SWITZERLAND   (Switzerland)

Author keywords

application; botanicals; dosing; ethnopharmacology; ethnopharmacy; in vitro; in vivo; preclinical testing

Indexed keywords

DIAZEPAM; DIMETHYL SULFOXIDE; DRUG METABOLITE; ENROFLOXACIN; KAEMPFEROL; MYRICETIN; PFAFFIA GLOMERATA EXTRACT; PLANT EXTRACT; QUERCETIN; SECURIDACA LONGEPEDUNCULATA EXTRACT; UNCLASSIFIED DRUG;

ARTIFACT; BIOASSAY; DRUG ABSORPTION; DRUG ACTIVITY; DRUG DETERMINATION; DRUG EFFECT; DRUG FORMULATION; DRUG MEGADOSE; DRUG METABOLISM; DRUG SCREENING; ETHNOPHARMACOLOGY; FRACTIONATION; HUMAN; IC 50; MEDICINAL PLANT; NONHUMAN; REVIEW; SAMPLE SIZE; TRANSLATIONAL RESEARCH;

ANIMALS; BIOLOGICAL ASSAY; DRUG ADMINISTRATION ROUTES; DRUG EVALUATION, PRECLINICAL; HUMANS; PHYTOTHERAPY; PLANT PREPARATIONS; TRANSLATIONAL MEDICAL RESEARCH;

ANIMALIA; MAMMALIA;

EID: 84861454548     PISSN: 00320943     EISSN: 14390221     Source Type: Journal    
DOI: 10.1055/s-0031-1298434     Document Type: Review

References (45)

1. McChesney JD, Venkataraman SK, Henri JT. Plant natural products: back to the future or into extinction? Phytochemistry: 2007; 68 2015 2022 (Pubitemid 47030619)
2. Newman DJ, Cragg GM, Snader KM. Natural products as sources of new drugs over the period 1981-2002. J Nat Prod: 2003; 66 1022 1037 (Pubitemid 36909859)
3. Kohn A. Fortune or failure: missed opportunities and chance discoveries. In: Roberts RM. editor Serendipity: accidental discoveries in science. New York Wiley: 1989; 123 125
4. Taylor L. Pharma R & D spend, NME launches slumped in 2010: study. Available at http://www.pharmatimes.com/article/11-06-28/Pharma-R-D-spend-NME- launches-slumped-in-2010-study.aspx Accessed January 2012
5. Malone M. The pharmacological evaluation of natural products - general and specific approaches to screening ethnopharmaceuticals. J Ethnopharmacol: 1983; 8 127 147 (Pubitemid 14229186)
6. Olejniczak K, Guenzel P, Bass R. Preclinical testing strategies. Drug Inf J: 2001; 35 321 336 (Pubitemid 32524886)
7. Patwardhan B, Mashelkar RA. Traditional medicine-inspired approaches to drug discovery: can Ayurveda show the way forward? Drug Discov Today: 2009; 14 804 811
8. Heinrich M. Ethnopharmacology in the 21st century - grand challenges. Front Pharmacol: 2010; 1 8
9. Gertsch J. How scientific is the science in ethnopharmacology? Historical perspectives and epistemological problems. J Ethnopharmacol: 2009; 122 177 183
10. Kroll DJ, Oberlies NH. The impact of newly proposed dietary supplement manufacturing guidelines on patient safety and clinical trial outcomes. Focus Alternative Compl Ther: 2003; 8 302 306
11. Vogel HG, Vogel W. Drug discovery and evaluation. New York Springer: 2002
12. ICH Harmonized Tripartite Guideline Safety pharmacology studies for human pharmaceuticals S7A. Available at http://www.ich.org/fileadmin/Public-Web-Site/ ICH-Products/Guidelines/Safety/S7A/Step4/S7A-Guideline.pdf Accessed January 2012
13. Adeyemi OO, Akindele AJ, Yemitan OK, Aigbe FR, Fagbo FI. Anticonvulsant, anxiolytic and sedative activities of the aqueous root extract of Securidaca longepedunculata Fresen. J Ethnopharmacol: 2010; 130 191 195
14. Rodriguez-Burford C, Oelschlager DK, Talley LI, Barnes MN, Partridge EE, Grizzle WE. The use of dimethylsulfoxide as a vehicle in cell culture experiments using ovarian carcinoma cell lines. Biotech Histochem: 2003; 78 17 21 (Pubitemid 36416734)
15. Lison D, Huaux F. In vitro studies: Ups and downs of cellular uptake. Nat Nanotechnol: 2011; 6 332 333
16. Subramanian R, Asmawi MZ, Sadikun A. In vitro alpha-glucosidase and alpha-amylase enzyme inhibitory effects of Andrographis paniculata extract and andrographolide. Acta Biochim Pol: 2008; 55 391 398 (Pubitemid 351947554)
17. Matsui T, Kobayashi M, Hayashida S, Matsumoto K. Luteolin, a flavone, does not suppress postprandial glucose absorption through an inhibition of alpha-glucosidase action. Biosci Biotechnol Biochem: 2002; 66 689 692 (Pubitemid 39251036)
18. Palu A, Deng S, West B, Jensen J. Xanthine oxidase inhibiting effects of noni (Morinda citrifolia) fruit juice. Phytother Res: 2009; 23 1790 1791
19. Verpoorte R. Setting standards! J Ethnopharmacol: 2006; 106 289
20. Cos P, Vlietinck AJ, Berghe DV, Maes L. Anti-infective potential of natural products: how to develop a stronger in vitro proof-of-concept J Ethnopharmacol: 2006; 106 290 302 (Pubitemid 43949328)
21. Sarawek S, Feistel B, Pischel I, Butterweck V. Flavonoids of Cynara scolymus possess potent xanthinoxidase inhibitory activity in vitro but are devoid of hypouricemic effects in rats after oral application. Planta Med: 2008; 74 221 227 (Pubitemid 351449942)
22. Sarawek S, Derendorf H, Butterweck V. Pharmacokinetics of luteolin and metabolites in rats. Nat Prod Commun: 2008; 3 2029 2036
23. Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J: 2008; 22 659 661 (Pubitemid 351348146)
24. Baur JA, Pearson KJ, Price NL, Jamieson HA, Lerin C, Kalra A, Prabhu VV, Allard JS, Lopez-Lluch G, Lewis K, Pistell PJ, Poosala S, Becker KG, Boss O, Gwinn D, Wang M, Ramaswamy S, Fishbein KW, Spencer RG, Lakatta EG, Le Couteur D, Shaw RJ, Navas P, Puigserver P, Ingram DK, de Cabo R, Sinclair DA. Resveratrol improves health and survival of mice on a high-calorie diet. Nature: 2006; 444 337 342 (Pubitemid 44764104)
25. Center for Drug Evaluation and Research Center for Biological and Research Estimating the safe and starting dose in clinical trials for therapeutics in adult healthy volunteers. Rockville, Maryland, USA US Food and Drug Administration: 2002
26. Nebendahl K, Hauff P. Drug administration. In: Kiessling F, Pichler BJ, Hauff P. editors Small animal imaging. Heidelberg Springer: 2011; 93 119
27. Svendsen O. Ethics and animal welfare related to in vivo pharmacology and toxicology in laboratory animals. Basic Clin Pharmacol Toxicol: 2005; 97 197 199
28. Claassen V. Neglected factors in pharmacology and neuroscience research. In: Huston JP. editor Techniques in the behavioural and neural sciences. Amsterdam Elsevier: 1994; 46 58
29. Gotloib L, Wajsbrot V, Shostak A. A short review of experimental peritoneal sclerosis: from mice to men. Int J Artif Organs: 2005; 28 97 104 (Pubitemid 40485207)
30. Ryabinin AE, Wang YM, Finn DA. Different levels of Fos immunoreactivity after repeated handling and injection stress in two inbred strains of mice. Pharmacol Biochem Behav: 1999; 63 143 151 (Pubitemid 29206573)
31. Wright DM, Lincoln DW. Stress-induced analgesia evoked by intraperitoneal injection of hypertonic saline: evidence for its occurrence in vasopressin deficient rats. Physiol Behav: 1985; 34 691 695 (Pubitemid 15006673)
32. de-Paris F, Neves G, Salgueiro JB, Quevedo J, Izquierdo I, Rates SM. Psychopharmacological screening of Pfaffia glomerata Spreng. (Amaranthaceae) in rodents. J Ethnopharmacol: 2000; 73 261 269
33. Akao T, Yoshino T, Kobashi K, Hattori M. Evaluation of salicin as an antipyretic prodrug that does not cause gastric injury. Planta Med: 2002; 68 714 718 (Pubitemid 35013383)
34. Atkinson C, Berman S, Humbert O, Lampe JW. In vitro incubation of human feces with daidzein and antibiotics suggests interindividual differences in the bacteria responsible for equol production. J Nutr: 2004; 134 596 599 (Pubitemid 38298502)
35. Mullen W, Rouanet JM, Auger C, Teissedre PL, Caldwell ST, Hartley RC, Lean ME, Edwards CA, Crozier A. Bioavailability of [2-(14)C]quercetin-4- glucoside in rats. J Agric Food Chem: 2008; 56 12127 12137
36. Aura AM, OLeary KA, Williamson G, Ojala M, Bailey M, Puupponen-Pimia R, Nuutila AM, Oksman-Caldentey KM, Poutanen K. Quercetin derivatives are deconjugated and converted to hydroxyphenylacetic acids but not methylated by human fecal flora in vitro. J Agric Food Chem: 2002; 50 1725 1730 (Pubitemid 34233254)
37. Blaut M, Schoefer L, Braune A. Transformation of flavonoids by intestinal microorganisms. Int J Vitam Nutr Res: 2003; 73 79 87 (Pubitemid 36427774)
38. Griffiths LA, Smith GE. Metabolism of myricetin and related compounds in the rat. Metabolite formation in vivo and by the intestinal microflora in vitro. Biochem J: 1972; 130 141 151
39. Keppler K, Hein EM, Humpf HU. Metabolism of quercetin and rutin by the pig caecal microflora prepared by freeze-preservation. Mol Nutr Food Res: 2006; 50 686 695 (Pubitemid 44342465)
40. Labib S, Hummel S, Richling E, Humpf HU, Schreier P. Use of the pig caecum model to mimic the human intestinal metabolism of hispidulin and related compounds. Mol Nutr Food Res: 2006; 50 78 86 (Pubitemid 43155098)
41. Scalbert A, Morand C, Manach C, Remesy C. Absorption and metabolism of polyphenols in the gut and impact on health. Biomed Pharmacother: 2002; 56 276 282 (Pubitemid 35245310)
42. Vissiennon C, Nieber K, Kelber O, Butterweck V. Route of administration determines the anxiolytic activity of the flavonols kaempferol, quercetin and myricetin - are they prodrugs? J Nutr Biochem in press
43. Butterweck V, Lieflander-Wulf U, Winterhoff H, Nahrstedt A. Plasma levels of hypericin in presence of procyanidin B2 and hyperoside: a pharmacokinetic study in rats. Planta Med: 2003; 69 189 192 (Pubitemid 36470120)
44. Nahrstedt A, Butterweck V. Lessons learned from herbal medicinal products: the example of St. Johns Wort. J Nat Prod: 2010; 73 1015 1021
45. Gertsch J. Botanical drugs, synergy, and network pharmacology: forth and back to intelligent mixtures. Planta Med: 2011; 77 1086 1098