69
Views
0
CrossRef citations to date
0
Altmetric
Research Articles

In-silico, in-vitro and ex-vivo evidence of combining silymarin phytopharmaceutical with piperine, and fulvic acid for enhancing its solubility and permeability

, , , &
Pages 595-610 | Received 09 Feb 2023, Accepted 13 Jun 2023, Published online: 24 Jun 2023

References

  • Abend A, Curran D, Kuiper J, Lu X, Li H, Hermans A, Kotwal P, Diaz DA, Cohen MJ, Zhang L. 2019. Dissolution testing in drug product development: workshop summary report. AAPS J. 21(2):21.
  • Ahamad T. 2021. Workflow docking with autodock 4: a beginner’s guide.
  • Alam MA, Al-Jenoobi FI, Al-Mohizea AM. 2012. Everted gut sac model as a tool in pharmaceutical research: limitations and applications. J Pharm Pharmacol. 64(3):326–336. doi: 10.1111/j.2042-7158.2011.01391.x.
  • Al-Lazikani B. 2004. Rule of five (Lipinski Rule of Five).
  • Aziz DM, Hama JR, Alam SM. 2015. Synthesising a novel derivatives of piperine from black pepper (Piper nigrum L.). Food Measure. 9(3):324–331. doi: 10.1007/s11694-015-9239-2.
  • Bano G, Raina RK, Zutshi U, Bedi KL, Johri RK, Sharma SC. 1991. Effect of piperine on bioavailability and pharmacokinetics of propranolol and theophylline in healthy volunteers. Eur J Clin Pharmacol. 41(6):615–617. doi: 10.1007/BF00314996.
  • Chen L, Deng H, Cui H, Fang J, Zuo Z, Deng J, Li Y, Wang X, Zhao L. 2018. Inflammatory responses and inflammation-associated diseases in organs. Oncotarget. 9(6):7204–7218. doi: 10.18632/oncotarget.23208.
  • Daina A, Michielin O, Zoete V. 2017. SwissADME: a free web tool to evaluate pharmacokinetics, drug-likeness and medicinal chemistry friendliness of small molecules. Sci Rep. 7:42717. doi: 10.1038/srep42717.
  • Dickinson PA, Lee WW, Stott PW, Townsend AI, Smart JP, Ghahramani P, Hammett T, Billett L, Behn S, Gibb RC, et al. 2008. Clinical relevance of dissolution testing in quality by design. Aaps J. 10(2):380–390. doi: 10.1208/s12248-008-9034-7.
  • Dressman JB, Krämer J. 2005. Pharmaceutical dissolution testing. Raton, FL: Taylor & Francis Boca.
  • Eedara BB, Veerareddy PR, Jukanti R, Bandari S. 2014. Improved oral bioavailability of fexofenadine hydrochloride using lipid surfactants: ex vivo, in situ and in vivo studies. Drug Dev Ind Pharm. 40(8):1030–1043. doi: 10.3109/03639045.2013.801984.
  • El-Kattan AF, Varma MV, Steyn SJ, Scott DO, Maurer TS, Bergman A. 2016. Projecting ADME Behavior and Drug-Drug Interactions in Early Discovery and Development: application of the Extended Clearance Classification System. Pharm Res. 33(12):3021–3030. eng. doi: 10.1007/s11095-016-2024-z.
  • Elmezayen A. 2020. AutoDock tutorial.
  • General Chapter. 2019. US pharmacopoeia.
  • Gillessen A, Schmidt HH. 2020. Silymarin as supportive treatment in liver diseases: a narrative review. Adv Ther. 37(4):1279–1301. eng. doi: 10.1007/s12325-020-01251-y.
  • Gnananath K, Nataraj KS, Rao BG, Kumar KP, Mahnashi MH, Anwer MK, Umar A, Iqbal Z, Mirza MA. 2020. Exploration of fulvic acid as a functional excipient in line with the regulatory requirement. Environ Res. 187:109642. doi: 10.1016/j.envres.2020.109642.
  • Gupta SK, Bansal P, Bhardwaj RK, Velpandian T. 2000. Comparative anti-nociceptive, anti-inflammatory and toxicity profile of nimesulide vs nimesulide and piperine combination. Pharmacol Res. 41(6):657–662. doi: 10.1006/phrs.1999.0640.
  • Javed S, Ahsan W, Kohli K. 2016. The concept of bioenhancers in bioavailability enhancement of drugs–a patent review. J Sci Lett. 1:143–165.
  • Javed S ,Kohli K ,Ahsan W. 2016. Solubility and dissolution enhancement of silymarin with fulvic acid carrier. Inter J Drug Develop Res. 8(1):9–14.
  • Jin MJ, Han HK. 2010. Effect of piperine, a major component of black pepper, on the intestinal absorption of fexofenadine and its implication on food-drug interaction. J Food Sci. 75(3):H93–96. eng. doi: 10.1111/j.1750-3841.2010.01542.x.
  • Johnson JJ, Nihal M, Siddiqui IA, Scarlett CO, Bailey HH, Mukhtar H, Ahmad N. 2011. Enhancing the bioavailability of resveratrol by combining it with piperine. Mol Nutr Food Res. 55(8):1169–1176. eng. doi: 10.1002/mnfr.201100117.
  • Kalopitas G, Antza C, Doundoulakis I, Siargkas A, Kouroumalis E, Germanidis G, Samara M, Chourdakis M. 2021. Impact of Silymarin in individuals with nonalcoholic fatty liver disease: a systematic review and meta-analysis. Nutrition. 83:111092. doi: 10.1016/j.nut.2020.111092.
  • Kasibhatta R, Naidu MUR. 2007. Influence of piperine on the pharmacokinetics of nevirapine under fasting conditions. Drugs R D. 8(6):383–391. doi: 10.2165/00126839-200708060-00006.
  • Khan R, Jain P, Zakir F, Aqil M, Alshehri S, Mirza MA, Iqbal Z. 2022. Quality and in vivo assessment of a fulvic acid complex: a validation study. Sci Pharm. 90(2):33. doi: 10.3390/scipharm90020033.
  • Lambert JD, Hong J, Kim DH, Mishin VM, Yang CS. 2004. Piperine enhances the bioavailability of the tea polyphenol (−)-epigallocatechin-3-gallate in mice. J Nutr. 134(8):1948–1952. doi: 10.1093/jn/134.8.1948.
  • Mayer K, Myers R, Lee S. 2005. Silymarin treatment of viral hepatitis: a systematic review. J Viral Hepat. 12(6):559–567. doi: 10.1111/j.1365-2893.2005.00636.x.
  • Mirza MA, Ahmad N, Agarwal SP, Mahmood D, Anwer MK, Iqbal Z. 2011. Comparative evaluation of humic substances in oral drug delivery. Results Pharma Sci. 1(1):16–26. doi: 10.1016/j.rinphs.2011.06.001.
  • Pattanaik S, Hota D, Prabhakar S, Kharbanda P, Pandhi P. 2009. Pharmacokinetic interaction of single dose of piperine with steady-state carbamazepine in epilepsy patients. Phytother Res. 23(9):1281–1286. eng. doi: 10.1002/ptr.2676.
  • Ralli T, Kalaiselvan V, Tiwari R, Shukla S, Kohli K. 2021. Clinical and Regulatory Status of Silymarin. Appl Drug Res Clinical Trials Regul Affairs. 8(2):104–111.
  • Ralli T, Neupane YR, Saifi Z, Kohli K. 2021. Gut microbiota as an emerging therapeutic avenue for the treatment of nonalcoholic fatty liver disease. Curr Pharm Des. 27(46):4677–4685. doi: 10.2174/1389201022666210625141526.
  • Ralli T, Saifi Z, Tyagi N, Vidyadhari A, Aeri V, Kohli K. 2022. Deciphering the role of gut metabolites in non-alcoholic fatty liver disease. Crit Rev Microbiol. 1-9.doi: 10.1080/1040841X.2022.2142091.
  • Ralli T, Tripathi T, Kalaiselvan V, Tiwari R, Aeri V, Kohli K. 2023. Silymarin as a Phyto-pharmaceutical: isolation, simultaneous quantification of four biomarkers and in-silico anti-inflammatory activity. Chin J Anal Chem. 51(3):100174. doi: 10.1016/j.cjac.2022.100174.
  • Saifi Z, Rizwanullah M, Mir SR, Amin S. 2020. Bilosomes nanocarriers for improved oral bioavailability of acyclovir: a complete characterization through in vitro, ex-vivo and in vivo assessment. J Drug Delivery Sci Technol. 57:101634. doi: 10.1016/j.jddst.2020.101634.
  • Sander T. 2001. OSIRIS property explorer. Organic Chemistry Portal. https://wwworganic-chemistryorg/prog/peo/
  • Silymarin. 2019. Indian pharmacopoeia.
  • Singh A, Deep A. 2011. Piperine: a bioenhancer. Intern J Pharm Res Technol. 1(1):01–05.
  • Soleimani V, Delghandi PS, Moallem SA, Karimi G. 2019. Safety and toxicity of silymarin, the major constituent of milk thistle extract: an updated review. Phytother Res. 33(6):1627–1638. doi: 10.1002/ptr.6361.
  • Vilar-Gomez E, Vuppalanchi R, Gawrieh S, Ghabril M, Saxena R, Cummings OW, Chalasani N. 2018. Vitamin E improves transplant-free survival and hepatic decompensation among patients with NASH and advanced fibrosis. Hepatology. 71(2):495–509.
  • Xu Y, Guo W, Zhang C, Chen F, Tan HY, Li S, Wang N, Feng Y. 2020. Herbal medicine in the treatment of non-alcoholic fatty liver diseases-efficacy, action mechanism, and clinical application. Front Pharmacol. 11:601.
  • Younossi ZM, Loomba R, Rinella ME, Bugianesi E, Marchesini G, Neuschwander-Tetri BA, Serfaty L, Negro F, Caldwell SH, Ratziu V, et al. 2018. Current and future therapeutic regimens for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Hepatology. 68(1):361–371. doi: 10.1002/hep.29724.
  • Zhang L, Yao Z, Ji G. 2018. Herbal extracts and natural products in alleviating non-alcoholic fatty liver disease via activating autophagy. Front Pharmacol. 9:1459.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.