An in-vivo herb-drug interaction study of Tinospora cordifolia extract on the pharmacokinetics of gliclazide in normal Wistar rats

Yıl 2022, , 31 - 36, 28.04.2022

Asha Thomas , Seema Kamble Sohan Chitlange Archana Thıkekar

https://doi.org/10.26650/IstanbulJPharm.2022.959603

Öz

Background and Aims: Tinospora cordifolia (Willd.) Miers (TC), from the Menispermaceae family, is a well-known traditional herb used to treat diabetes mellitus and a variety of other ailments, according to traditional Indian literature. Herbal treat- ments are commonly used as alternatives to medicines. Anti-diabetic herbal medicines containing TC are available in the market. TC has been identified as a powerful CYP2C9 inhibitor, boosting the risk of herb-drug interactions (HDI) when used with medications metabolized via the CYP pathway. The present study evaluated the pharmacokinetic HDI of TC extract with Gliclazide (GL) after oral co-administration in Wistar rats using in vivo pharmacokinetic studies.
Methods: A simple, sensitive & accurate RP-HPLC/PDA method was developed and validated. Chromatographic separations were performed on a C18 analytical column with a mobile phase of acetonitrile and 40 mM ammonium acetate buffer (55:45 v/v) pH 3.0 and flow rate gradient programming. The drug concentrations in plasma were measured using the RP-HPLC method after oral co-administration of TC extract (100 mg/kg) with GL (8.3 mg/kg) in Wistar rats.
Results: The pharmacokinetic (PK) interaction studies showed that the bioavailability of GL had significantly increased, with a significant influence on Cmax, AUC0-48, and suppression of volume of distribution (Vd), with no change in Tmax.
Conclusion: The results obtained from this in vivo study proposed that there is a potentially significant PK HDI when GL and TC extract are administered together. This knowledge of potential HDI could be beneficial to healthcare providers and diabetic patients on GL medication. Further research is needed to anticipate this pharmacokinetics HDI of GL in humans.

Anahtar Kelimeler

Gliclazide, Tinospora cordifolia, Herb-drug interaction, RP-HPLC, Pharmacokinetic

Destekleyen Kurum

Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune 411 018 (MS), India

Kaynakça

• Adhikari, L., Mishra, U. S., & Murthy, P. N. (2014). RP-HPLC deter- mination of gliclazide in rat plasma and its application in phar- macokinetic studies. International Journal of PharmTech Research, 6(2), 692–700.
• Bahadur, S., Mukherjee, P., Milan Ahmmed, S., Kar, A., Harwansh, R., &Pandit, S. (2016). Metabolism-mediated interaction potential of standardized extract of Tinospora cordifolia through rat and human liver microsomes. Indian Journal of Pharmacology, 48(5), 576–581. https://doi.org/10.4103/0253-7613.190758
• Brantley, S. J., Argikar, A. A., Lin, Y. S., Nagar, S., & Paine, M. F. (2014). Herb-drug interactions: Challenges and opportunities for im- proved predictions. Drug Metabolism and Disposition, 42(3), 301– 317. https://doi.org/10.1124/dmd.113.055236
• Chatterjee, P., & Franklin, M. R. (2003). Human cytochrome p450 inhibition and metabolic-intermediate complex formation by goldenseal extract and its methylenedioxyphenyl components. Drug Metabolism and Disposition: The Biological Fate of Chemicals, 31(11), 1391–1397. https://doi.org/10.1124/dmd.31.11.1391
• Choudhary, N., Siddiqui, M. B., & Khatoon, S. (2014). Pharmacog- nostic evaluation of Tinospora cordifolia (Willd.) Miers and iden- tification of biomarkers. Indian Journal of Traditional Knowledge, 13(3), 543–550.
• Fugh-Berman, A., & Ernst, E. (2001). Herb-drug interactions: re- view and assessment of report reliability. British Journal of Clinical Pharmacology, 52(5), 587–595. https://doi.org/10.1046/j.0306- 5251.2001.01469.x
• Hu, Z., Yang, X., Ho, P. C. L., Chan, S. Y., Heng, P. W. S., Chan, E., Duan, W., Koh, H. L., & Zhou, S. (2005). Herb-drug interac- tions: a literature review. Drugs, 65(9), 1239–1282. https://doi. org/10.2165/00003495-200565090-00005
• Kuo, C.-Y., & Wu, S.-M. (2005). High-performance liquid chroma- tography with electrochemical detection for analysis of gliclazide in plasma. Journal of Chromatography. A, 1088(1–2), 131—135. https://doi.org/10.1016/j.chroma.2004.12.097
• Meshram, A., Bhagyawant, S., Gautam, S., & Srivastava, N. (2013). Potential role of Tinosporacordifolia in pharmaceuticals. World Journal of Pharmaceutical Sciences, 2, 4615–4625.
• Posadzki, P., Watson, L., & Ernst, E. (2013). Herb-drug interac- tions: an overview of systematic reviews. British Journal of Clinical Pharmacology, 75(3), 603–618. https://doi.org/10.1111/j.1365- 2125.2012.04350.x
• Prabhakar, P. K., &Doble, M. (2008). A target based thera- peutic approach towards diabetes mellitus using medicinal plants. Current Diabetes Reviews, 4(4), 291–308. https://doi. org/10.2174/157339908786241124
• Sahu, R., Ahmed, T., Sangana, R., Punde, R., &Subudhi, B. B. (2018). Effect of Tinospora cordifolia aqua-alcoholic extract on phar- macokinetic of Glibenclamide in rats: An herb-drug interaction study. Journal of Pharmaceutical and Biomedical Analysis, 151, 310–316. https://doi.org/10.1016/j.jpba.2018.01.010
• Sarkar, A., Tiwari, A., Bhasin, P. S., & Mitra, M. (2011). Pharmacologi- cal and pharmaceutical profile of gliclazide: A review. Journal of Applied Pharmaceutical Science, 1(9), 11–19.
• Shaikh, A. S., Thomas, A. B., & Chitlange, S. S. (2020). Herb–drug interaction studies of herbs used in treatment of cardiovascular disorders—A narrative review of preclinical and clinical studies. Phytotherapy Research, 34(5), 1008–1026.https://doi.org/10.1002/ ptr.6585
• Singh, R. P., Banerjee, S., Kumar, P. V. S., Raveesha, K. A., & Rao, A.R. (2006). Tinospora cordifolia induces enzymes of carcinogen/ drug metabolism and antioxidant system, and inhibits lipid per- oxidation in mice. Phytomedicine : International Journal of Phy- totherapy and Phytopharmacology, 13(1–2), 74–84. https://doi. org/10.1016/j.phymed.2004.02.013
• Thikekar, A. K., Thomas, A. B., & Chitlange, S. S. (2021). Herb-drug interactions in diabetes mellitus: A review based on pre-clinical and clinical data. Phytotherapy Research, 35(9): 4763-4781. https:// doi.org/10.1002/ptr.7108
• Thomas, A. B., Shaikh, A. S., Raje, A., Lokhande, K. B., Swamy, K. V., Nagore, D. H., & Doke, R. (2020). Herb drug interaction of Tinos- pora cordifolia (Willd.) Miers extract and Glimepiride: In vivo and in silico studies. Medicinal Plants-International Journal of Phytomedi- cines and Related Industries, 12(4), 555-567.
• Tsai, H.-H., Lin, H.-W., Simon Pickard, A., Tsai, H.-Y., &Mahady, G. B. (2012). Evaluation of documented drug interactions and con- traindications associated with herbs and dietary supplements: a systematic literature review. International Journal of Clinical Practice, 66(11), 1056–1078. https://doi.org/10.1111/j.1742- 1241.2012.03008.x
• Wills, R. B., Bone, K., & Morgan, M. (2000). Herbal prod- ucts: active constituents, modes of action and qual- ity control. Nutrition Research Reviews, 13(1), 47–77. https://doi. org/10.1079/095442200108729007
• Xu, H., Williams, K. M., Liauw, W. S., Murray, M., Day, R. O., & McLach- lan, A. J. (2008). Effects of St John’s wort and CYP2C9 genotype on the pharmacokinetics and pharmacodynamics of gliclazide. British Journal of Pharmacology, 153(7), 1579–1586. https://doi. org/10.1038/sj.bjp.0707685
• Yao, Y., Han, W.-W., Zhou, Y.-H., Li, Z.-S., Li, Q., Chen, X.-Y., &Zhong, D.-F. (2009). The metabolism of CYP2C9 and CYP2C19 for glicla- zide by homology modeling and docking study. European Journal of Medicinal Chemistry, 44(2), 854–861. https://doi.org/10.1016/j.