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Current Drug Research Reviews

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ISSN (Print): 2589-9775
ISSN (Online): 2589-9783

Research Article

Therapeutic Potential of Antileukotriene Drug-Camellia sinensis Extract Co-Formulation on Histamine Induced Asthma in Guinea Pigs

Author(s): Neelam Singh*, Giriraj T. Kulkarni and Yatendra Kumar

Volume 13, Issue 1, 2021

Published on: 12 August, 2020

Page: [59 - 72] Pages: 14

DOI: 10.2174/2589977512666200812151620

Price: $65

Abstract

Background/Objective: To study the therapeutic potential of Antileukotriene drug- Camellia sinensis extract co-formulation on histamine induced asthma in guinea pigs.

Methods: SRSD of Montelukast sodium was prepared by the solvent evaporation method. Lyophilized aqueous extract of Camellia sinensis leaves and SRSD mixture was filled in capsule and the capsule shell was coated to achieve initial release lag time. In vitro and pharmacokinetic study of capsules was performed and compared with commercial tablets. A further role of green tea, as an antioxidant adjunct for asthma management, has been analyzed by lung histology, mast cell count and oxidative stress assay in the serum of control and experimental animals.

Results: The drug release from the commercial tablet was immediate and rapid, but capsule has shown an initial 3.5 hr lag time followed by sustained action up to 8 hr. Pharmacokinetic results show that studied formulations are bioequivalent with respect to Cmax and AUC, while rest parameters showed asignificant difference. Mast cells count in lung tissue were increased (p<0.001) in the experimental group along with glycoprotein deposition in asthmatic bronchioles. Levels of SOD and GPX were decreased (p<0.05) while CAT was increased (p<0.04) in the asthma group in comparison to control.

Conclusion: In the experimental animal model, co-formulation was effective in modulating allergic inflammation and contributing to better control of the inflammatory response. Our findings suggest that Camellia sinensis leaves extract may be used as an adjunct for future improvements in asthma treatment and prevention.

Keywords: Adjunct, asthma, oxidative stress, green tea, sustained release solid dispersion, healing.

Graphical Abstract
[1]
Amaral-Machado L, Oliveira WN, Moreira-Oliveira SS, et al. Use of natural products in asthma treatment. Evid Based Complement Alternat Med 2020; 2020: 1021258.
[http://dx.doi.org/10.1155/2020/1021258] [PMID: 32104188]
[2]
Litinski M, Scheer FA, Shea SA. Influence of the circadian system on disease severity. Sleep Med Clin 2009; 4(2): 143-63.
[http://dx.doi.org/10.1016/j.jsmc.2009.02.005] [PMID: 20161149]
[3]
Reddy PH. Mitochondrial dysfunction and oxidative stress in asthma: Implications for mitochondria-targeted antioxidant therapeutics. Pharmaceuticals (Basel) 2011; 4(3): 429-56.
[http://dx.doi.org/10.3390/ph4030429] [PMID: 21461182]
[4]
Diamant Z, Mantzouranis E, Bjermer L. Montelukast in the treatment of asthma and beyond. Expert Rev Clin Immunol 2009; 5(6): 639-58.
[http://dx.doi.org/10.1586/eci.09.62] [PMID: 20477688]
[5]
Sahiner UM, Birben E, Erzurum S, Sackesen C, Kalayci O. Oxidative stress in asthma. World Allergy Organ J 2011; 4(10): 151-8.
[http://dx.doi.org/10.1097/WOX.0b013e318232389e] [PMID: 23268432]
[6]
Zhu LY, Ni ZH, Luo XM, Wang XB. Advance of antioxidants in asthma treatment. World J Respirol 2017; 7: 17-28.
[http://dx.doi.org/10.5320/wjr.v7.i1.17]
[7]
Wood LG, Garg ML, Smart JM, Scott HA, Barker D, Gibson PG. Manipulating antioxidant intake in asthma: A randomized controlled trial. Am J Clin Nutr 2012; 96(3): 534-43.
[http://dx.doi.org/10.3945/ajcn.111.032623] [PMID: 22854412]
[8]
Castro SM, Guerrero-Plata A, Suarez-Real G, et al. Antioxidant treatment ameliorates respiratory syncytial virus-induced disease and lung inflammation. Am J Respir Crit Care Med 2006; 174(12): 1361-9.
[http://dx.doi.org/10.1164/rccm.200603-319OC] [PMID: 17008643]
[9]
Mabalirajan U, Aich J, Leishangthem GD, Sharma SK, Dinda AK, Ghosh B. Effects of vitamin E on mitochondrial dysfunction and asthma features in an experimental allergic murine model. J Appl Physiol 2009; 107(4): 1285-92.
[http://dx.doi.org/10.1152/japplphysiol.00459.2009] [PMID: 19628725]
[10]
Dilek F, Ozkaya E, Kocyigit A, et al. Effect of montelukast monotherapy on oxidative stress parameters and DNA damage in children with asthma. Int Arch Allergy Immunol 2015; 167(2): 119-26.
[http://dx.doi.org/10.1159/000436967] [PMID: 26303984]
[11]
Hamer M. The beneficial effects of tea on immune function and inflammation: A review of evidence from in vitro, animal, and human research. Nutr Res 2007; 27: 373-9.
[http://dx.doi.org/10.1016/j.nutres.2007.05.008]
[12]
Lambert JD, Elias RJ. The antioxidant and pro-oxidant activities of green tea polyphenols: A role in cancer prevention. Arch Biochem Biophys 2010; 501(1): 65-72.
[http://dx.doi.org/10.1016/j.abb.2010.06.013] [PMID: 20558130]
[13]
Farooq S, Sehgal A. Antioxidant activity of different forms of green tea: Loose leaf, bagged and matcha. Curr Res Nutr Food Sci 2018; 6(1)
[http://dx.doi.org/10.12944/CRNFSJ.6.1.04]
[14]
Kurita T, Miyagishima A, Nozawa Y, Sadzuka Y, Sonobe T. A dosage design of mitomycin C tablets containing finely powdered green tea. Int J Pharm 2004; 275(1-2): 279-83.
[http://dx.doi.org/10.1016/j.ijpharm.2004.01.037] [PMID: 15081158]
[15]
Suganuma M, Saha A, Fujiki H. New cancer treatment strategy using combination of green tea catechins and anticancer drugs. Cancer Sci 2011; 102(2): 317-23.
[http://dx.doi.org/10.1111/j.1349-7006.2010.01805.x] [PMID: 21199169]
[16]
Fazly Bazzaz BS, Sarabandi S, Khameneh B, Hosseinzadeh H. Effect of catechins, green tea extract and methylxanthines in combination with gentamicin against Staphylococcus aureus and Pseudomonas aeruginosa: - combination therapy against resistant bacteria. J Pharmacopuncture 2016; 19(4): 312-8.
[http://dx.doi.org/10.3831/KPI.2016.19.032] [PMID: 28097041]
[17]
Cao J, Han J, Xiao H, Qiao J, Han M. Effect of tea polyphenol compounds on anticancer drugs in terms of anti-tumor activity, toxicology, and pharmacokinetics. Nutrients 2016; 8(12): 762-70.
[http://dx.doi.org/10.3390/nu8120762] [PMID: 27983622]
[18]
Shen JZ, Ng TLJ, Ho WS. Therapeutic potential of phytochemicals in combination with drugs for cardiovascular disorders. Curr Pharm Des 2017; 23(6): 961-6.
[http://dx.doi.org/10.2174/1381612822666161006145547] [PMID: 27719646]
[19]
Gupta KR, Pounikar AR, Umekar MJ. Drug excipient compatibility testing protocols and charaterization: A review. Asian J Chem Sci 2019; 6(3): 1-22.
[http://dx.doi.org/10.9734/ajocs/2019/v6i319000]
[20]
Sateesha S, Rajamma A, Shekar H, Divakar G. Formulation development and rheological studies of palatable cefetamet pivoxil hydrochloride dry powder suspension. Daru 2011; 19(2): 118-25.
[PMID: 22615648]
[21]
Mahdi HJ. Eudragit L-100 for enteric coating of hard gelatin capsules formulation and evaluation. Issues Biol Sci Pharm Res 2015; 3(2): 14-20.
[22]
Ranjan OP, Nayak UY, Reddy MS, Dengale SJ, Musmade PB, Udupa N. Development and validation of RP-HPLC method with ultraviolet detection for estimation of montelukast in rabbit plasma: Application to preclinical pharmacokinetics. J Young Pharm 2013; 5(4): 133-8.
[http://dx.doi.org/10.1016/j.jyp.2013.10.006] [PMID: 24563591]
[23]
Miller DS, Parsons AM, Bresland J, et al. A simple and inexpensive enteric-coated capsule for delivery of acid-labile macromolecules to the small intestine. J Zhejiang Univ Sci B 2015; 16(7): 586-92.
[http://dx.doi.org/10.1631/jzus.B1400290] [PMID: 26160716]
[24]
Neha SL, Singh N, Yasir M. Sustained release solid dispersion of Metoclopramide HCL: Formulation, evaluation and pharmacokinetic studies. J Appl Pharm Sci 2015; 5(3): 55-65.
[http://dx.doi.org/10.7324/JAPS.2015.50310]
[25]
Lee YS, Song JG, Lee SH, Han HK. Sustained-release solid dispersion of pelubiprofen using the blended mixture of aminoclay and pH independent polymers: Preparation and in vitro/in vivo characterization. Drug Deliv 2017; 24(1): 1731-9.
[http://dx.doi.org/10.1080/10717544.2017.1399304] [PMID: 29124978]
[26]
Banerjee S, Chatterjee J. Efficient extraction strategies of tea (Camellia sinensis) biomolecules. J Food Sci Technol 2015; 52(6): 3158-68.
[PMID: 26028699]
[27]
Sharma NK, Ahirwar D, Jhade D, Jain VK. In-vitro anti-obesity assay of alcoholic and aqueous extracts of Camellia sinensis leaves. Int J Pharm Sci Res 2012; 3: 1863-6.
[28]
Trease GE, Evans WC. Introduction and general methods in Pharmacognosy. 14th ed. London: Alden press 2002.
[29]
Wanyika HN, Gatebe EG, Gitu LM, Ngumba EK, Maritim CW. Determination of caffeine content of tea and instant coffee brands found in the Kenyan market. Afr J Food Sci 2010; 4(6): 353-8.
[30]
Fernando CD, Soysa P. Simple isocratic method for simultaneous determination of caffeine and catechins in tea products by HPLC. Springerplus 2016; 5(1): 970-5.
[http://dx.doi.org/10.1186/s40064-016-2672-9] [PMID: 27429880]
[31]
He Q, Yao K, Jia D, Fan H, Liao X, Shi B. Determination of total catechins in tea extracts by HPLC and spectrophotometry. Nat Prod Res 2009; 23(1): 93-100.
[http://dx.doi.org/10.1080/14786410801886682] [PMID: 19140075]
[32]
Lan K, Xie G, Jia W. Towards polypharmacokinetics: Pharmacokinetics of multicomponent drugs and herbal medicines using a metabolomics approach. Evid Based Complement Alternat Med 2013; 2013: 819147.
[http://dx.doi.org/10.1155/2013/819147] [PMID: 23573155]
[33]
Singh N, Kulkarni GT, Kumar Y. Pharmacokinetic comparison of montelukast sodium formulations after a single oral dose in healthy guinea pigs. Asian J Pharm Clin Res 2019; 12(2): 165-9.
[http://dx.doi.org/10.22159/ajpcr.2019.v12i2.29279]
[34]
Patil-Gadhe A, Kyadarkunte A, Patole M, Pokharkar V. Montelukast-loaded nanostructured lipid carriers: part II pulmonary drug delivery and in vitro-in vivo aerosol performance. Eur J Pharm Biopharm 2014; 88(1): 169-77.
[http://dx.doi.org/10.1016/j.ejpb.2014.07.007] [PMID: 25078860]
[35]
Velez de Mendizabal N, Jimenez-Mendez R, Cooke E, et al. A compartmental analysis for morphine and its metabolites in young children after a single oral dose. Clin Pharmacokinet 2015; 54(10): 1083-90.
[http://dx.doi.org/10.1007/s40262-015-0256-4] [PMID: 25773480]
[36]
Shafaati A, Zarghi A, Foroutan SM, Khoddam A, Madadian B. Rapid and sensitive determination of Montelukast in human plasma by high performance liquid chromatographic method using monolithic column application to pharmacokinetic studies. J Bioequiv 2010; 2: 135-8.
[http://dx.doi.org/10.4172/jbb.1000046]
[37]
Vaghela A, Patel A, Vyas A. Sample preparation in bioanalysis: a review. Int J Sci Technol Res 2016; 5: 6-10.
[38]
Parmar G, Pundarikakshudu K, Balaraman R. Anti-anaphylactic and antiasthmatic activity of Euphorbia thymifolia L. on experimental animals. J Tradit Complement Med 2018; 9(1): 60-5.
[http://dx.doi.org/10.1016/j.jtcme.2018.03.002] [PMID: 30671367]
[39]
Patil SD, Ninave PB. In-vivo and in-vitro screening models of asthma: an overview Int. J Res Dev Pharm L Sci 2016; 5(9): 2209-18.
[40]
Wu AY, Chik SC, Chan AW, Li Z, Tsang KW, Li W. Anti-inflammatory effects of high-dose montelukast in an animal model of acute asthma. Clin Exp Allergy 2003; 33(3): 359-66.
[http://dx.doi.org/10.1046/j.1365-2222.2003.01615.x] [PMID: 12614451]
[41]
Polat A, Canbora MK, Akakin D, Aykanat F. Effects of montelukast sodium on tendon healing: An experimental study. Indian J Orthop 2013; 47(5): 500-4.
[http://dx.doi.org/10.4103/0019-5413.118207] [PMID: 24133311]
[42]
de Almeida Gonçalves G, de Sá-Nakanishi AB, Wendt MMN, et al. Green tea extract improves the oxidative state of the liver and brain in rats with adjuvant-induced arthritis. Food Funct 2015; 6(8): 2701-11.
[http://dx.doi.org/10.1039/C5FO00548E] [PMID: 26146010]
[43]
Sahu N, Mishra G, Chandra HK, Nirala SK, Bhadauria M. Propolis modulates cellular biochemistry, antioxidants, cytokine profile histological and ultra-morphological status against antituberculosis drugs induced hepatic injury. Asian Pac J Trop Med 2018; 11(11): 609-20.
[http://dx.doi.org/10.4103/1995-7645.246337]
[44]
Gupta I, Shetti A, Keluskar V, Bagewadi A. Assessment of serum enzymatic antioxidant levels in patients with recurrent aphthous stomatitis: A case control study. Enzyme Res 2014; 2014: 340819.
[http://dx.doi.org/10.1155/2014/340819] [PMID: 25574385]
[45]
Antwi AO, Obiri DD, Osafo N. Stigmasterol modulates allergic airway inflammation in guinea pig model of ovalbumin-induced asthma. Mediators Inflamm 2017; 2017: 2953930.
[http://dx.doi.org/10.1155/2017/2953930] [PMID: 28555089]
[46]
Alici EH, Arabaci G. Determination of SOD, POD, PPO and CAT enzyme activities in Rumex obtusifolius L. Annu Res Rev Biol 2016; 11(3): 1-7.
[http://dx.doi.org/10.9734/ARRB/2016/29809]
[47]
Rahman I, Kode A, Biswas SK. Assay for quantitative determination of glutathione and glutathione disulfide levels using enzymatic recycling method. Nat Protoc 2006; 1(6): 3159-65.
[http://dx.doi.org/10.1038/nprot.2006.378] [PMID: 17406579]
[48]
Salama A, Hegazy R, Hassan A. Intranasal chromium induces acute brain and lung injuries in rats: Assessment of different potential hazardous effects of environmental and occupational exposure to chromium and introduction of a novel pharmacological and toxicological animal model. PLoS One 2016; 11(12): e0168688.
[http://dx.doi.org/10.1371/journal.pone.0168688] [PMID: 27997619]
[49]
Li S, Aliyeva M, Daphtary N, et al. Antigen-induced mast cell expansion and bronchoconstriction in a mouse model of asthma. Am J Physiol Lung Cell Mol Physiol 2014; 306(2): L196-206.
[http://dx.doi.org/10.1152/ajplung.00055.2013] [PMID: 24285269]
[50]
Farokhi F, Khaneshi F. Histophatologic changes of lung in asthmatic male rats treated with hydro-alcoholic extract of Plantago major and theophylline. Avicenna J Phytomed 2013; 3(2): 143-51.
[PMID: 25050268]
[51]
Kim HJ, Lee SH, Lim EA, Kim JS. Formulation optimization of solid dispersion of mosapride hydrochloride. Arch Pharm Res 2011; 34(9): 1467-75.
[http://dx.doi.org/10.1007/s12272-011-0908-3] [PMID: 21975808]
[52]
Fey C, Thyroff-Friesinger U, Jones S. Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults. Clin Transl Allergy 2014; 4(29): 29.
[http://dx.doi.org/10.1186/2045-7022-4-29] [PMID: 25250173]
[53]
Galgatte UC, Jamdade VR, Aute PP, Chaudhari PD. Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada. Saudi Pharm J 2014; 22(5): 391-402.
[http://dx.doi.org/10.1016/j.jsps.2013.05.001] [PMID: 25473327]
[54]
Qu J, Li Y, Zhong W, Gao P, Hu C. Recent developments in the role of reactive oxygen species in allergic asthma. J Thorac Dis 2017; 9(1): E32-43.
[http://dx.doi.org/10.21037/jtd.2017.01.05] [PMID: 28203435]
[55]
Comhair SA, Erzurum SC. Redox control of asthma: molecular mechanisms and therapeutic opportunities. Antioxid Redox Signal 2010; 12(1): 93-124.
[http://dx.doi.org/10.1089/ars.2008.2425] [PMID: 19634987]
[56]
Singh S, Verma SK, Kumar S, et al. Evaluation of oxidative stress and antioxidant status in chronic obstructive pulmonary disease. Scand J Immunol 2017; 85(2): 130-7.
[http://dx.doi.org/10.1111/sji.12498] [PMID: 28256060]
[57]
Ahmad A, Shameem M, Husain Q. Relation of oxidant-antioxidant imbalance with disease progression in patients with asthma. Ann Thorac Med 2012; 7(4): 226-32.
[http://dx.doi.org/10.4103/1817-1737.102182] [PMID: 23189100]
[58]
Cruse G, Bradding P. Mast cells in airway diseases and interstitial lung disease. Eur J Pharmacol 2016; 778: 125-38.
[http://dx.doi.org/10.1016/j.ejphar.2015.04.046] [PMID: 25959386]
[59]
Chai OH, Han EH, Lee HK, Song CH. Mast cells play a key role in Th2 cytokine-dependent asthma model through production of adhesion molecules by liberation of TNF-α. Exp Mol Med 2011; 43(1): 35-43.
[http://dx.doi.org/10.3858/emm.2011.43.1.004] [PMID: 21169725]
[60]
Kuzubova NA, Lebedeva ES, Titova ON, Fedin AN, Dvorakovskaya IV. Role of mast cells in bronchial contraction in nonallergic obstructive lung pathology. J Smooth Muscle Res 2017; 53(0): 90-9.
[http://dx.doi.org/10.1540/jsmr.53.90] [PMID: 28867718]
[61]
Hauck WW, Parekh A, Lesko LJ, Chen ML, Williams RL. Limits of 80%-125% for AUC and 70%-143% for Cmax. What is the impact on bioequivalence studies? Int J Clin Pharmacol Ther 2001; 39(8): 350-5.
[http://dx.doi.org/10.5414/CPP39350] [PMID: 11515710]
[62]
Liu MZ, Zhang YL, Zeng MZ, et al. Pharmacogenomics and herb-drug interactions: Merge of future and tradition. Evid Based Complement Alternat Med 2015; 2015: 321091.
[http://dx.doi.org/10.1155/2015/321091] [PMID: 25821484]
[63]
Koziolek M, Alcaro S, Augustijns P, et al. The mechanisms of pharmacokinetic food-drug interactions - A perspective from the UNGAP group. Eur J Pharm Sci 2019; 134: 31-59.
[http://dx.doi.org/10.1016/j.ejps.2019.04.003] [PMID: 30974173]
[64]
Choi JH, Ko CM. Food and drug interactions. J Lifestyle Med 2017; 7(1): 1-9.
[http://dx.doi.org/10.15280/jlm.2017.7.1.1] [PMID: 28261555]
[65]
Zhou S, Gao Y, Jiang W, Huang M, Xu A, Paxton JW. Interactions of herbs with cytochrome P450. Drug Metab Rev 2003; 35(1): 35-98.
[http://dx.doi.org/10.1081/DMR-120018248] [PMID: 12635815]
[66]
Ramos-Ramírez P, Campos MG, Martínez-Cordero E, et al. Neutrophilia induced by histamine challenge in guinea pig: The role of IL-5, IL-10 and IL-17A, but not CXCL8. Bol Méd Hosp Infant México 2014; 71(2): 83-7.
[67]
Kajaria D, Tripathi JS, Tiwari SK, Pandey BL. Anti-histaminic, mast cell stabilizing and bronchodilator effect of hydroalcoholic extract of polyherbal compound- Bharangyadi. Anc Sci Life 2012; 31(3): 95-100.
[http://dx.doi.org/10.4103/0257-7941.103182] [PMID: 23284214]
[68]
Kudo M, Ishigatsubo Y, Aoki I. Pathology of asthma. Front Microbiol 2013; 4: 263.
[http://dx.doi.org/10.3389/fmicb.2013.00263] [PMID: 24032029]
[69]
Méndez-Enríquez E, Hallgren J. Mast cells and their progenitors in allergic asthma. Front Immunol 2019; 10: 821.
[http://dx.doi.org/10.3389/fimmu.2019.00821] [PMID: 31191511]

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