Volume : 10, Issue : 01, January – 2023
Title:
59.CHARACTERIZATION OF BI-LAYERED TABLET FOR TREATING HEPATOTOXICITY CAUSED BY ANTITUBERCULAR DRUG FOR THE EFFECTIVE MANAGEMENT OF TUBERCULOSIS.
Authors :
Shreya Tripathi *, Sailesh kumar Ghatuary, Satkar Prasad, Satyawan Dangi
Abstract :
The proposed study aimed at development and characterization of bi-layered tablet for treating hepatotoxicity caused by antitubercular drug for the effective management of tuberculosis. Isoniazid is first line antitubercular drug which acts via inhibiting InhA and KasA genes. Based on its solubility and log P values, drug was found to be hydrophilic in nature. Isoniazid is first line drug due to its high efficacy but major disadvantage associated with this drug is hepatotoxicity. Due to this drawback there are various chances to discontinue the therapy. Hence, to prevent this discontinuation silymarin, a herbal hepatoprotective drug can be used in combination with isoniazid.
Isoniazid was obtained as white, crystalline powder and its melting point was found to be in 161ºC-164º C range. It has maximum absorbance at 261nm and endothermic DSC peak at 163ºC. Based on solubility profile and log P value, amphiphilic nature of Silymarin was determined. Silymarin was obtained as solid powder with maximum absorbance at 288 nm The drug content of bilayer tablet was estimated by simultaneous estimation method. Bilayer tablet was prepared by using HPMC, Carbopol, and cyclodextrin in optimum concentration. Prepared bilayer tablet was optimized for in vitro drug release in altered media. Then the formulation with higher sustained release was selected for bilayer tablet formulation.
Bilayer tablet was characterized on the basis of different parameters such as hardness, friability, weight variation, drug content and in vitro drug release. Drug release kinetics of silymarin from bilayer tablet was found to be Hixson Crowell mechanism whereas INH followed Higuchi diffusion model.
Key words: hepatotoxicity, antitubercular , tuberculosis, Isoniazid, amphiphilic nature.
Cite This Article:
Please cite this article in press Shreya Tripathi et al, Characterization Of Bi-Layered Tablet For Treating Hepatotoxicity Caused By Antitubercular Drug For The Effective Management Of Tuberculosis.,Indo Am. J. P. Sci, 2023; 10(01).
Number of Downloads : 10
References:
1. Quinonez CG, Lee JJ, Lim J, Odell M, Lawson CP, Anyogu A, Raheem S, Eoh H. The role of fatty acid metabolism in drug tolerance of Mycobacterium tuberculosis. Mbio. 2022 Jan 11;13(1):e03559-21.
2. Tabriz AG, Nandi U, Hurt AP, Hui HW, Karki S, Gong Y, Kumar S, Douroumis D. 3D printed bilayer tablet with dual controlled drug release for tuberculosis treatment. International Journal of Pharmaceutics. 2021 Jan 25; 593:120147.
3. Chakaya J, Khan M, Ntoumi F, Aklillu E, Fatima R, Mwaba P, Kapata N, Mfinanga S, Hasnain SE, Katoto PD, Bulabula AN. Global Tuberculosis Report 2020–Reflections on theGlobal TB burden, treatment and prevention efforts. International Journal of InfectiousDiseases. 2021 Dec 1; 113:S7-12.
4. Court R, Chirehwa MT, Wiesner L, de Vries N, Harding J, Gumbo T, Maartens G, McIlleron H. Effect of tablet crushing on drug exposure in the treatment of multidrug-resistant tuberculosis. The international journal of tuberculosis and lung disease: the official journal of the International Union against Tuberculosis and Lung Disease. 2019 Oct 1;23(10):1068.
5. Pepping J. Milk thistle: Silybum marianum . Am J Health Syst Pharm 1999;56:1195-7.
6. Genina N, Boetker JP, Colombo S, Harmankaya N, Rantanen J, Bohr A. Anti-tuberculosis drug combination for controlled oral delivery using 3D printed compartmental dosage forms: From drug product design to in vivo testing. Journal of controlled Release. 2017 Dec 28;268:40-8.
7. Terracciano E, Amadori F, Zaratti L, Franco E, ‘Tuberculosis: an ever present disease but difficult to prevent’. Igiene e sanita pubblica. 2020 Jan-Feb
8. Perrier S.; Lunn A.; Unnikrishnan M.,” Dual pH-Responsive Macrophage-Targeted Isoniazid
Glycoparticles for Intracellular Tuberculosis Therapy” Biomacromolecules 2021, 2022,
9. A. Matteelli, A. Roggi, A.C. Carvalho, Extensively drug-resistant tuberculosis: epidemiology and management, Clin. Epidemiol. 6 (2014) 111–118.
10. J. Deacon, S.M. Abdelghany, D.J. Quinn, D. Schmid, J. Megaw, R.F. Donnelly, et al.,Antimicrobial efficacy of tobramycin polymeric nanoparticles for Pseudomonas aeruginosa infections in cystic fibrosis: formulation, characterization and functionalization with dornase alfa (DNase), J. Control. Release: official journal of the Controlled Release Society 198 (2015) 55–61.
11. K.Dua, R. Awasthi, J.R. Madan, D.K. Chellappan, B.N. Nalluri, G. Gupta, M. Bebawy, P.M. Hansbro, Novel drug delivery approaches in treating pulmonary fibrosis, Panminerva Med. (2018)
12. S.G. Mpagama, N. Ndusilo, S. Stroup, H. Kumburu, C.A. Peloquin, J. Gratz, et al., Plasma drug activity in patients on treatment for multidrug-resistant tuberculosis, Antimicrob. Agents Chemother. 58 (2014) 782– 788.
13. Bhardwaj A., Mehta S., Yadav S.,Singh S.,Anne Grobler, Goyal A. & Mehta A.(2016) Pulmonary delivery of antitubercular drugs using spray-dried lipid–polymer hybrid nanoparticles, Artificial Cells, Nanomedicine, and Biotechnology, 44:6, 1544-1555.
14. World Health Organization Global Tuberculosis Report 2020. https://www.who.int/publications/i/item/9789240013131