Author(s):
Bipin Gandhi, Ajay Bhagwat, Swarup Matkar, Anant Kuchik, Tejal Wale, Onkar Kokane, Nitin Rode
Email(s):
bipingandhi012@gmail.com
DOI:
10.52711/0974-360X.2025.00291
Address:
Bipin Gandhi1*, Ajay Bhagwat2, Swarup Matkar3, Anant Kuchik3, Tejal Wale3, Onkar Kokane3, Nitin Rode3
1Associate Professor, Department of Pharmaceutics, Samarth College of Pharmacy, Belhe, Pune.
2Assistant Professor, Department of Pharmaceutics, Samarth College of Pharmacy, Belhe, Pune.
3Student, Department of Pharmaceutics, Samarth College of Pharmacy, Belhe, Pune.
*Corresponding Author
Published In:
Volume - 18,
Issue - 5,
Year - 2025
ABSTRACT:
The current study concentrated about development and the in vitro assessment of a bilayer tablet with a particular dosage containing two well-known hypertension medications, amlodipine and atenolol. Using varying percentages of the sodium starch glycolate and polyvinylpyrrolidone as super-disintegrants to promote blood pressure-lowering activity, tablets were developed to release atenolol. (A1-A4) immediately. The tablets were also structured to sustain the release of amlodipine (B1-B4) by changing the proportion of hydroxypropyl methylcellulose (HPMC) and anhydrous DCP for prolonged activity. The United States Pharmacopoeia (USP) guidelines were referred to evaluate thechemical and physical propertiesof formulations. The results indicated that the best immediate release formulation exhibited 100% dissolution after 45 minutes later, along with other tablet characteristics such as hardness, disintegration time, and powder flowing properties. Nonetheless, disintegration (100% after twenty four hours with consistent release) and some tablet features are demonstrated by the best sustained release formulation. After formulation adjustment, the atenolol as well as amlodipine components were both effectively compressed as a bilayer tablets, and compression properties were determined. After 45 minutes, the bilayer tablet's atenolol was reported to be 100% released in 0.1 N HCl media, but amlodipine was 100% released in phosphate buffer medium after twenty four hours.
Cite this article:
Bipin Gandhi, Ajay Bhagwat, Swarup Matkar, Anant Kuchik, Tejal Wale, Onkar Kokane, Nitin Rode. Formulation and Evaluation of Bilayer Tablets of Atenolol and Amlodipine for the Treatment of Hypertension. Research Journal of Pharmacy and Technology. 2025;18(5):2037-2. doi: 10.52711/0974-360X.2025.00291
Cite(Electronic):
Bipin Gandhi, Ajay Bhagwat, Swarup Matkar, Anant Kuchik, Tejal Wale, Onkar Kokane, Nitin Rode. Formulation and Evaluation of Bilayer Tablets of Atenolol and Amlodipine for the Treatment of Hypertension. Research Journal of Pharmacy and Technology. 2025;18(5):2037-2. doi: 10.52711/0974-360X.2025.00291 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-5-14
REFERENCES:
1. Bangalore, S., Kamalakkannan, G., Parkar, S. and Messerli, F.H. 2007. Fixed-dose combinations improve medication compliance: a meta-analysis. Am. J. Med.120, 713-719.
2. Cushman WC, Ford CE, Cutler JA, et al.; ALLHAT Collaborative Research Group. Success and predictors of blood pressure control in diverse North American settings: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertension (Greenwich). 2002; 4(6): 393-404.
3. Jones JK, Gorkin L, Lian JF, et al: Discontinuation ofand changes in treatment after start of new courses of antihypertensive drugs: a study of a United Kingdom population. Br Med J 1995; 311: 293–295.
4. Chobanian, A.V., Bakris, G.L., Black, H.R., Cushman, W.C., Green, L.A., Izzo Jr, J.L., Jones, D.W., Materson, B.J., Oparil, S., Wright Jr, J.T. and Roccella, E.J. 2003. The seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure: the JNC 7 report J. Am. Med. Assoc. 289, 2560-2571.
5. P. Sumathy, Manukonda Monika. A Prospective Study on Comparative Efficacy between three Combinational Therapies for Hypertension. Research J. Pharm. and Tech. 2017; 10(1): 273-276.
6. A Prospective Study on Comparative Efficacy Between Two Combinational Therapies for Hypertension. Research J. Pharm. and Tech. 2016; doi: 10.5958/0974-360X.2017.00056.7
7. Padilla MC, Armas-Hernández MJ, Hernández RH, Israili ZH, Valasco M. Update on diuretics in the treatment of hypertension. Am J Ther. 2007; 14(2): 154-160.
8. Weir MR, Crikelair N, Levy D, Rocha R, Kuturu V, Glazer R. Evaluation of the dose response with valsartan and valsartan/hydrochlorothiazide in patients with essential hypertension. J Clin Hypertens (Greenwich). 2007; 9(2):103-112.
9. Sowers JR, Neutel JM, Saunders E, et al., for the INCLUSIVE Investigators. Antihypertensive efficacy of Irbesartan/HCTZ in men and women with the metabolic syndrome and type 2 diabetes. J Clin Hypertens (Greenwich). 2006; 8(7):470-480.
10. Hair PI, Scott LJ, Perry CM. Fixed-dose combination lercanidipine/enalapril. Drugs. 2007;67(1):95-106.
11. Nash DT. Systolic hypertension. Geriatrics. 2006;61(12):22-28.
12. Brown, H.C., Carruthers, S.G., Johnston, G.D., Kelly, J.G., McAinsh, J., McDevitt, D.G. and Shanks, R.G. 1976. Clinical pharmacologic observations on atenolol, a beta-adrenoceptor blocker. Clin. Pharmacol. Ther. 20, 524-534.
13. Spedding, M. and Paoletti, R. 1992. Classification of calcium channels and the sites of action of drugs modifying channel function. Pharmacol. Rev. 44, 363-376.3. L. Xu, F-M. Shen, H. Shu, C-Y. Miao, Y-Y. Jiang and D-F. Su, Synergism of atenolol and amlodipine on lowering and stabilizing blood pressure in spontaneously hypertensive rats, Fund.Clin. Pharmacol. 18 (2004) 33–38.
14. Diksha Sharma, Dinesh Kumar Mehta, Karun Bhatti, Rina Das, Ram Mohan Chidurala. Amlodipine And Atenolol: Combination Therapy Versus Monotherapy in Reducing Blood Pressure - A Focus on Safety and Efficacy. Research J. Pharm. and Tech 2020; 13(6): 3007-3013; doi: 10.5958/0974-360X.2020.00532.6
15. Ryakala, H., Dineshmohan, S., Ramesh, A. and Gupta, V.R.M. 2015. Formulation and in vitro evaluation of bilayer tablets of nebivolol hydrochloride and nateglinide for the treatment of diabetes and hypertension. J. Drug Delivery. Article ID 827859.http://dx.doi.org/10.1155/2015/827859.
16. Musharraf Chauhan, Shakti Suthar, Ankur Shah, Misam Polara, Manish Patel, Jayvadan Patel. Bilayer tablet: Immediate Release and Sustain Release: A Review. Research J. Pharm. and Tech. 5(6): June 2012; Page 716-720.
17. Sonali Joshi, Aarti Jaybhaye, Ganesh Deshmukh. Bilayer Tablet Technology: A Novel Approach. Research J. Pharm. and Tech. 6(12): Dec. 2013; Page 1443-1451
18. Hemant Mourya, Rajendra Chauhan, Ramakant Joshi, Wasim Akram, Navneet Garud. Bilayer Tablets: A Promising Novel Drug Delivery System. Research Journal of Pharmacy and Technology 2023; doi: 10.52711/0974-360X.2023.00414
19. Handbook of Pharmaceutical Excipients – Ninth Edition; Edited by Paul J Sheskey, Bruno C Hancock, Gary P Moss, David J Goldfarb
20. Borra Vamsi, Hemanth Kumar S, Patel P R, Gowrav M P, Vendor Qualification and Evaluation in Pharmaceutical Industry, International Journal of Research in Pharmaceutical Sciences. 2020; 11(2).
21. U. Annapurna, K. Sai Priyanka. Bilayer Tablets - A Review. Research J. Pharm. and Tech. 2019; doi: 10.5958/0974-360X.2019.00070.2
22. European Journal Pharmaceutical and Medical Research. 2022; 4(11): 526-530
23. Dhanish Joseph, Golda Maria Thomas. A Review on Current Applications of Bilayer Tablets. Research J. Pharm. and Tech. 2019 doi: 10.5958/0974-360X.2019. 00427.X
24. Int. J. Pharm. Sci. Rev. Res. 2021; 70(1): Article No. 05, Pages: 28-38
25. International Journal of Research Publication and Reviews, Vol 4, no 10, pp 1990-1999 October 2023
26. Shyamaladevi D., S. Suresh Kumar. Formulation and Evaluation of Bilayer Tablets of Montelukast Sodium Immediate Release and Doxofylline Sustained Release. Research J. Pharm. and Tech. 2013; 6(12): 1370-1374.
27. USP-29 NF 24 Page No. 2704
28. Journal of Drug Delivery Science and Technology; Volume 60, December 2020, 102079
29. USP29–NF24 Page 3046
30. International Journal of Pharmaceutical Sciences and Research (2019), Volume 10, Issue 8
31. R.Z. Mujoriya, Venkateshvarlu, D.C. Singh, V.A. Gupta, A Bisen, A.B. Bondre. Formulation Development and Evaluation of Metoprolol Succinate ER and Amlodipine Besilate Bilayer Tablet. Research J. Pharm. and Tech. 2010; 3(4): 1291-1294.
32. International Journal of Advances in Pharmaceutical Research. 2022 6(4):1209-1213
33. Zhang SQ, Rahman Z, Thumma S, Repka MA, Chen GH, Li SM. Development and evaluation of a pH-dependent sustained release tablet for irritable bowel syndrome. Drug Dev Ind Pharm. 2009 Jan; 35(1): 57-64. doi: 10.1080/03639040802178151. PMID: 19031287; PMCID: PMC5629918.
34. Indian Pharmacopoeia 2018; Volume II; Page no.1119
35. U. Annapurna, K. Sai Priyanka. Bilayer Tablets - A Review. Research J. Pharm. and Tech. 2019; 12(1): 385-390. doi: 10.5958/0974-360X.2019.00070.2