FORMULATION AND EVALUATION OF MOUTH DISSOLVING TABLET OF AMLODIPINE BESYLATE
DOI:
https://doi.org/10.22159/ijap.2019v11i4.31288Keywords:
Mouth dissolving tablet, Amlodipine besylate, Superdisintegrants, Bioavailability, Calcium channel blockerAbstract
Objective: The main objective of this research work was to formulate and evaluate the mouth dissolving tablet of amlodipine besylate for the treatment of hypertension and coronary artery disease.
Methods: In this study, mouth dissolving tablet were prepared by direct compression method by using croscarmellose sodium and sodium starch glycolate as superdisintegrants. The designed tablets were subjected to various assessment parameters like friability test, hardness test, disintegration test, wetting time, in vitro drug release and drug content.
Results: All the prepared formulations were subjected to various assessment parameters, and the findings obtain within the prescribed limit. The calibration curve of pure drug using various solvents like phosphate buffer pH 6.8, methanol was plotted. F1-F9 containing croscarmellose sodium and sodium starch glycolate in various concentration demonstrate the minimum disintegration time. Among all these formulations F9 shows disintegration time up to 22±1.12 seconds due to the high concentration of superdisintegrants. In vitro drug release was tested in phosphate buffer pH 6.8 at a time interval of 0, 1, 2, 3, 4, 5 min. The F9 shows drug release 100.22±1.08%. Accelerated stability study of optimized formulation (F9) up to 2 mo showed there was no change in disintegration time and percentage drug release.
Conclusion: The results obtained in the research work clearly showed a promising potential of mouth dissolving tablets containing a specific ratio of croscarmellose sodium and sodium starch glycolate as superdisintegrants for the effective treatment of hypertension and coronary artery disease.
Downloads
References
Seager H. Drug delivery products and the zydis fast dissolving dosage form. J Pharm Pharmacol 1998;4:375-82.
Prajapati BG, Patel B. Formulation, evaluation and optimization of orally disintegrating tablet of piroxicam. Int J Pharma Tech Res 2010;2:1893-9.
Patidar A, Mishra P, Main P, Harsoliya MS, Agrawal S. A review on recent advancement in the development of rapid disintegrating tablet. Pharm Sci Pharm 2011;1:7.
Sastry SV, Nyshadham JR, Fıx JA. Recent technological advances in oral drug delivery. A review. Pharm Sci Technol Today 2000;3:138–45.
Habib W, Khankari RK, Hontz J. Fast-dissolve drug delivery systems. Crit Rev Ther Drug Carrier Sys 2000;2:61–72.
Lindgren S, Janzon L. Dysphagia: prevalence of swallowing complaints and clinical finding. Med Clin North Am 1993;6:3–5.
Muhammad AS, Syed FA, Marium FK, Sofia A, Iqbal A. Formulations of amlodipine: a review. J Pharm 2016;1-11. http://dx.doi.org/10.1155/2016/8961621
Deepthi PR, Satish KK. Formulation and evaluation of amlodipine besylate oral thin films. Int J Pharma Sci Res 2016;7:199-205.
Shireen B, Syed AAB, Shazia F. Formulation and in-vitro evaluation of mouth dissolving tablets of amlodipine and rosuvastatin. Int J Curr Pharm Res 2015;7:88-91.
Nirav VP, Sachin C, Chintan Aundhia, Seth AK. Formulation and evaluation of amlodipine besylate orally disintegrating tablet. Indo Am J Pharma Res 2011;2:146-52.
Vijaya VCS, Vidyavathi M. Preparation and in vitro characterization of bosentan monohydrate mucoadhesive microspheres. Eur J Pharma Med Res 2016;3:340-50.
Chatwal GR, Anand SK. Instrumental methods of instrumental methods of chemical analysis. 5th Edition. Himalaya Publishing House; 2009. p. 2.49-2.51.
Nirav VP, Sachin C, Chintan Aundhia, Seth AK. Formulation and evaluation of amlodipine besylate orally disintegrating tablet. Indo Am J Pharma Res 2011;2:146-52.
Bele MH. Pharmaceutics formulation and processing of conventional dosage form. First Edition. Carrer Publication; 2012. p. 48-55, 128-131.
Kalia A, Khurana S, Bedi N. Formulation and evaluation of mouth dissolving tablet of oxcarbazepine. Int J Pharm Pharm Sci 2009;1:12-3.
Jain C, Naruka P. Formulation and evaluation of fast dissolving tablet of valsartan. Int J Pharm Pharm Sci 2009;1:219-26.
Indian Pharmacopoeia. Government of India Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeal Commission, Ghaziabad; 2014. p. 2964, 1469, 2143, 2151.
Sudhir B, Vinay J, Jar RC, Ashish M, Suman J. Formulation and evaluation of fast dissolving tablets of aceclofenac. Int J Drug Delivery 2010;2:93-7.
Kuchekar B, Badhan A, Mahajan H. Mouth dissolving tablets of salbutamol sulphate: a novel drug delivery system. Indian Drugs 2004;41:592–8.
Arunachalam A, Lavakumar V, Shankar M. Formulation and in vitro evaluation of levofloxacin oral dispersible tablets. Asian J Res Chem Pharm Sci 2013;1:31-9.
Dobetti L. Fast melting tablet: development and technologies. Pharm Tech 2001;2:44-8.
Lorenzp Lamosa ML, Cuna M, Vila Jato JL, Torres D. Fast dissolving drug delivery system. J Microencapsul 1997;14:607.
Virley P, Zydis YR. A novel fast dissolving dosage form. Manuf Chem 1990;2:36-7.
Shinkar DM, Aher PS, Kothwade PD, Maru AD. Formulation and in vitro evaluation of verapamil hydrochloride. Int J Pharm Pharm Sci 2018;10:93-9.
Caretensen JT. Guidelines for drug stability: principles and practices. Third Edition. Marcel Dekkar; 2005. p. 252-5.
Pratik SD, Sushma V, Puja S. Fast dissolving tablet using solid dispersion technique: a review. Int J Curr Pharm Res 2017;9:1-4.
Roy A. Orodispersible tablet: a review. Asian J Pharm Chem Res 2016;2:19-26.
Jaya S, Amala V. Formulation and in vitro evaluation of oral disintegrating tablets of amlodipine besylate. Int J Appl Pharm 2019;11:49-54.
Published
How to Cite
Issue
Section
