EVALUATION OF MECHANICAL STRENGTH AFTER COMPRESSION OF METFORMIN 500MG TABLETS PRODUCED BY DIFFERENT WET ROUTES
DOI:
https://doi.org/10.22159/ijpps.2021v13i3.40311Keywords:
Hardness, Post-compression, Povidone, Fluidized bed, V blenderAbstract
Objective: This work evaluated the post-compression hardness gain of Metformin tablets made from two granulates of the same formulation, but with different formation principles, one by the fluidized bed and the other in a V-shaped mixer.
Methods: The base granulate for the production of the tablets was prepared using Metformin HCL as the main active ingredient. After compression, the prepared tablets were tested with different evaluation parameters like relative humidity, apparent and compacted density, granulometric dispersion, hardness, moisture content, and friability for complete characterization.
Results: All prepared samples were within the pre-established humidity ranges (MT1 = 3.31%, MT2 = 2.72%, MT3 = 1.73%, LF1 = 3.25%, LF2 = 2.43% and LF3 = 1.79%). The density determination showed that the granules produced in the fluidized bed are less dense than those of the V mixer. LF2 sample had an apparent density of 0.525 g/ml and a compacted density of 0.546 g/ml, while the MT2 sample had an apparent density of 0.711 g/ml and a compacted density of 0.738 g/ml, corroborating the greater porosity of granules produced in a fluidized bed. It was found that there is a difference in the increase in hardness between the two granulation methods. The tablets manufactured from the granules elaborated in a V-shaped mixer showed a greater gain in comparison with those produced in the fluid bed. The MT1 sample had the highest gain percentage, reaching 99.47%, 48 h after compression. The MT2 sample obtained, for the same time, 76.34%, at a much slower speed than MT1. As for the other samples, all increased between 24 and 42%. These results are justified by the migration of agglutination liquid that occurs during the drying step.
Conclusion: This work demonstrated that the product Metformin 500 mg tablet has increased hardness after compression, with most significance in the first hour after the procedure. It was possible to verify that the tablets made from the granules produced in a V-shaped mixer have a greater increase in hardness than those produced by the fluidized bed, in the same humidity range.
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References
Srinivasan S. Granulation techniques and technologies: recent progresses. BioImpacts 2015;5:55–63.
P S, Tp A, Viswanad V. Formulation and evaluation of synthesized quinazolinone derivative for colon specific drug delivery. Asian J Pharm Clin Res 2017;10:207-12.
Rajesh A, Naveen Y. Pharmaceutical processing–a review on wet granulation technology. Int J Pharm Front Res 2011;1:65-83.
Ajit SN, Sherif IFB. editors. Handbook of pharmaceutical wet granulation-theory and practice in a quality by design paradigm. Cambridge (MA): Academic Press; 2019.
Le Hir A. Abrege de pharmecie galenique–formes pharmaceutiques. 5th ed. Paris: Masson; 1997.
R VB. Design and development of gastroretentive drug delivery system of ciprofloxacin hydrochloride. Asian J Pharm Clin Res 2018;11:141-6.
Séverine TFCM, Thomas DB, Krist VG, Jean PR, Chris V, Ingmar N. Mechanistic modelling of fluidized bed drying processes of wet porous granules: a review. Eur J Pharm Biopharm 2011;79:205-25.
Jelena P, Krisanin C, Brigitte M, Svetlana I, Gabriele B. Analysis of fluidized bed granulation process using conventional and novel modeling techniques. Eur J Pharm Sci 2011;44:227-34.
Sioson AS, Earvin SCA, de Luna MDG, Huang YH, Lu MC. Calcium carbonate granulation in a fluidized-bed reactor: kinetic, parametric and granule characterization analyses. Chem Eng J 2020;44:122879.
Kim KMK, Pyo JS. A study of fluid bed granulation of pravastatin tablet using design of experiments. Asian J Pharm Clin Res 2018;11:410-4.
Leuenberger H. Granulation, new techniques. Pharm Acta Helv 1982;57:72-82.
Lachman L, Kanig JL, Lieberman HA. The theory and practice of industrial pharmacy. 3rd ed. Lisboa: Calouste Gulbenkian Fundation; 2015.
Suresh P, Sreedhar I, Vaidhiswaran R, Venugopal A. A comprehensive review on process and engineering aspects of pharmaceutical wet granulation. Chem Eng J 2017;328:785-815.
Chirkot T, Propst C. Low-shear granulation. In: Swarbrick J, Parikh DM. editors. Handbook of pharmaceutical granulation technology. Boca Raton (FL): Taylor and Francis Group; 2005.
Chowhan ZT, Palagyi L. Hardness increase induced by partial moisture loss in compressed tablets and its effect on in vitro dissolution. J Pharm Sci 1978;67:1385-9.
Chowhan ZT. Moisture, hardness, disintegration and dissolution interrelationships in compressed tablets prepared by the wet granulation process. Drug Dev Ind Pharm 1979;5:41-62.
Chowhan ZT, Amaro AA. Optimization of tablet friability, maximum attainable crushing strength, weight variation and in vitro dissolution by establishing in-process variable controls. Drug Dev Ind Pharm 2008;14:1079-106.
Jain P, Gupta RN, Shrivastava S. Formulation and evaluation of mouth dissolving tablets of omeprazole. Int J Curr Pharm Sci 2016;8:48-51.
Brazilian Pharmacopoeia-National Health Surveillance Agency (ANVISA). 5th ed. Brasília; 2010.
Kibbe AH. Handbook of pharmaceutical excipients. 3rd ed. Washington (DC): American Pharmaceutical Association; 2000.
Aulton ME, Tayloy KMG. The design and manufacture of medicines. 5th ed. Porto Alegre: Elsevier; 2017.
Nokhodchi A, Javadzadeh Y. The effect of storage conditions on the physical stability of tablets. Pharm Technol Eur 2007;19:20-6.
Mettler Toledo GmbH. Guide to moisture analysis-Fundamentals and applications. Switzerland; 2016. Available from: https://www.mt.com/de/en/home/library/guides/laboratory-weighing/guide-to-moisture-analysis.html [Last accessed on 18 Nov 2020].
Etman ME, Mahmoud EH, Galal S, Nada AH. Floating ranitidine microparticulates: development and in vitro evaluation. Int J Appl Pharm 2016;8:1-9.
Chaud MV, Lima AC, Michelin D, Santos MR, Paganelli M, Ignacio R. Efeito da força de compressao e da umidade no perfil de dissolucao de farmacos. Saude em Revista 2005;7:39-43.
Thapa P, Lee AR, Choi DH, Jeong SH. Effects of moisture content and compression pressure of various deforming granules on the physical properties of tablets. Powder Technol 2017;310:92-102.
Gabbott IP, Husban FA, Reynolds GK. The combined effect of wet granulation process parameters and dried granule moisture content on tablet quality attributes. Eur J Pharm Biopharm 2016;106:70-8.
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