STUDY OF THE FUNCTIONALITY OF A NOVEL SOLUTION BINDER OBTAINED FROM OCIMUM BASILICUM SEEDS: A MECHANISTIC APPROACH
DOI:
https://doi.org/10.22159/ijap.2020v12i6.36987Keywords:
Solution binder, Paracetamol, CompactibilityAbstract
Objective: The aim of the present study was to investigate the functionality of the hydrogel isolated from the seeds of Ocimum basilicum (Gel) as a novel solution binder.
Methods: Paracetamol is known to possess poor manufacturability. Therefore it was selected as a model drug to study the efficiency of Gel as a solution binder. Paracetamol tablets were prepared at gradually increasing compression pressure from the granules prepared by using Gel of various viscosities as a solution binder. Compactibility parameter was calculated to assess the utility of Gel as a novel tablet binder. Optimization of the formulation was done by adopting factorial design as an appropriate DOE. Tablets of factorial batches were evaluated for disintegration time and crushing strength. The effect of viscosity of binder solution used to prepare granulation and compression pressure applied on granulation on the performance of the tablets was confirmed by analyzing the data using ANOVA.
Results: The addition of binder solution to prepare granulation with the viscosity ≥ 19.33 centipoises was found to be suitable to attain desired degree of agglomeration. The crushing strength of the tablets was found to be increased with an increase in compression pressure and an increase in viscosity of binder solution.
Conclusion: The compatibility parameter was observed to be increased as the viscosity of the binder solution added in the formulation was gradually increased. The Gel as a binder material was found to deform plastically at compression pressures 34.48 to 75.85 MPa. This confirmed its functionality as a solution binder in Paracetamol tablet preparation.
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Osamuta T, Takeuchi Y, Onodera R, Kitamura M, Takahashi Y, Tahara K, et al. Formulation design of granules prepared by wet granulation method using a multi-functional single punch tablet press to avoid tableting failures. Asian J Pharm 2018;13:113-9.
Cantor SL, Augsburger LL, Hoag SW. Pharmaceutical granulation processes, Mechanism, and the use of binders. In: Augsburger LL, Hoag SW. editors. Pharmaceutical dosage forms: Tablets. 3rd ed. Informa Healthcare: New York; 2008. p. 261-301.
Davies P. Oral solid dosage forms. In: Gibson M. editor. Pharmaceutical preformulation and formulation. 2nd ed. Interpharm/CRC: London; 2004. p. 379-458.
Phadke DS, Anderson NR. Effect of crosspovidone on the wet granulation aspects of acetaminophen. Drug Dev Ind Pharm 2008;16:983-94.
Ramachandran R, Poon JMH, Sanders CFW, Glaser T, Emmanuel CD, Doyle FJ III, et al. Experimental studies on distributions of granule size, binder content and porosity in batch drum granulation: inferences on process modelling requirements and process sensitivities. Powder Technol 2008;188:89-101.
Cryser I, Pope DG, Hersay JA. An evaluation of tablet binding agents, Part I: Solution binders. Powder Tech 1983;34:39-51.
Hoag SW, Dave VS, Moolchandani V. Compression and compaction. In: Augsburger LL, Hoag SW. editors. Pharmaceutical dosage forms: tablets. 3rd ed. Informa Healthcare: New York; 2008. p. 555-630.
Bhosale AV, Hardikar SR, Pathak AA, Sabale RV. Investigation of hydrogel isolated from seeds of Ocimum basilicum as binder. Indian J Pharm Sci 2009;71:320-2.
Robert G, Theodore P, Sullivanb M. Regulation of pharmaceutical excipients. In: Excipient development for pharmaceutical, biotechnology, and drug delivery systems. Katdare A, Chaubal MV. Informa Healthcare: New York; 2006. p. 37-50.
Garekani HA, Ford JL, Rubinstein MH, Siahboomi ARR. Effect of compression force, compression speed and particle size on the compression properties of paracetamol. Drug Dev Ind Pharm 2001;27:935-42.
Chitu TM, Oulahna D, Hemati M. Wet granulation in laboratory scale high shear mixers; effect of binder properties. Powder Tech 2011;206:25-33.
Obraniak A, Orczykowska M, Olejnik TP. The effect of viscoelastic properties of the wetting liquid on the kinetics of the disc granulation process. Powder Tech 2019;342:328-34.
Knight P. Challenges in granulation technology. Powder Tech 2004;140:156-62.
Johansen A, Schaefer T. Effects of interactions between powder particle size and binder viscosity on agglomerate growth mechanisms in a high shear mixer. Eur J Pharm Sci 2001;12:297-309.
Sonnergaard JM. Quantification of the compactibility of pharmaceutical powders. Eur J Pharm Biopharm 2006;63:270-7.
Tye CK, Sun C, Amidon GE. Evaluation of the effects of tableting speed on the relationships between compaction pressure, tablets tensile strength, and solid tablet fraction. J Pharm Sci 2005;94:465-72.
Kipo SL, Oppong EE, Ofori Kwakye K. Physicochemical evaluation and tablet formulation properties of shea tree gum. Asian J Pharm Clin Res 2014;7:121-7.
Leunar C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Euro J Pharm Biopharm 2000;50:47-60.
Tan BMJ, Loh ZH, Soh JLP, Liew CV, Heng PWS. Distribution of a viscous binder during high shear granulation-sensitivity to the method of delivery and its impact on product properties. Int J Pharm 2014;460:255-63.
Patrick CK, Ali MS, Josiah OD, Walyambillah W, Leonard MG. Effect of granule size, compaction pressure and concentration of M. verticillata mucilage on the in vitro properties of tablets. Int J Pharm Pharm Sci 2018;10:26-31.
IPEC. Qualification of excipients for use in pharmaceuticals; 2008. Available from: http://ipecamericas.org/sites/ [Last accessed on 12 Sep 2014]
Dave VS, Saoji SD, Raut NA, Havre RV. Excipient variability and its impact on dosage form functionality. J Pharm Sci 2015;104:906-15.
Barhate S, Husain M. Development of hydrophillic matrix tablet of carbamaZepine using 33 full factorial designs. Int J Pharm Pharm Sci 2015;7:369-75.
Pai DA, Hayes AA, Okos MR. Modeling pharmaceutical compacts tensile strength based on viscoelastic properties. Powder Tech 2013;239:441-50.
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