Quantifying the effect of glidanton the compaction and tableting properties of paracetamol granules
Quantifying the effect of glidanton the compaction and tableting properties of paracetamol granules
Glidants play a vital role in tablet formulation. This study aimedto examine the impact of glidants on the compaction and tabletingproperties of paracetamol granules prepared by wet granulation.Three formulations of paracetamol granules were prepared to consistof either talc, colloidal silicon dioxide (CSD) or a combination of both in equal proportion (1:1) as glidants added extragranularly. The granules were characterised by measuring the particle size, angle of repose, bulk and tapped densities, true densities,and moisture content. Compaction studies on the granules werecarried out using the Heckel, Kawakita, Walker,and compressibility-tabletability-compactibility (CTC) models. Tablets were prepared from the granules for each formulationand evaluated according to USP requirements.The results of the granule analysis revealed that granule properties were similar across the formulationsirrespective of the type of glidant used. Compaction studies revealed that talc granules exhibited a greater degree of plasticity and compressibility compared to the other formulations. However, CSD granules and granules containing the two glidants in equal proportion were found to have better compactibility and tabletability,resulting in tablets with relatively better properties. This study has underscored the impact of glidants on the compaction and tabletingproperties of paracetamol granules.
___
- [1]Chang R, Leonzio M, Hussain M, Hussain M. Effect of colloidal silicon dioxide on flowing and tableting properties of an experimental, crosslinked polyalkylammonium polymer. Pharm Dev Technol.1999;4:285–289. [CrossRef]
- [2]Jonat S, Hasenzahl S, Gray A, Schmidt P. Influence of compacted hydrophobic and hydrophilic colloidal silicon dioxide on tableting properties of pharmaceutical excipients. Drug Dev Ind Pharm. 2005; 31: 687–696. [CrossRef]
- [3]Wang J, Wen H, Desai D. Lubrication in tablet formulations. Eur J Pharm Biopharm.2010;75:1–15. [CrossRef]
- [4]Perrault M, Bertrand F, Chaouki J. An experimental investigation of the effect of the amount of lubricant on tablet properties. Drug Dev Ind Pharm.2011;37:234–242.[CrossRef]
- [5]Morin G, Briens L. The effect of lubricants on powder flowability for pharmaceutical application. AAPS PharmSciTech.2013;14:1158–1168.[CrossRef]
- [6]Zaman M.B. Pharm Thesis.Determination of variation in flow property of different formulas of lactose along with amlodipine and propranolol. Department of Pharmacy, East West University,Bangladesh,2016.
- [7]Osei-Yeboah F, Sun CC. Tabletability modulation through surface engineering. J Pharm Sci.2015;104:2645–2648. [CrossRef]
- [8]Müller A, Ruppel J, Drexel C, Zimmermann I. Precipitated silica as flow regulator. Eur J Pharm Sci.2008;34:303–308.[CrossRef]
- [9]Nurnberg E. Experimentelle Prüfungen von direct verpreßten Tablettengrundlagen. Pharm Ind.1972;34:193–206.
- [10]Rashid I, Al-Remawi M, Eftaiha A, Badwan A. Chitin-silicon dioxide coprecipitate as a novel superdisintegrant. J Pharm Sci.2008;97:4955–4969.[CrossRef]
- [11]Pingali K, Mendez R, Lewis D, Michniak-Kohn B, Cuitino A, Muzzio F. Mixing order of glidant and lubricant-Influence on powder and tablet properties. Int J Pharm.2011;409:269–277. [CrossRef]
- [12]Majerova D, Kulaviak L, Ruzicka M, Stepanek F, Zámostny P. Effect of colloidal silica on rheological properties of common pharmaceutical excipients. Eur J Pharm Biopharm.2016;106:2–8.[CrossRef]
- [13]Tran DT, Majerová D, Veselý M, Kulaviak L, Ruzicka MC, Zámostný P. On the mechanism of colloidal silica action to improve flow properties of pharmaceutical excipients. Int J Pharm.2019;556:383–394. [CrossRef]
- [14]Arora V, Gupta VB, Singhal R. Advances in direct compression technology. Pharma Times.2007;39:26–27.
- [15]Jadhav NR, Paradkar AR, Salunkhe NH, Karade RS, Mane GG. Talc: a versatile pharmaceutical excipient.World J Pharm Pharm Sci.2013;2:4639–4660.
- [16]Ariko NA. B. Pharm Thesis. Optimization of the extragranular component in paracetamol tablet formulation using Quality by Design. Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmaceutical Sciences, Ahmadu Bello University, Zaria, Nigeria, 2015.
- [17]Patel S, Kaushal AM, Bansal AK. The effect of starch paste and sodium starch glycolate on the compaction behavior of wet granulated acetaminophen formulations. J Excipients Food Chem.2011;2(3):64–72.
- [18]Osei-Yeboah F, Feng Y, Sun CC. Evolution of structure and properties of granules containing microcrystalline cellulose and polyvinylpyrrolidone during high-shear wet granulation. J Pharm Sci.2014;103:207–215. [CrossRef]
- [19]Patel S, Kaushal AM, Bansal AK. Compression physics in the formulation development of tablets. Crit Rev Ther Drug Carrier Syst.2006;23:1–65. [CrossRef]
- [20]Rahmouni M, Lenaerts V, Massuelle D, Doelker E, Leroux J. Influence of physical parameters and lubricants on the compaction properties of granulated and non-granulated cross-linked high amylose starch. Chem Pharm Bull.2002;50:1155–1162. [CrossRef]
- [21]Sadeghi F, Mosaffa F, Garekani HA. Effect of particle size , compaction force and presence of aerosil 200 on the properties of matrices prepared from physical mixture of propranolol hydrochloride and Eudragit RSor RL. Iran J Basic Med Sci.2007;10:197–205.
- [22]Sun CC. Decoding powder tabletability: roles of particle adhesion and plasticity. J Adhes Sci Technol.2011;25:483–499. [CrossRef]
- [23]Joiris E, Di Martino P, Berneron C, Guyot-Hermann A, Guyot J. Compression behavior of orthorhombic paracetamol. Pharm Res.1998;15:1122–1130.[CrossRef]
- [24]Upadhyay P, Khomane KS, Kumar L, Bansal AK. Relationship between crystal structure and mechanical properties of ranitidine hydrochloride polymorphs. CrystEngComm.2013;15:3959–3964. [CrossRef]
- [25]Osei-Yeboah F, Chang S, Sun CC. A critical examination of the phenomenon of bonding area -bonding strength interplay in powder tableting. Pharm Res.2016;33:1126–1132. [CrossRef]
- [26]Rojas J, Kumar V. Comparative evaluation of silicified microcrystalline cellulose II as a direct compression vehicle. Int J Pharm.2011;416:120–128. [CrossRef]
- [27]Krishna GR, Shi L, Bag PP, Sun CC, Reddy CM. Correlation among crystal structure, mechanical behavior, and tabletability in the co-crystals of vanillin isomers. Cryst Growth Des.2015;15:1827–1832. [CrossRef]
- [28]Yadav JA, Khomane KS, Modi SR, Ugale B, Yadav RN, Nagaraja CM, Kumar N, Bansal AK. Correlating single crystal structure, nanomechanical, and bulk compaction behavior of febuxostat polymorphs. Mol Pharm. 2017; 14: 866–874. [CrossRef]
- [29]Allen L, Popovich N, Ansel H. Powders and granules. In: Allen L, Popovich N, Ansel H.(Eds).Ansel’s Pharmaceutical DosageForms and Drug DeliverySystems. Lippincott Williams & Wilkins, New York, 2005, pp. 186–203.
- [30]Alebiowu G. Studies on the tableting properties of Sorghum Bicolor Linn (Poaceae) starch I: Evaluation of binder types and concentrations on the properties of sorghum starch granulations. Discov Innov.2001;13:73–77.[CrossRef]
- [31]Szumilo M, Belniak P, Swiader K, Holody E, Poleszak E. Assessment of physical properties of granules with paracetamol and caffeine. Saudi Pharm J. 2017; 25: 900–905. [CrossRef]
- [32]Heckel RW. Density-pressure relationships in powder compaction. Trans Metall Soc AIME.1961;221:671–675.
- [33]Kawakita K, Lüdde KH.Some considerations on powder compression equations. Powder Technol.1971;4:61–68.[CrossRef]
- [34]Walker EE. The properties of powders. Part VI. The compressibility of powders. Trans Faraday Soc.1923;19:73–82. [CrossRef]
- [35]Sonnergaard JM. A critical evaluation of the Heckel equation. Int J Pharm.1999;193:63–71.[CrossRef]
- [36]Fell J, Newton J. Determination of tablet strength by the diametral-compression test. J Pharm Sci.1970;59:688–691.[CrossRef]
- [37]Adeoye O, Alebiowu G. Evaluation of co-processed disintegrants produced from tapioca starch and mannitol in orally disintegrating paracetamol tablets. Acta Pol Pharm ñ Drug Res. 2014; 71(5): 803–811.
- [38]Adjei FK, Osei YA, Kuntworbe N, Ofori-kwakye K. Evaluation of the disintegrant properties of native starches of five new cassava varieties in paracetamol tablet formulations. J Pharm 2017; 2017: 1–9. [CrossRef]
- [39]El-Barghouthi M, Eftaiha A, Rashid I, Al-Remawi M, Badwan A. A novel superdisintegrating agent made from physically modified chitosan with silicon dioxide. Drug Dev Ind Pharm. 2008; 34: 373–383. [CrossRef]