Impact of moisture and magnesium stearate functionality on manufacturability of wet granulated metformin tablets

References

• Bolhuis G, Lerk C, Zijlstra H, Boer DA. Film formation by magnesium stearate during mixing and its effect on tabletting. Pharm Weekbl 1975;110:317–325
   Google Scholar
• Iranloye TA, Parrott EL. Effects of compression force, particle size, and lubricants on dissolution rate. J Pharm Sci 1978;67:535–539
   PubMed Web of Science ®Google Scholar
• Bolhuis GK, Hölzer AW. Lubrication issues in direct compaction. In: Çelik M, ed. Pharmaceutical powder compaction technology. 2nd ed. London: Informa Healthcare; 2011:205–234
   Google Scholar
• Desai DS, Rubitski BA, Varia SA, Newman AW. Physical interactions of magnesium stearate with starch-derived disintegrants and their effects on capsule and tablet dissolution. Int J Pharm 1993;91:217–226
   Web of Science ®Google Scholar
• Zuurman K, Van der Voort Maarschalk K, Bolhuis G. Effect of magnesium stearate on bonding and porosity expansion of tablets produced from materials with different consolidation properties. Int J Pharm 1999;179:107–115
   PubMed Web of Science ®Google Scholar
• Gupta A, Hamad ML, Tawakkul M, et al Difference in the lubrication efficiency of bovine and vegetable-derived magnesium stearate during tabletting. AAPS PharmSciTech 2009;10:500–504
   PubMed Web of Science ®Google Scholar
• Barra J, Somma R. Influence of the physicochemical variability of magnesium stearate on its lubricant properties: possible solutions. Drug Dev Ind Pharm 1996;22:1105–1120
   Web of Science ®Google Scholar
• Ertel K, Carstensen J. Chemical, physical, and lubricant properties of magnesium stearate. J Pharm Sci 1988;77:625–629
   PubMed Web of Science ®Google Scholar
• Haware RV, Shivagari R, Johnson PR, et al Application of multivariate methods to evaluate the functionality of bovine- and vegetable-derived magnesium stearate. J Pharm Sci 2014;103:1466–1477
   PubMed Web of Science ®Google Scholar
• Dansereau R, Peck GE. The effect of the variability in the physical and chemical properties of magnesium stearate on the properties of compressed tablets. Drug Dev Ind Pharm 1987;13:975–999
   Web of Science ®Google Scholar
• Rao KP, Chawla G, Kaushal AM, Bansal AK. Impact of solid-state properties on lubrication efficacy of magnesium stearate. Pharm Dev Technol 2005;10:423–437
   PubMed Web of Science ®Google Scholar
• Leinonen UI, Jalonen HU, Vihervaara PA, Laine ESU. Physical and lubrication properties of magnesium stearate. J Pharm Sci 1992;81:1194–1198
   PubMed Web of Science ®Google Scholar
• Pitt K, Newton J, Stanley P. Tensile fracture of doubly-convex cylindrical discs under diametral loading. J Mater Sci 1988;23:2723–2728
   Web of Science ®Google Scholar
• Pitt KG, Heasley MG. Determination of the tensile strength of elongated tablets. Powder Technol 2013;238:169–175
   Web of Science ®Google Scholar
• Denny PJ. Compaction equations: a comparison of the Heckel and Kawakita equations. Powder Technol 2002;127:162–172
   Web of Science ®Google Scholar
• Desai D, Wong B, Huang Y, et al Influence of dissolution media pH and USP1 basket speed on erosion and disintegration characteristics of immediate release metformin hydrochloride tablets. Pharm Dev Technol 2015;20:540–545
   PubMed Web of Science ®Google Scholar
• Jones TM. The influence of physical characteristics of excipients on the design and preparation of tablets and capsules. Pharm Ind 1977;39:469–476
   Google Scholar
• Wada Y, Matsubara T. Pseudopolymorphism and lubricating properties of magnesium stearate. Powder Technol 1994;78:109–114
   Web of Science ®Google Scholar
• Miller T, York P. Physical and chemical characteristics of some high purity magnesium stearate and palmitate powders. Int J Pharm 1985;23:55–67
   Web of Science ®Google Scholar
• Colombo I, Carli F. Comparative evaluation of structure and micromeritics properties of magnesium stearate. Farmaco Prat 1984;39:329–341
   PubMedGoogle Scholar
• Akande OF, Ford JL, Rowe PH, Rubinstein MH. The effects of lag‐time and dwell‐time on the compaction properties of 1:1 paracetamol/microcrystalline cellulose tablets prepared by pre‐compression and main compression. J Pharm Pharmacol 1998;50:19–28
   PubMed Web of Science ®Google Scholar
• Narang AS, Rao VM, Guo H, et al Effect of force feeder on tablet strength during compression. Int J Pharm 2010;401:7–15
   PubMed Web of Science ®Google Scholar
• Mehrotra A, Llusa M, Faqih A, et al Influence of shear intensity and total shear on properties of blends and tablets of lactose and cellulose lubricated with magnesium stearate. Int J Pharm 2007;336:284–291
   PubMed Web of Science ®Google Scholar
• Garr JSM, Rubinstein MH. The influence of moisture content on the consolidation and compaction properties of paracetamol. Int J Pharm 1992;81:187–192
   Web of Science ®Google Scholar
• Nokhodchi A, Rubinstein M, Larhrib H, Guyot J. The effect of moisture on the properties of ibuprofen tablets. Int J Pharm 1995;118:191–197
   Web of Science ®Google Scholar
• Teng C, Alkan M, Creves N. The effect of adsorbed water on compaction properties and the dissolution of quinacrine hydrochloride from compacted matrices of soy protein. Drug Dev Ind Pharm 1986;12:2325–2336
   Web of Science ®Google Scholar
• Khan KA, Musikabhumma P, Warr JP. The effect of moisture content of microcrystalline cellulose on the compressional properties of some formulations. Drug Dev Ind Pharm 1981;7:525–538
   Web of Science ®Google Scholar
• Jaffe J, Foss NE. Compression of crystalline substances. J Am Pharm Assoc Am Pharm Assoc 1959;48:26–29
   PubMedGoogle Scholar
• Coelho M, Harnby N. Moisture bonding in powders. Powder Technol 1978;20:201–205
   Web of Science ®Google Scholar
• Malamataris S, Karidas T. Effect of particle size and sorbed moisture on the tensile strength of some tableted hydroxypropyl methylcellulose (HPMC) polymers. Int J Pharm 1994;104:115–123
   Web of Science ®Google Scholar
• Down G, McMullen J. The effect of interparticulate friction and moisture on the crushing strength of sodium chloride compacts. Powder Technol 1985;42:169–174
   Web of Science ®Google Scholar
• Nokhodchi A. Effect of moisture on compaction and compression. Pharm Tech 2005;6:46–66
   Google Scholar
• Armstrong NA, Patel A, Jones TM. The compressional properties of dextrose monohydrate and anhydrous dextrose of varying water contents. Drug Dev Ind Pharm 1986;12:1885–1901
   Web of Science ®Google Scholar
• Boutell S, Newton J, Bloor J, Hayes G. The influence of liquid binder on the liquid mobility and preparation of spherical granules by the process of extrusion/spheronization. Int J Pharm 2002;238:61–76
   PubMed Web of Science ®Google Scholar
• Itiola O, Pilpel N. Formulation effects on the mechanical properties of metronidazole tablets. J Pharm Pharmacol 1991;43:145–147
   PubMed Web of Science ®Google Scholar
• Armstrong N, Griffiths R. The effects of moisture on the flow properties and compression of phenacetin, paracetamol and dextrose monohydrate. Pharm Acta Helv 1970;45:692–700
   PubMedGoogle Scholar
• Chowhan Z. Role of binders in moisture‐induced hardness increase in compressed tablets and its effect on in vitro disintegration and dissolution. J Pharm Sci 1980;69:1–4
   PubMed Web of Science ®Google Scholar
• Desai D, Kothari S, Huang M. Solid-state interaction of stearic acid with povidone and its effect on dissolution stability of capsules. Int J Pharm 2008;354:77–81
   PubMed Web of Science ®Google Scholar