Abstract
The aim of this study was to investigate the lubrication potential of 2 grades of magnesium stearate (MS) blended with a mix of dicalcium phosphate dihydrate and microcrystalline cellulose. Force-displacement, force-time, and ejection profiles were generated using an instrumented rotary tablet press, and the effect of MS mixing time (10, 20, and 30 minutes) and tableting speed (10.7, 13.8, and 17.5 rpm) was investigated. The packing index (PI), frictional index (FI), and packing energy (PE) derived from the force-displacement profiles showed that MS sample I performed better than sample II. At higher lubricant mixing times, the values of PI were observed to increase, and values of FI and PE were observed to decrease for both MS samples. Lower values of area under the curve (AUC) calculated from force-time compression profiles also showed sample I to be superior to sample II in lubrication potential. For both the samples, the values of AUC were observed to decrease with higher lubricant mixing times. Tapping volumetry that simulates the initial particle rear-rangement gave values of parameter a and Cmax that were higher for sample I than sample II and also increased with lubricant mixing time. The superior lubrication potential of sample I was also established by the lower values of peak ejection force encountered in the ejection profile. Lower ejection forces were also found to result from higher tableting speeds and longer lubricant mixing times. The difference in lubrication efficacy of the 2 samples could be attributed to differences in their solid-state properties, such as particle size, specific surface area, and d-spacing.
Keywords: Magnesium stearate, lubrication efficiency, force-displacement profile, force-time profile, particle rear-rangement, ejection profile
Full Text
The Full Text of this article is available as a PDF (191.4 KB).
Footnotes
Themed Issue: Process Analytical Technology
Guest Editor — Ajaz Hussain
References
- 1.Gohel MC, Jogani PD. Functionality testing of a multifunctional directly compressible adjuvant containing lactose, polyvinylpyrrolidone, and croscarmellose sodium. Pharm Technol. 2002;26:64–82. [Google Scholar]
- 2.Banker GS. Tablets. In: Lachman L, Liberman HA, Kanig JL, editors. The Theory and Practice of Industrial Pharmacy. 3rd ed. Bombay, India: Varghese; 1976. pp. 293–329. [Google Scholar]
- 3.Matsuda Y, Minamida Y, Hayashi SI. Comparative evaluation of tablet lubricants: effect of application method on tablet hardness and ejectability after compression. J Pharm Sci. 1976;65:1155–1160. doi: 10.1002/jps.2600650807. [DOI] [PubMed] [Google Scholar]
- 4.Vitkova M, Chalabala M. The use of some hydrophobic substances in tablet technology. Acta Pharm Hung. 1998;68:336–344. [PubMed] [Google Scholar]
- 5.Iranloye T, Parrott E. Effects of compression force, particle size, and lubricants on dissolution rate. J Pharm Sci. 1978;67:535–539. doi: 10.1002/jps.2600670424. [DOI] [PubMed] [Google Scholar]
- 6.Shah AC, Mlodozeniec ML. Mechanism of surface lubrication: influence of duration of lubricant-excipient mixing on processing characteristics of powders and properties of compressed tablets. J Pharm Sci. 1977;66:1377–1378. doi: 10.1002/jps.2600661006. [DOI] [PubMed] [Google Scholar]
- 7.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. doi: 10.1081/pdt-54462. [DOI] [PubMed] [Google Scholar]
- 8.Heda PK, Muteba K, Augsburger LL. Comparison of the formulation requirements of dosator and dosing disc automatic capsule filling machines.AAPS PharmSci [serial online]. 2002;4:e17. [DOI] [PMC free article] [PubMed]
- 9.Marshall K. Compression and consolidation of powdered solids. In: Lachman L, Lieberman HA, Kanig JL, editors. The Theory and Practice of Industrial Pharmacy. 3rd ed. Bombay, India: Varghese; 1976. pp. 66–99. [Google Scholar]
- 10.Matz C, Bauer-Brandl A, Rigassi T, Schubert R, Becker D. On the accuracy of a new displacement instrumentation for rotary tablet presses. Drug Dev Ind Pharm. 1999;25:117–130. doi: 10.1081/DDC-100102152. [DOI] [PubMed] [Google Scholar]
- 11.Antikainen O, Yliruusi J. Determining the compression behavior of pharmaceutical powders from the force-distance compression profile. Int J Pharm. 2003;252:253–261. doi: 10.1016/S0378-5173(02)00665-8. [DOI] [PubMed] [Google Scholar]
- 12.Oates RJ, Mitchell AG. Calculation of punch displacement and work of powder compaction on a rotary tablet press. J Pharm Pharmacol. 1989;41:517–523. doi: 10.1111/j.2042-7158.1989.tb06518.x. [DOI] [PubMed] [Google Scholar]
- 13.Viana M, Ribet J, Rodriguez F, Chulia D. Powder functionality test: a methodology for rheological and mechanical characterization. Pharm Dev Technol. 2005;10:327–338. doi: 10.1081/PDT-200054481. [DOI] [PubMed] [Google Scholar]
- 14.York P. Particle slippage and rearrangement during compression of pharmaceutical powders. J Pharm Pharmacol. 1978;30:6–10. doi: 10.1111/j.2042-7158.1978.tb13144.x. [DOI] [PubMed] [Google Scholar]
- 15.Sheikh-Salem M, Fell JT. The influence of initial packing on the compression of powders. J Pharm Pharmacol. 1981;33:491–494. doi: 10.1111/j.2042-7158.1981.tb13846.x. [DOI] [PubMed] [Google Scholar]
- 16.Bolhuis GK, Lerk CF, Broersma P. Mixing action and evaluation of tablet lubricants in direct compression. Drug Dev Ind Pharm. 1980;6:15–33. doi: 10.3109/03639048009051924. [DOI] [Google Scholar]
- 17.Katikaneni PR, Upadrashta SM, Rowlings CE, Neau SH, Hileman GA. Consolidation of ethylcellulose: effect of particle size, press speed, and lubricants. Int J Pharm. 1995;117:13–21. doi: 10.1016/0378-5173(94)00288-G. [DOI] [Google Scholar]
- 18.Schmidt PC, Leitritz M. Compression force/time-profiles of microcrystalline cellulose, dicalcium phosphate dihydrate and their binary mixtures—a critical consideration of experimental parameters. Eur J Pharm Biopharm. 1997;44:303–313. doi: 10.1016/S0939-6411(97)00129-X. [DOI] [Google Scholar]
- 19.Leitritz M, Krumme M, Schmidt PC. Force-time curves of a rotary tablet press. Interpretation of the compressibility of a modified starch containing various amounts of moisture. J Pharm Pharmacol. 1996;48:456–462. doi: 10.1111/j.2042-7158.1996.tb05954.x. [DOI] [PubMed] [Google Scholar]
- 20.Kawakita K, Lüdde KH. Some considerations on powder compression equations. Powder Technol. 1971;4:61–68. doi: 10.1016/0032-5910(71)80001-3. [DOI] [Google Scholar]
- 21.Kawakita K, Hattori I, Kishigami M. Characteristic constants in Kawakita’s powder compression equation. J Powder Bulk Solids Technol. 1977;1:3–8. [Google Scholar]
- 22.Kikuta J, Kitamori N. Evaluation of the die wall friction tablet ejection. Powder Technol. 1983;35:195–200. doi: 10.1016/0032-5910(83)87009-0. [DOI] [Google Scholar]
- 23.Takeuchi H, Nagira S, Yamamoto H, Kawashima Y. Die wall pressure measurement for evaluation of compaction property of pharmaceutical materials. Int J Pharm. 2004;274:131–138. doi: 10.1016/j.ijpharm.2004.01.008. [DOI] [PubMed] [Google Scholar]
- 24.Rees JE, Rue PJ. Time-dependent deformation of some direct compression excipients. J Pharm Pharmacol. 1978;30:601–607. doi: 10.1111/j.2042-7158.1978.tb13340.x. [DOI] [PubMed] [Google Scholar]
- 25.Munoz-Ruiz A, Wihervaara M, Hakkinen M, Juslin M, Paronen P. Frictional work in double-sided tablet compression. J Pharm Sci. 1997;86:481–486. doi: 10.1021/js960287r. [DOI] [PubMed] [Google Scholar]