Assessment of Tribo-charging and Continuous Feeding Performance of Direct Compression Grades of Isomalt and Mannitol Powders
Tóm tắt
Tribo-charging is often a root cause of mass flow deviations and powder adhesion during continuous feeding. Thus, it may critically impact product quality. In this study, we characterized the volumetric (split- and pre-blend) feeding behavior and process-induced charge of two direct compression grades of polyols, galenIQ™ 721 (G721) for isomalt and PEARLITOL® 200SD (P200SD) for mannitol, under different processing conditions. The feeding mass flow range and variability, hopper end fill level, and powder adhesion were profiled. The feeding-induced tribo-charging was measured using a Faraday cup. Both materials were comprehensively characterized for relevant powder properties, and their tribo-charging was investigated for its dependence on particle size and relative humidity. During split-feeding experiments, G721 showed a comparable feeding performance to P200SD with lower tribo-charging and adhesion to the screw outlet of the feeder. Depending on the processing condition, the charge density of G721 ranged from -0.01 up to -0.39 nC/g, and for P200SD from -3.19 up to -5.99 nC/g. Rather than differences in the particle size distribution of the two materials, their distinct surface and structural characteristics were found as the main factors affecting their tribo-charging. The good feeding performance of both polyol grades was also maintained during pre-blend feeding, where reduced tribo-charging and adhesion propensity was observed for P200SD (decreasing from -5.27 to -0.17 nC/g under the same feeding settings). Here, it is proposed that the mitigation of tribo-charging occurs due to a particle size-driven mechanism.
Tài liệu tham khảo
Bolhuis GK, Rexwinkel EG, Zuurman K. Polyols as filler-binders for disintegrating tablets prepared by direct compaction. Drug Dev Ind Pharm. 2009;35(6):671–7.
Ohrem HL, Schornick E, Kalivoda A, Ognibene R. Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms? Pharm Dev Technol. 2014;19(3):257–62.
Bolhuis GK, Engelhart JJP, Eissens AC. Compaction properties of isomalt. Eur J Pharm Biopharm. 2009;72:621–5.
Zarbock SD, Magnuson B, Hoskins L, Record KE, Smith KM. Lactose: The hidden culprit in medication intolerance? Orthopedics. 2007;30(8):615–7.
Bharate SS, Bharate SB, Bajaj AN. Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review. J Excipients Food Chem. 2010;1(3):3–26.
Karttunen A-P, Poms J, Sacher S, Sparén A, Samblás CR, Fransson M, et al. Robustness of a continuous direct compression line against disturbances in feeding. Int J Pharm. 2020;574: 118882.
Lakio S, Ervasti T, Tajarobi P, Wikström H, Fransson M, Karttunen A-P, et al. Provoking an end-to-end continuous direct compression line with raw materials prone to segregation. Eur J Pharm Sci. 2017;109:514–24.
Karttunen A, Wikström H, Tajarobi P, Fransson M, Sparén A, Marucci M, et al. Comparison between integrated continuous direct compression line and batch processing – the effect of raw material properties. Eur J Pharm Sci. 2019;133:40–53.
Rescaglio A, De Smet F, Aerts L, Lumay G. Tribo-electrification of pharmaceutical powder blends. Part Sci Technol. 2019;1–8
Barrios-Vazquez SC, Villafuerte-Robles L. Functionality of galenIQ 721 as excipient for direct compression tablets. J Appl Pharm Sci. 2013;3(4):8–19.
Muzíková J, Pavlasová V. Energy evaluation of the compaction process of directly compressible isomalt. Ces Slov Farm. 2011;60(1):11–6.
Govedarica B, Ilić I, Šibanc R, Dreu R, Srčič S. The use of single particle mechanical properties for predicting the compressibility of pharmaceutical materials. Powder Technol. 2012;225:43–51.
Rowe RC, Sheskey PJ, Quinn ME. Handbook of pharmaceutical excipients. 6th editio. Pharmaceutical Press; 2009
Mukherjee R, Sansare S, Nagarajan V, Chaudhuri B. Discrete element modeling (DEM) based investigation of tribocharging in the pharmaceutical powders during hopper discharge. Int J Pharm. 2021;596: 120284.
Engisch WE, Muzzio FJ. Loss-in-weight feeding trials case study: pharmaceutical formulation. J Pharm Innov. 2014;10:56–75.
Gold G, Palermo BT. Hopper flow electrostatics of tableting material I Instrumentation and acetaminophen formulations. J Pharm Sci. 1965;54(2):310–2.
Muehlenfeld C, Thommes M. Small-scale twin-screw extrusion - evaluation of continuous split feeding. J Pharm Pharmacol. 2014;66:1667–76.
Hsiao WK, Hörmann TR, Toson P, Paudel A, Ghiotti P, Stauffer F, et al. Feeding of particle-based materials in continuous solid dosage manufacturing: a material science perspective. Drug Discov Today. 2020;25(4):800–6.
Bostijn N, Dhondt J, Ryckaert A, Szabó E, Dhondt W, Van Snick B, et al. A multivariate approach to predict the volumetric and gravimetric feeding behavior of a low feed rate feeder based on raw material properties. Int J Pharm. 2019;557:342–53.
Stauffer F, Vanhoorne V, Pilcer G, Chavez PF, Schubert MA, Vervaet C, et al. Managing active pharmaceutical ingredient raw material variability during twin-screw blend feeding. Eur J Pharm Biopharm. 2019;135:49–60.
Bekaert B, Penne L, Grymonpre W, Van Snick B, Dhondt J, Boeckx J, et al. 2021 Determination of a quantitative relationship between material properties, process settings and screw feeding behavior via multivariate data-analysis. Int J Pharm. 602(120603)
Beretta M, Hörmann TR, Hainz P, Hsiao W-K, Paudel A 2020 Investigation into powder tribo-charging of pharmaceuticals. Part I: process-induced charge via twin-screw feeding. Int J Pharm. 591(120014)
Allenspach C, Timmins P, Lumay G, Holman J, Minko T. Loss-in-weight feeding, powder flow and electrostatic evaluation for direct compression hydroxypropyl methylcellulose (HPMC) to support continuous manufacturing. Int J Pharm. 2021;596: 120259.
Karner S, Urbanetz NA. Arising of electrostatic charge in the mixing process and its influencing factors. Powder Technol. 2012;226:261–8.
Pu YU, Mazumder M, Cooney C. Effects of electrostatic charging on pharmaceutical powder blending homogeneity. J Pharm Sci. 2009;98:2412–21.
Naik S, Mukherjee R, Chaudhuri B. Triboelectrification: a review of experimental and mechanistic modeling approaches with a special focus on pharmaceutical powders. Int J Pharm. 2016;510:375–85.
Kaialy W. A review of factors affecting electrostatic charging of pharmaceuticals and adhesive mixtures for inhalation. Int J Pharm. 2016;503:262–76.
Beretta M, Hörmann TR, Hainz P, Hsiao WK, Paudel A. Investigation into powder tribo–charging of pharmaceuticals. Part II: Sensitivity to relative humidity. Int J Pharm. 2020;591(120015)
Paul S, Chang SY, Dun J, Sun WJ, Wang K, Tajarobi P, et al. Comparative analyses of flow and compaction properties of diverse mannitol and lactose grades. Int J Pharm. 2018;546:39–49.
Greenspan L. Humidity fixed points of binary saturated aqueous solutions. J Res Natl Bur Stand - A Phys Chem. 1977;81(1):89–96.
Hörmann-Kincses TR, Beretta M, Kruisz J, Stauffer F, Birk G, Piccione PM, et al. Predicting powder feedability: a workflow for assessing the risk of flow stagnation and defining the operating space for different powder-feeder combinations. Int J Pharm. 2022;629(122364)
Li T, Scicolone JV, Sanchez E, Muzzio FJ. Identifying a loss-in-weight feeder design space based on performance and material properties. J Pharm Innov. 2020;15(3):482–95.
Wang Y, Li T, Muzzio FJ, Glasser BJ. Predicting feeder performance based on material flow properties. Powder Technol. 2017;308:135–48.
Kastner J, Heinzl C. X-ray tomography. In: Handbook of Advanced Non-Destructive Evaluation. Springer; 2018. p. 1–72.
Barrett EP, Joyner LG. Halenda PP The determination of volume and area distributions in porous substances I. Computations from nitrogen isotherms. J Am Chem Soc. 1951;73:373–80.
Washburn EW. The dynamics of capillary flow. Phys Rev. 1921;17(3):273–83.
Dorris GM, Gray DG. Adsorption of n-alkanes at zero surface coverage on cellulose paper and wood fibers. J Colloid Interface Sci. 1980;77(2):353–62.
Van Oss CJ, Chaudhury MK, Good RJ. Interfacial Lifshitz-van der Waals and polar interactions in macroscopic systems. Chem Rev. 1988;88:927–41.
Jallo LJ, Dave RN. Explaining electrostatic charging and flow of surface-modified acetaminophen powders as a function of relative humidity through surface energetics. J Pharm Sci. 2015;104(7):2225–32.
Santos O, Nylander T, Rosmaninho R, Rizzo G, Yiantsios S, Andritsos N, et al. Modified stainless steel surfaces targeted to reduce fouling - surface characterization. J Food Eng. 2004;64:63–79.
Santos B, Carmo F, Schlindwein W, Muirhead G, Rodrigues C, Cabral L, et al. Pharmaceutical excipients properties and screw feeder performance in continuous processing lines: a quality by design (QbD) approach. Drug Dev Ind Pharm. 2018;44:2089–97.
Vehring R. Pharmaceutical particle engineering via spray drying. Pharm Res. 2008;25(5):999–1022.
Carr RL. Evaluating Flow Properties of Solids. Chem Eng. 1965;72:163–8.
Li XH, Zhao LJ, Ruan KP, Feng Y, Xu DS, Ruan KF. The application of factor analysis to evaluate deforming behaviors of directly compressed powders. Powder Technol. 2013;247:47–54.
Sarkar S, Cho J, Chaudhuri B. Mechanisms of electrostatic charge reduction of granular media with additives on different surfaces. Chem Eng Process. 2012;62:168–75.
Mukherjee R, Gupta V, Naik S, Sarkar S, Sharma V, Peri P, et al. Effects of particle size on the triboelectrification phenomenon in pharmaceutical excipients: experiments and multi-scale modeling. Asian J Pharm Sci. 2016;11:603–17.
Zheng XJ, Huang N, Zhou YH. Laboratory measurement of electrification of wind-blown sands and simulation of its effect on sand saltation movement. J Geophys Res Atmos. 2003;108(D10):4322.
Samiei L, Kelly K, Taylor L, Forbes B, Collins E, Rowland M. The influence of electrostatic properties on the punch sticking propensity of pharmaceutical blends. Powder Technol. 2017;305:509–17.
Zhou H, Götzinger M, Peukert W. The influence of particle charge and roughness on particle-substrate adhesion. Powder Technol. 2003;135–136:82–91.
Bunker MJ, Davies MC, James MB, Roberts CJ. Direct observation of single particle electrostatic charging by atomic force microscopy. Pharm Res. 2007;24(6):1165–9.
McCarty LS, Whitesides GM. Electrostatic charging due to separation of ions at interfaces: contact electrification of ionic electrets. Angew Chem Int Ed. 2008;47:2188–207.
Alan BO, Barisik M, Ozcelik HG. Roughness effects on the surface charge properties of silica nanoparticles. J Phys Chem C. 2020;124(13):7274–86.
Schella A, Herminghaus S, Schröter M. Influence of humidity on tribo-electric charging and segregation in shaken granular media. Soft Matter. 2017;13:394–401.
Zellnitz S, Pinto JT, Brunsteiner M, Schroettner H, Khinast J, Paudel A. Tribo-charging behaviour of inhalable mannitol blends with salbutamol sulphate. Pharm Res. 2019;36:80.
Pinto JT, Wutscher T, Stankovic-Brandl M, Zellnitz S, Biserni S, Mercandelli A, et al. Evaluation of the physico-mechanical properties and electrostatic charging behavior of different capsule types for inhalation under distinct environmental conditions. AAPS PharmSciTech. 2020;21(128)
Forward KM, Lacks DJ, Sankaran RM. Charge segregation depends on particle size in triboelectrically charged granular materials. Phys Rev Lett. 2009;102:028001
Waitukaitis SR, Lee V, Pierson JM, Forman SL, Jaeger HM. Size-dependent same-material tribocharging in insulating grains. Phys Rev Lett. 2014;112(218001)