Skip to main content
Log in

Application of thermal effusivity as a process analytical technology tool for monitoring and control of the roller compaction process

  • Published:
AAPS PharmSciTech Aims and scope Submit manuscript

Abstract

The aim of this study was to examine the relationship between physical characteristics of compacted ribbons and their thermal effusivity in an attempt to evaluate the feasibility of using effusivity for in-process monitoring of roller compaction. In this study, thermal effusivity, solid fraction, tensile strength, and Young's modulus of ribbons of microcrystal-line cellulose (MCC), anhydrous lactose, and placebo (PBO) formulations containing various ratios of MCC to anhydrous lactose (75∶20, 55∶40, 40∶55, and 20∶75) were determined at various compaction pressures (25–150 bars). The effusivity-square root of solid fraction relationship was linear for MCC and all the PBO formulations but was a second-order polynomial function for lactose. This could be due to the predominant deformation of lactose by brittle fracture, which might have significantly increased the number and size of contact points between particles, causing a change in thermal conductivity along with a density change. The effusivitytensile strength and effusivity-Young's modulus relationships were best described by logarithmic functions for MCC but were linear for lactose up to a compaction pressure of 65 bars. There were similar relationships for effusivity with tensile strength and Young's modulus for all PBO formulations except PBO IV, which might have been due to the deformation of lactose, the largest component in this formulation. Strong correlations between effusivity and physical properties of ribbons were established. Although these correlations were formulation-dependent, they demonstrate the possibility of using effusivity as a tool in monitoring roller compaction.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

  1. Shenoy P. Process analytical technology.Pharm Times. 2004; 36:37–38.

    Google Scholar 

  2. Davis TD, Morris KR, Huang HP, et al. In situ monitoring of wet granulation using online x-ray powder diffraction.Pharm Res. 2003;20:1851–1857.

    Article  CAS  Google Scholar 

  3. Balboni ML. Process analytical technology: concepts and principles.Pharm Technol. 2003;27:54–66.

    Google Scholar 

  4. US Food and Drug Administration.PAT—A Framework for Innovative Pharmaceutical Development. Manufacturing, and Quality Assurance, Guidance for Industry. Washington, DC: US Food and Drug Administration, Center for Drug Evaluation and Research; 2004.

  5. Miller RW. Roller compaction technology. In Parikh DM, ed.Handbook of Pharmaceutical Granulation Technology. New York, NY: Marcel Dekker; 1997:99–149.

    Google Scholar 

  6. Adeyeye MC. Roller compaction and milling pharmaceutical unit processes: part I.Am Pharm Rev. 2000;3:37–42.

    CAS  Google Scholar 

  7. Falzone AM, Peck GE, McCabe GP. Effects of changes in roller compactor parameters on granulations produced by compaction.Drug Dev Ind Pharm. 1992;18:469–489.

    Article  CAS  Google Scholar 

  8. Jerome E, Delacourte A, Leterme P, Guyot JC. The measurement of resulting forces on a roller compactor.Drug Dev Ind Pharm. 1991;17:1571–1591.

    Article  Google Scholar 

  9. Gupta A, Peck GE, Miller RW, Morris KR. Nondestructive measurements of the compact strength and the particle-size distribution after milling of roller compacted powders by near-infrared spectroscopy.J Pharm Sci., 2004;93:1047–1053.

    Article  CAS  Google Scholar 

  10. Hakanen A, Laine E. Accoustic characterization of a microcrystalline cellulose powder during and after its compression.Drug Dev Ind Pharm. 1995;21:1573–1582.

    Article  CAS  Google Scholar 

  11. Gupta A, Peck GE, Miller RW, Morris KR. Real-time near-infrared monitoring of content uniformity, moisture content, compact density, tensile strength, and Young's modulus of roller compacted powder blends.J Pharm Sci., 2005;94:1589–1597.

    Article  CAS  Google Scholar 

  12. Mathews L, Chandler C, Dipali S, et al. Monitoring blend uniformity with effusivity.Pharm Technol., 2002;26:80–84.

    CAS  Google Scholar 

  13. Roy Y, Closs S, Mathis N, Nieves E. Thermal effusivity as a process analytical technology to optimize, monitor and control fluid-bed drying.Pharm Technol., 2004;28:21–28.

    Google Scholar 

  14. Roy Y, Mathis N, Closs S, et al. Online thermal effusivity monitoring: a promising technique for determining when to conclude blending of magnesium stearate.Tablets Capsules. 2005;3:38–47.

    Google Scholar 

  15. Zinchuk AV, Mullarney MP, Hancock BC. Simulation of roller compaction using a laboratory scale compaction simulator.Int J Pharm. 2004;269:403–415.

    Article  CAS  Google Scholar 

  16. Shapiro M, Dudko V, Royzen V, et al. Characterization of powder beds by thermal conductivity: effect of gas pressure on the thermal resistance of particle contact points.Part Part Syst Char., 2004;21:268–275.

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Mohamed K. Ghorab.

Additional information

Published: March 23, 2007

Rights and permissions

Reprints and permissions

About this article

Cite this article

Ghorab, M.K., Chatlapalli, R., Hasan, S. et al. Application of thermal effusivity as a process analytical technology tool for monitoring and control of the roller compaction process. AAPS PharmSciTech 8, 23 (2007). https://doi.org/10.1208/pt0801023

Download citation

  • Received:

  • Accepted:

  • DOI: https://doi.org/10.1208/pt0801023

Keywords

Navigation