Skip to main content
SpringerLink
Log in

Evaluation of a Dry Coating Technology as a Substitute for Roller Compaction for Dry Agglomeration Applications in the Pharmaceutical Industry

  • Original Article
  • Published:
Journal of Pharmaceutical Innovation Aims and scope Submit manuscript

Abstract

Purpose

A dry coating technology has been evaluated as a dry agglomeration technique for a typical pharmaceutical formulation. Its efficiency was compared with that of the more commonly used roller compaction dry granulation.

Methods

A commercially available system was selected as a representative technology. The selection was based on batch size, processing time, unit size, vendor support, preventive maintenance requirements, development stage, and maturity for pharmaceutical industry requirements. The comparison targets the behavior of the resulting materials in terms of flowability, compressibility, mixing efficiency, and prevention of segregation. Particle size distribution, bulk density, scanning electron microscopy, FT4 powder rheometer, and hardness were used for the characterization of the powders. A design of experiment was used to evaluate the impact of the dry coating equipment operating parameters (rotor speed and processing time) as well as the impact of formulation (grade of microcrystalline cellulose and ratio between dibasic calcium phosphate and lactose).

Results

The tested dry coating technology shows (1) an improved compressibility, (2) that the powders are homogenous, and (3) that they do not have a tendency to segregate in downstream process steps and during handling and storage. The impact of the rotor speed is proven statistically not significant, but it seems that a lower rotor speed might lead to less attrition and better flow properties. Processing time does not seem to have an impact for the range of processing times evaluated. Compared to roller compaction, the main advantages of the tested technology are the shape and surface enhancement and the absence of work hardening.

Conclusions

This work has shown that the blends produced by the targeted dry coating equipment has equal or better results than the powders processed by roller compaction for all the critical quality attributes that were evaluated.

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

Access this article

Log in via an institution

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

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7
Fig. 8
Fig. 9
Fig. 10
Fig. 11
Fig. 12
Fig. 13
Fig. 14
Fig. 15
Fig. 16
Fig. 17
Fig. 18
Fig. 19
Fig. 20
Fig. 21
Fig. 22
Fig. 23
Fig. 24
Fig. 25
Fig. 26
Fig. 27
Fig. 28

Similar content being viewed by others

References

  1. Osborne JD, Althaus T, Forny L, Niederreiter G, Palzer S, Hounslow MJ, et al. Investigating the influence of moisture content and pressure on the bonding mechanisms during roller compaction of an amorphous material. Chem Eng Sci. 2013;86:61–9, 2.

    Article  CAS  Google Scholar 

  2. Teng Y, Qiu Z, Wen H. Systematical approach of formulation and process development using roller compaction. Eur J Pham Biopharm. 2009;73:219–29, 10.

    Article  CAS  Google Scholar 

  3. Miller RW. In: Parikh DM, editor. Handbook of pharmaceutical granulation. Didcot: Taylor and Francis; 2005. p. 159–90.

    Chapter  Google Scholar 

  4. Gessel S, Druinen H, Bogaerts I. Roller compaction of anhydrous lactose and blends of anhydrous lactose with MCC, 2009.

  5. Kleinebudde P. Roll compaction/dry granulation: pharmaceutical applications. Eur J Pham Biopharm. 2004;58:317–26.

    Article  CAS  Google Scholar 

  6. Perez-Gandarillas L, Mazor A, Souriou D, Lecoq O, Michrafy A. Compaction behaviour of dry granulated binary mixtures. Powder Technol. 2015;285:62–7, 11.

    Article  CAS  Google Scholar 

  7. Hosokawa Micron, Nano Particle Technology and Particle Design, extracted from https://www.hosokawa.co.uk/wpcontent/uploads/2014/03/Nano_Particle_Technology__Particle_Design.pdf, 2004.

  8. Nara Machinery co. ltd. Nara Hybridization System Powder surface modification technology, extracted from http://www.aaamachine.com/products/other/pdf/Hybridization_NHS_NaraMachinery.pdf, 2011

  9. Pfeffer R, Dave RN, Wei D, Ramlakhan M. Synthesis of engineered particulates with tailored properties using dry particle coating. Powder Technol. 2001;117:40–67.

    Article  CAS  Google Scholar 

  10. Saharan VA, Kukkar V, Kataria M, Kharb V, Choudhury PK. Ordered mixing: mechanism, process and application in pharmaceutical formulations. Asian J Pharm Sci. 2008;3:240–59.

    Google Scholar 

  11. Hersey JA. Ordered mixing: a new concept in powder mixing practice. Powder Technol. 1975;11:41–4.

    Article  Google Scholar 

  12. Parikh DM. In: Parikh DM, editor. Handbook of pharmaceutical granulation. Didcot: Taylor and Francis; 2005. p. 1–6.

    Chapter  Google Scholar 

  13. Pietsch W. Agglomeration processes: phenomena, technologies, equipment, J. Wiley and Sons, Éds., Wiley-VCH, Hoboken, 2002.

  14. Alonso M, Alguacil FJ. Stochastic modeling of particle coating. AICHE J. 2001;47:1303–8.

    Article  CAS  Google Scholar 

  15. Gera M, Saharan VA, Kataria M, Kukkar V. Mechanical method for dry particle coating processes and their applications in drug delivery and development. Recent Pat Drug Deliv Formul. 2010;4:58–81.

    Article  CAS  PubMed  Google Scholar 

  16. Alonso M, Alguacil FJ. Dry mixing and coating of powders. Rev Metal. 1999;35:315–28.

    Article  CAS  Google Scholar 

  17. Polizzi M, Langdon BA, Beach L, Mullarney MP. Applying Dry Powder Coatings. Pharm Technol. 2011;212.3:397–402.

  18. Zhou Q, Armstrong B, Larson I, Stewart PJ, Morton DA. Improving powder flow properties of a cohesive lactose monohydrate powder by intensive mechanical dry coating. J Pharm Sci. 2010;99:969–81.

    Article  CAS  PubMed  Google Scholar 

  19. ASTM. Standard test method for shear testing of powders using the Freeman Technology FT4 powder rheometer shear cell. West Conshohocken: ASTM International; 2015.

  20. Hare C, Zafar U, Ghadiri M, Freeman T, Clayton J, Murtagh MJ. Analysis of the dynamics of the FT4 powder rheometer. Powder Technol. 2015;285:123–7.

    Article  CAS  Google Scholar 

  21. Freeman Technology, W7006 The conditioning process, 2006.

  22. Freeman Technology, W7013 Stability and variable flow rate method, 2007.

  23. Freeman Technology, W7030 The basic flowability energy, 2008.

  24. Freeman Technology, W7031 Specific energy, 2008.

  25. Freeman Technology, W7018 Shear cell, 2010.

  26. Leonard G, Abatzoglou N. Stress distribution in lubricated vs unlubricated pharmaceutical powder columns and their container walls during translational and torsional shear testing. Powder Technol. 2010;203:524–47.

    Article  CAS  Google Scholar 

  27. Rhodes M. Introduction to particle technology. Hoboken: J. Wiley et Sons, Éds., Wiley; 1998.

    Google Scholar 

  28. Schulze D. Powders and bulk solids: behavior, characterization, storage and flow. Heidelberg: Springer Berlin; 2008.

    Google Scholar 

  29. Enerpac, P-series lightweight hand pumps.

  30. GlobePharma, Manual tablet compaction machine model MTCM-I.

  31. Fu X, Huck D, Makein L, Armstrong B, Willen U, Freeman T. Effect of particle shape and size on flow properties of lactose powders. Particuology. 2012;10:203–8.

    Article  CAS  Google Scholar 

  32. Malkowska S, Khan A. Effect of re-compression on the properties of tablets prepared by dry granulation. Drug Dev Ind Pharm. 1983;9:331–47.

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The authors would like to thank the Natural Sciences and Engineering Research Council of Canada (NSERC), the Fonds de recherche du Quebec–Nature et technologies (FRQNT) and Pfizer for their financial support through the Industrial Innovation Scholarships Program (BMP Innovation). Secondly, the authors would like to thank Hosokawa Micron Powder Systems and more precisely C. C. Huang and M. Cavaliere. Finally, the authors would like to thank Pr. R. Gosselin.

Author information

Authors and Affiliations

  1. École Polytechnique de Montréal, 2500 Chemin de Polytechnique, Montreal, Québec, Canada

    Sophie Hudon & Michel Perrier

  2. Pfizer, 1025 Boul. Marcel-Laurin, Ville Saint-Laurent, Montreal, Québec, Canada

    Sophie Hudon, Pierre-Philippe Lapointe-Garant & Jean-Sébastien Simard

  3. Pfizer, 100 US-206, Peapack, NJ, USA

    Albert Pichieri, Stephen Hammond & George Sienkiewicz

  4. Université de Sherbrooke, 2500 boul. de l’Université, Sherbrooke, Québec, Canada

    Nicolas Abatzoglou

Authors
  1. Sophie Hudon
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Pierre-Philippe Lapointe-Garant
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jean-Sébastien Simard
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Albert Pichieri
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Stephen Hammond
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. George Sienkiewicz
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Nicolas Abatzoglou
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Michel Perrier
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Nicolas Abatzoglou.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Hudon, S., Lapointe-Garant, PP., Simard, JS. et al. Evaluation of a Dry Coating Technology as a Substitute for Roller Compaction for Dry Agglomeration Applications in the Pharmaceutical Industry. J Pharm Innov 14, 286–303 (2019). https://doi.org/10.1007/s12247-018-9353-x

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s12247-018-9353-x

Keywords

Search

Navigation