Advertisement

AAPS PharmSciTech

, Volume 8, Issue 1, pp E137–E141 | Cite as

Influence of operational variables on properties of piroxicam pellets prepared by extrusion-spheronization: A technical note

  • Vivek R. SinhaEmail author
  • Manoj K. Agrawal
  • Rachna Kumria
  • Jayant R. Bhinge
Article

Summary and Conclusion

The processing conditions has a pronounced effect on the pellet properties. Drying conditions influenced the mean size and the drug release of the pellets. Because of the shrinking of the pellets upon drying at higher temperatures, the pellets also showed increased densities. Freeze drying almost prevented shrinking and thus led to the highest drug release. With an increase in the temperature of drying, the drug release rate decreased.

Both spheronization time and spheronization speed affected the shapes of pellets, and the changes in shapes then affected the pellet flow properties. Within the studied range, the circularity of the pellets was affected more by the spheronization time than by the spheronization speed. Drying conditions influenced pellet friability, which decreased with an increase in drying temperature, indicating the formation of more dense structures at higher temperatures. The same result was obtained with spheronization time. With an increase in spheronization time, the friability decreased, because of the formation of more compact masses at higher spheronization time. Mean size was not affected by spheronization time or spheronization speed.

Keywords

Extrusion spheronization pellets microcrystalline cellulose 

References

  1. 1.
    Koo OMY, Heng PWS. The influence of microcrystalline cellulose grade on shape and shape distributions of pellets produced by extrusion-spheronization.Chem Pharm Bull (Tokyo). 2001;49:1383–1387.CrossRefGoogle Scholar
  2. 2.
    Mehta KA, Kislalioglu MS, Phuapradit W, Malick AW, Shah NH. Effect of formulation and process variables on porosity parameters and release rates from a multi unit erosion matrix of a poorly soluble drug.J Control Release. 2000;63:201–211.CrossRefGoogle Scholar
  3. 3.
    Kojima M, Nakagami H. Development of controlled release matrix pellets by annealing with micronized water-insoluble or enteric polymers.J Control Release. 2002;82:335–343.CrossRefGoogle Scholar
  4. 4.
    Elchidana PA, Deshpande SG. Microporous membrane drug delivery system for indomethacin.J Control Release. 1999;59:279–285.CrossRefGoogle Scholar
  5. 5.
    Alvarez L, Concheiro A, Gomez-Amoza JL, Souto C, Martinez-Pacheco R. Effect of microcrystalline cellulose grade and process variables on pellets prepared by extrusion-spheronization.Drug Dev Ind Pharm. 2002;28:451–456.CrossRefGoogle Scholar
  6. 6.
    Law MF, Deasy P. Effect of common classes of excipients on extrusion-spheronization.J Microencapsul. 1997;14:647–657.Google Scholar
  7. 7.
    Boutell S, Newton JM, Bloor JR, 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.CrossRefGoogle Scholar
  8. 8.
    Dupont G, Flament MP, Leterme P, Farah N, Gayot A. Developing a study method for producing 400 micron spheroids.Int J Pharm. 2002;247:159–165.CrossRefGoogle Scholar
  9. 9.
    Kleinebudde P, Lindner H. Experiments with an instrumented twin-screw extruder using a single-step granulation/extrusion process.Int J Pharm. 1993;94:49–58.CrossRefGoogle Scholar
  10. 10.
    Heng PWS, Liew CV, Gu L. Influence of tear drop studs on rotating frictional base plate on spheroid quality in rotary spheronization.Int J Pharm. 2002;241:173–184.CrossRefGoogle Scholar
  11. 11.
    Newton JM, Chapman SR, Rowe RC. The assessment of the scale-up performance of the extrusion/spheronization process.Int J Pharm. 1995;120:95–99.CrossRefGoogle Scholar
  12. 12.
    Gouldson MP, Deasy PB. Use of cellulose ether containing excipients with microcrystalline cellulose for the production of pellets containing metformin hydrochloride by the process of extrusion-spheronization.J Microencapsul. 1997;14:137–153.CrossRefGoogle Scholar
  13. 13.
    Agrawal AM, Howard MA, Neau SH. Extruded and spheronized beads containing no microcrystalline cellulose: influence of formulation and process variables.Pharm Dev Technol. 2004;9:197–217.CrossRefGoogle Scholar
  14. 14.
    Wells JI.Pharmaceutical Preformulation: The Physicochemical Properties of Drug Substance. West Sussex, UK: Wells/Ellis Horwood; 1988.Google Scholar
  15. 15.
    Perez J, Rabiskova M. Influence of the drying technique on theophylline pellets prepared by extrusion-spheronization.Int J Pharm. 2002;242:349–351.CrossRefGoogle Scholar
  16. 16.
    Iyer RM, Augsburger LL, Pope DG, Shah RD. Extrusion/spheronization—effect of moisture content and spheronization time on pellet characteristics.Pharm Dev Technol. 1996;1:325–331.CrossRefGoogle Scholar
  17. 17.
    Umprayn K, Chitropas P, Amarekajorn S. Influence of process variables on physical properties of the pellets using extruder and spheronizer.Drug Dev Ind Pharm. 1999;25:45–61.Google Scholar
  18. 18.
    Higuchi T. Mechanism of sustained action medication.J Pharm Sci. 1963;52:1145–1149.CrossRefGoogle Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2007

Authors and Affiliations

  • Vivek R. Sinha
    • 1
    Email author
  • Manoj K. Agrawal
    • 2
  • Rachna Kumria
    • 3
  • Jayant R. Bhinge
    • 1
  1. 1.University Institute of Pharmaceutical SciencesPanjab UniversityChandigarhIndia
  2. 2.Ranbaxy Laboratories LtdPaonta SahibIndia
  3. 3.Ind-Swift Laboratories LtdParwanooIndia

Personalised recommendations