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Melt Extrusion pp 447-458 | Cite as

Melt Extrusion: A Commercial Perception to Practicality

Lessons Learned from Meltrex® Technology
Chapter
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 9)

Abstract

Over the past two decades, Meltrex® has evolved from being a novel processing technique into a comprehensive manufacturing technology. This chapter discusses the successful application of Meltrex® in the commercial development of delivery systems for varied drugs such as lopinavir (Kaletra®), ritonavir (Norvir®), ibuprofen, and verapamil hydrochloride (Isoptin®). Besides the commercial applications, Meltrex® can be successfully applied in design of solid dispersions (bioavailability enhancement of poorly soluble drugs), alter or control dissolution profiles (sustained release), reduced dosing frequency, deter substance abuse, improve safety, and efficacy of drugs. Moreover, continuous processing, rigorous and comprehensive regulatory documentation, and use of generally regarded as safe (GRAS) material are some of the striking features which make Meltrex® a popular drug delivery technology.

Keywords

Solid Dispersion Area Under Curve Tablet Formulation Amorphous Solid Dispersion Sustained Release Formulation 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. AbbVie Deutschland GmbH & Co (2012) SOLIQS Global Drug Delivery Business, Germany. www.soliqs.com Accessed Nov 2012
  2. Andrews GP, Abu-Diak O et al (2010) Physicochemical characterization and drug-release properties of celecoxib hot-melt extruded glass solutions. J Pharm Pharmacol 62(11):1580–1590PubMedCrossRefGoogle Scholar
  3. Bosch (2012) Technical literature on BOSCH hot melt extrusion lineWCF, BPK, BCK. Robert Bosch GmbH, Packaging Technology Division, Germany. www.boschconfectionery.com
  4. Breitenbach J (2002) Melt extrusion: from process to drug delivery technology. Eur J Pharm Biopharm 54(2):107–117PubMedCrossRefGoogle Scholar
  5. Breitenbach J (2006) Melt extrusion can bring new benefits to HIV therapy: the example of Kaletra® Tablets. Am J Drug Deliv 4(2):61–64CrossRefGoogle Scholar
  6. Breitenbach J, Lewis J (2008) Two concepts, one technology: controlled-release solid dispersions using melt extrusion (Meltrex®). In: Rathbone MJ, Roberts MS (eds) Modified-release drug delivery technology. Informa Healthcare, New York, pp 179–186Google Scholar
  7. Chiou WL, Riegelman S (1971) Pharmaceutical applications of solid dispersion systems. J Pharm Sci 60:1281–1302. doi: 10.1002/jps.2600600902Google Scholar
  8. Crowley MM, Zhang F et al (2007) Pharmaceutical applications of hot-melt extrusion: part I. Drug Dev Ind Pharm 33(9):909–926PubMedCrossRefGoogle Scholar
  9. Croxtall JD, Perry CM (2010) Lopinavir/ritonavir: a review of its use in the management of HIV-1 infection. Drugs 70(14):1885–915PubMedCrossRefGoogle Scholar
  10. Cvetkovic RS, Goa KL (2003) Lopinavir/ritonavir: a review of its use in the management of HIV infection. Drugs 63(8):769–802PubMedCrossRefGoogle Scholar
  11. Feng J, Xu L et al (2011) Evaluation of polymer carriers with regard to the bioavailability enhancement of bifendate solid dispersions prepared by hot-melt extrusion. Drug Dev Ind Pharm 38(6):735–743PubMedCrossRefGoogle Scholar
  12. Janssens S, Van den Mooter G (2009) Review: physical chemistry of solid dispersions. J Pharm Pharmacol 61(12):1571–1586PubMedCrossRefGoogle Scholar
  13. Klein CE, Chiu YL et al (2007) The tablet formulation of lopinavir/ritonavir provides similar bioavailability to the soft-gelatin capsule formulation with less pharmacokinetic variability and diminished food effect. J Acquir Immune Defic Syndr 44(4):401–410PubMedCrossRefGoogle Scholar
  14. Klueglich M, Ring A et al (2005) Ibuprofen extrudate, a novel, rapidly dissolving ibuprofen formulation: relative bioavailability compared to ibuprofen lysinate and regular ibuprofen, and food effect on all formulations. J Clin Pharmacol 45(9):1055–1061PubMedCrossRefGoogle Scholar
  15. Lakshman JP, Cao Y et al (2008) Application of melt extrusion in the development of a physically and chemically stable high-energy amorphous solid dispersion of a poorly water-soluble drug. Mol Pharm 5(6):994–1002PubMedCrossRefGoogle Scholar
  16. Leuner C, Dressman J (2000) Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 50(1):47–60PubMedCrossRefGoogle Scholar
  17. Liu X, Lu M et al (2012) Improving the chemical stability of amorphous solid dispersion with cocrystal technique by hot melt extrusion. Pharm Res 29(3):806–817PubMedCrossRefGoogle Scholar
  18. Oldfield V, Plosker GL (2006) Lopinavir/ritonavir: a review of its use in the management of HIV infection. Drugs 66(9):1275–1299PubMedCrossRefGoogle Scholar
  19. Repka MA, Majumdar S et al (2008) Applications of hot-melt extrusion for drug delivery. Expert Opin Drug Deliv 5(12):1357–1376PubMedCrossRefGoogle Scholar
  20. Roth W, Setnik B et al (2009) Ethanol effects on drug release from Verapamil Meltrex, an innovative melt extruded formulation. Int J Pharm 368(1–2):72–75PubMedCrossRefGoogle Scholar
  21. Sakurai A, Sakai T et al (2012) Polymer combination increased both physical stability and oral absorption of solid dispersions containing a low glass transition temperature drug: physicochemical characterization and in vivo study. Chem Pharm Bull (Tokyo) 60(4):459–464CrossRefGoogle Scholar
  22. Serajuddin AT (1999) Solid dispersion of poorly water-soluble drugs: early promises, subsequent problems, and recent breakthroughs. J Pharm Sci 88(10):1058–1066PubMedCrossRefGoogle Scholar
  23. Shah S, Maddineni S et al (2012) Melt extrusion with poorly soluble drugs. Int J Pharm S0378–S5173(12):00990–00998Google Scholar
  24. Tho I, Liepold B et al (2010) Formation of nano/micro-dispersions with improved dissolution properties upon dispersion of ritonavir melt extrudate in aqueous media. Eur J Pharm Sci 40(1):25–32PubMedCrossRefGoogle Scholar
  25. von Hentig N (2007) Lopinavir/ritonavir: appraisal of its use in HIV therapy. Drugs Today (Barc) 43(4):221–247CrossRefGoogle Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2013

Authors and Affiliations

  1. 1.Department of Pharmaceutics, School of PharmacyThe University of MississippiUniversityUSA
  2. 2.Abbott GmbH & Co. KGLudwigshafenGermany

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