The impact of hot melt extrusion and spray drying on mechanical properties and tableting indices of materials used in pharmaceutical development

Journal of Pharmaceutical Sciences

Volumn 102, Issue 10, 2013, Pages 3604-3613

  Iyer, Raman ^a   Hegde, Shridhar ^a   Zhang, Yu E ^a   Dinunzio, James ^a   Singhal, Dharmendra ^b   Malick, A ^a   Amidon, Gregory ^c  

^a HOFFMANN LA ROCHE INC   (United States)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c UNIVERSITY OF MICHIGAN   (United States)

Author keywords

Compaction; Compression; Excipients; Extrusion; Formulation; Hardness; Hiestand indices; Mechanical properties; Spray drying; Tableting

Indexed keywords

EXCIPIENT; MICROCRYSTALLINE CELLULOSE;

ARTICLE; CONTROLLED STUDY; DENSITY; DRUG MANUFACTURE; ELASTICITY; HOT MELT EXTRUSION; MECHANICS; PLASTICITY; SHEAR STRESS; SPRAY DRYING; TABLET COMPRESSION; TABLET HARDNESS; TABLET MANUFACTURE; TENSILE STRENGTH; VISCOELASTICITY; YOUNG MODULUS;

COMPACTION; COMPRESSION; EXCIPIENTS; EXTRUSION; FORMULATION; HARDNESS; HIESTAND INDICES; MECHANICAL PROPERTIES; SPRAY DRYING; TABLETING;

CELLULOSE; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; EXCIPIENTS; HARDNESS; HOT TEMPERATURE; METHYLCELLULOSE; PYRROLIDINES; SHEAR STRENGTH; TABLETS; TENSILE STRENGTH; VINYL COMPOUNDS;

EID: 84883745681     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23661     Document Type: Article

References (37)

1. Hlinak AJ, Kuriyan K, Morris KR, Reklaitis GV, Basu PK. 2006. Understanding critical material properties for solid dosage form design. J Pharm Innovation 1(1):12-17.
2. Vachon MG, Chulia D. 1999. The use of energy indices in estimating powder compaction functionality of mixtures in pharmaceutical tableting. Int J Pharm 177(2):183-200.
3. Amidon GE. 1995. Physical and mechanical property characterization of powders. In Physical characterization of pharmaceutical solids; Brittain HG, Ed. Vol. 70. 1st ed. New York: Informa Healthcare, pp 281-317.
4. Amidon GE, Secreast PJ. 2009. Particle powder and compact characterization. In Pharmaceutical theory and practice in developing solid oral dosage forms; Qiu Y, Chen Y, Zhang GGZ, Lirong L, Porter WR, Eds. 1st ed. London: Academic Press, pp 163-183.
5. Jain S. 1999. Mechanical properties of powders for compaction and tableting: An overview. Pharm Sci Technol Today 2(1):20-31.
6. Final report on pharmaceutical cGMPs for 21st century-A risk-based approach. At: http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004 Last accessed August 9, 2013.
7. Yu LX. 2008. Pharmaceutical quality by design: Product and process development, understanding, and control. Pharm Res 25(4):781-791.
8. Tye CK, Sun CC, Amidon GE. 2005. Evaluation of the effects of tableting speed on the relationships between compaction pressure, tablet tensile strength, and tablet solid fraction. J Pharm Sci 94:465-472.
9. Hiestand EN, Smith DP. 1984. Three indices for characterizing the tableting performance of materials. Adv Ceram 9:47-57 (1984).
10. Hiestand EN, Smith DP. 1984. Indices of tableting performance. Powder Technol 38:145-159.
11. Hiestand EN. 1986. Tablet bond and related measurements. Pharm Tech 10:52-58.
12. Hiestand EN. 1989. The basis for practical applications of the tableting indices. Pharm Tech 9:54-66.
13. Hiestand EN. 1997. Mechanical properties of compacts and particles that control tableting success. J Pharm Sci 86:985-990.
14. Venkatesh GM, Coleman JN, Wrzosek TJ, Duddu S, Palepu NR, Bandyopadhyay R, Grant DJW. 1998. Fractional factorial designs for optimizing experimental conditions for Hiestand's indices of tableting performance. Powder Technol 97(2):151-159.
15. Imbert C, Tchoreloff P, Leclerc B, Couarraze G. 1997. Indices of tableting performance and application of percolation theory to powder compaction. Eur J Pharm Biopharm 44(3):273-282.
16. Wurster DE, Likitlersuang S, Chen Y. 2005. The influence of magnesium stearate on the Hiestand tableting indices and other related mechanical properties of maltodextrins. Pharm Dev Technol 10(4):461-466.
17. Uhumwangho MU, Okor RS, Eichie FE, Abbah CM. 2006. Influence of some starch binders on the brittle fracture tendency of paracetamol tablets. Afr J Biotechnol 5(20):1950-1953.
18. Sever NE, Ibrahim R, Sharma S, Schmidt C, Wu H, Haight A. 2003. Hiestand indices predict tablet compression behavior. AAPS Poster # W4316. http://abstracts.aaps.org/published. to ALL]
19. Wurster DE, Majuru S, Oh E. 1999. Prediction of the Hiestand bonding indices of binary powder mixtures from single component bonding indices. Pharm Dev Technol 4(1):65-70.
20. Majuru S, Wurster DE. 1997. The effect of composition on the tableting indices of binary powder mixtures. Pharm Dev Technol 2(4):313-321.
21. Kuppuswamy R, Anderson SR, Hoag SW, Augsburger LL. 2001. Practical limitations of tableting indices. Pharm Dev Technol 6(4):505-520.
22. Amidon GE, Houghton ME. 1995. The effect of moisture on the mechanical and powder flow properties of microcrystalline cellulose. Pharm Res 12(6):923-929.
23. Crowley MM, Zhang F, Repka MA, Thumma S, Upadhye SB, Battu SK, McGinity JW, Martin C. 2007. Pharmaceutical applications of hot-melt extrusion: Part I. Drug Dev Ind Pharm. 33(9):909-926.
24. Repka MA, Battu SK, Upadhye SB, Thumma S, Crowley MM, Zhang F, Martin C, McGinity JW. 2007. Pharmaceutical applications of hot-melt extrusion: Part II. Drug Dev Ind Pharm. 33(10):1043-1057.
25. Chokshi RJ, Sandhu HK, Iyer RM, Shah NH, Malick AW, Zia H. 2005. Characterization of physico-mechanical properties of indomethacin and polymers to assess their suitability for hot-melt extrusion process as a means to manufacture solid dispersion/solution. J Pharm Sci 94(11):2463-2474.
26. Friesen DT, Shanker R, Crew M, Smithey DT, Curatolo WJ, Nightingale JAS. 2008. Hydroxypropyl methylcellulose acetate succinate-based spray-dried dispersions: An overview. Mol Pharm 5(6):1003-1019.
27. Janssens S, Mooter GV. 2009. Physical chemistry of solid dispersions. J Pharm Pharmacol 61:1571-1586.
28. Aharoni SM. 1998. Increased glass transition temperature in motionally constrained semicrystalline polymers. Polym Adv Technol 9(3):169-201.
29. Repka MA, Gerding TG, Repka SL, McGinity JW. 1999. Influence of plasticizers and drugs on the physical-mechanical properties of hydroxypropylcellulose films prepared by hot-melt extrusion. Drug Dev Ind Pharm 25(5):625-633.
30. Crowley MM, Fredersdorf A, Schroeder B, Ucera S, Prodduturi S, Repka MA. 2004. The influence of guaifenesin and ketoprofen on the properties of hot-melt extruded polyethylene oxide films. Eur J Pharm Sci 22(5):409-418.
31. Zhu Y, Shah NH, Malick AW, Infeld MH, McGinity JW. 2002. Influence of thermal processing on the properties of chlorpheniramine maleate tablets containing an acrylic polymer. Pharm Dev Technol 7(4):481-489.
32. Young CR, Dietzsch C, McGinity JW. 2005. Compression of controlled-release pellets produced by a hot-melt extrusion and spheronization process. Pharm Dev Technol 1:133-139.
33. Crowley MM, Schroeder B, Fredersdorf A, Obara S, Talarico M, Kucera S. 2004. Physicochemical properties and mechanism of drug release from ethyl cellulose matrix tablets prepared by direct compression and hot-melt extrusion. Int J Pharm 271(1-2):77-84.
34. Carlson GT, Hancock BC. 2006. A comparison of physical and mechanical properties of common tableting diluents. In Excipient development for pharmaceutical, biotechnology, and drug delivery systems Katdare AV, Chaubal MV, Eds. 1st ed. New York: Informa Healthcare, pp 127-153.
35. He X, Secreast PJ, Amidon GE. 2007. Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength. J Pharm Sci 96(5):1342-1355.
36. Ryskevitch E. 1953. Discussion of ball milling of pure ceramics diborides. J Am Ceram Soc 36:65-68.
37. Sarode A, Sandhu H, Iyer R, Shah N, Obara S, Tanno FK, Zia H. 2009. Stability assessment of hypromellose acetate succinate NF (HPMCAS) for application in hot melt extrusion. AAPS Poster # T3368. http://abstracts.aaps.org/published. to ALL]