Comparison of low-shear and high-shear granulation processes: effect on implantable calcium phosphate granule properties

References

• Herath HMTU, Di Silvio L, Evans JRG. (2005). Porous hydroxyapatite ceramics for tissue engineering. J Appl Biomater Biomech, 3:192–8.
   PubMedGoogle Scholar
• Bae CJ, Kim HW, Koh YH, Kim HE. (2006). Hydroxyapatite bone scaffolds with controlled macrochannel pores. J Mater Sci Mater Med, 17:517–21.
   PubMed Web of Science ®Google Scholar
• Deville S, Saiz E, Tomsia AP. (2006). Freeze casting of hydroxyapatite scaffolds for bone tissue engineering. Biomaterials, 27:5480–9.
   PubMed Web of Science ®Google Scholar
• Otsuka M, Matsuda Y, Suwa Y, Fox JL, Higuchi WI. (1994). A novel skeletal drug-delivery system using self-setting calcium phosphate cement. 3. Physicochemical properties and drug- release rate of bovine insulin and bovine albumin. J Pharm Sci, 83:255–8.
   PubMed Web of Science ®Google Scholar
• Bohner M, Lemaître J, Van Landuyt P, Zambelli PY, Merkle HP, Gander B. (1997). Gentamicin-loaded hydraulic calcium phosphate bone cement as antibiotic delivery system. J Pharm Sci, 86:565–72.
   PubMed Web of Science ®Google Scholar
• Sivakumar M, Manjubala I, Panduranga Rao K. (2002). Preparation, characterization and in vitro release of gentamicin from coralline hydroxyapatite-chitosan composite microspheres. Carbohydr Polym, 49:281–8.
   Web of Science ®Google Scholar
• Ginebra MP, Traykova T, Planell JA. (2006). Calcium phosphate cements as drug delivery systems: A review. J Control Release, 113:102–10.
   PubMed Web of Science ®Google Scholar
• Chevalier E, Chulia D, Pouget C, Viana M. (2007). Fabrication of porous substrates: A review of processes using the pore forming agents in the biomaterial field. J Pharm Sci, 97:1135–54.
   Web of Science ®Google Scholar
• Hasegawa M, Sudo A, Komlev VS, Barinov SM, Uchida A. (2004). High release of antibiotic from a novel hydroxyapatite with bimodal pore size distribution. J Biomed Mater Res B Appl Biomater, 70B:332–9.
   Web of Science ®Google Scholar
• Uchida A, Nade SM, McCartney ER, Ching W. (1984). The use of ceramics for bone replacement. A comparative study of three different porous ceramics. J Bone Joint Surg, 66B:269–75.
   Google Scholar
• Daculsi G, Passuti N. (1990). Effect of the macroporosity for osseous substitution of calcium phosphate ceramics. Biomaterials, 11:86–7.
   PubMed Web of Science ®Google Scholar
• Lu JX, Gallur A, Flautre B, Anselme K, Descamps M, Thierry B, (1998). Comparative study of tissue reactions to calcium phosphate ceramics among cancellous, cortical and medullar bone sites in rabbits. J Biomed Mater Res, 42:357–67.
   PubMed Web of Science ®Google Scholar
• Flautre B, Descamps M, Delecourt C, Blary MC, Hardouin P. (2001). Porous HA ceramic for bone replacement: Role of the pores and interconnections—experimental study in the rabbit. J Mater Sci Mater Med, 12:679–82.
   PubMed Web of Science ®Google Scholar
• Yoshikawa H, Myoui A. (2005). Bone tissue engineering with porous hydroxyapatite ceramics. J Artif Organs, 8:131–6.
   PubMedGoogle Scholar
• Hulbert SF, Morrison SJ, Klawitter JJ. (1971). Compatibility of porous ceramics with soft tissue; application to tracheal prostheses. J Biomed Mater Res, 5:269–79.
   Google Scholar
• Van Blitterswijk CA, Grote JJ, Kuijpers W, Daems WT, de Groot K. (1986). Macropore tissue ingrowth: A quantitative and qualitative study on hydroxyapatite ceramic. Biomaterials, 7:137–43.
   PubMed Web of Science ®Google Scholar
• Komlev VS, Barinov SM. (2002). Porous hydroxyapatite ceramics of bi-modal pore size distribution. J Mater Sci Mater Med, 13:295–9.
   PubMed Web of Science ®Google Scholar
• Komath M, Varma HK, Sivakumar R. (2000). On the development of an apatitic calcium phosphate bone cement. Bull Mater Sci, 23:135–40.
   Web of Science ®Google Scholar
• Ratier A, Gibson IR, Best SM, Freche M, Lacout JL, Rodriguez F. (2001). Setting characteristics and mechanical behaviour of a calcium phosphate bone cement containing tetracycline. Biomaterials, 22:897–901.
   PubMed Web of Science ®Google Scholar
• Zoulgami M, Lucas A, Briard P, Gaudé J. (2001). A self-setting single-component calcium phosphate cement. Biomaterials, 22:1933–7.
   PubMed Web of Science ®Google Scholar
• Barralet JE, Grover L, Gaunt T, Wright AJ, Gibson IR. (2002). Preparation of macroporous calcium phosphate cement tissue engineering scaffold. Biomaterials, 23:3063–72.
   PubMed Web of Science ®Google Scholar
• del Real RP, Wolke JG, Vallet-Regí M, Jansen JA. (2002). A new method to produce macropores in calcium phosphate cements. Biomaterials, 23:3673–80.
   PubMed Web of Science ®Google Scholar
• Xu HHK, Weir MD, Burguera EF, Fraser AM. (2006). Injectable and macroporous calcium phosphate cement scaffold. Biomaterials, 27:4279–87.
   PubMed Web of Science ®Google Scholar
• Weiss P, Layrolle P, Clergeau LP, Enckel B, Pilet P, Amouriq Y, (2007). The safety and efficacy of an injectable bone substitute in dental sockets demonstrated in human clinical trial. Biomaterials, 28:3295–305.
   PubMed Web of Science ®Google Scholar
• Gauthier H, Daculsi G, Merle C. (2001). Association of vancomycin and calcium phosphate by dynamic compaction: In vitro characterization and microbiological activity. Biomaterials, 22:2481–7.
   PubMed Web of Science ®Google Scholar
• Sunder M, Babu NR, Victor SP, Kumar KR, Sampath Kumar TS. (2005). Biphasic calcium phosphates for antibiotic release. Trends Biomater Artif Organs, 18(2):213–8.
   Google Scholar
• Liu DM. (1996). Fabrication and characterization of porous hydroxyapatite granules. Biomaterials, 17:1955–7.
   Web of Science ®Google Scholar
• Rivera-Muñoz E, Díaz JR, Rogelio Rodríguez J, Brostow W, Castaño VM. (2001). Hydroxyapatite spheres with controlled porosity for eye ball prosthesis: Processing and characterization. J Mater Sci Mater Med, 12:305–11.
   PubMed Web of Science ®Google Scholar
• Paul W, Sharma CP. (1999). Development of porous spherical hydroxyapatite granules: Application towards protein delivery. J Mater Sci Mater Med, 10:383–8.
   PubMed Web of Science ®Google Scholar
• Lee JS, Park JK. (2003). Processing of porous ceramic spheres by pseudo-double-emulsion method. Ceram Int, 29:271–8.
   Google Scholar
• Ioku K, Kawachi G, Sasaki S, Fujimori H, Goto S. (2006). Hydrothermal preparation of tailored hydroxyapatite. J Mater Sci, 41:1341–4.
   Web of Science ®Google Scholar
• Hapgood KP, Lister JD, Smith R. (2003). Nucleation regime map for liquid bound granules. AIChE J, 49:350–61.
   Web of Science ®Google Scholar
• Laurent BFC. (2005). Structure of powder flow in a planetary mixer during wet-mass granulation. Chem Eng Sci, 60:3805–16.
   Web of Science ®Google Scholar
• Badawy SIF, Hussain MA. (2004). Effect of starting material particle size on its agglomeration behaviour in high shear wet granulation. AAPS PharmSciTech, 5:1–7.
   Google Scholar
• Benali M, Gerbaud V, Hemati M. (2009). Effect of operating conditions and physico-chemical properties on the wet granulation kinetics in high shear mixer. Powder Technol, 190:160–9.
   Web of Science ®Google Scholar
• Iveson SM, Litster JD, Hapgood K, Ennis BJ. (2001). Nucleation, growth and breakage phenomena in agitated wet granulation processes. A review. Powder Technol, 11:3–39.
   Google Scholar
• Mort PR, Tardos G. (1999). Scale-up of agglomeration processes using transformations. Kona, 17:64–75.
   Google Scholar
• Litster JD, Hapgood KP, Michaels JN, Kameneni SK, Hsu T, Sims A, (2001). Liquid distribution in wet granulation: Dimensionless spray flux. Powder Technol, 114:32–9.
   Web of Science ®Google Scholar
• Wauters PAL, Jakobsen RB, Litster JD, Meesters GMH, Scarlett B. (2002). Liquid distribution as a means to describing the granule growth mechanism. Powder Technol, 123:166–77.
   Web of Science ®Google Scholar
• Ghorab MK, Adeyeye MC. (2007). High shear mixing granulation of ibuprofen and β-cyclodextrin: Effects of process variables on ibuprofen dissolution. AAPS PharmSciTech, 8:1–9.
   PubMedGoogle Scholar
• Albertini B, Cavallari C, Passerini N, González-Rodríguez ML, Rodriguez L. (2003). Evaluation of β-lactose, PVP K12 and PVP K90 as excipients to prepare piroxicam granules using two wet granulation techniques. Eur J Pharm Biopharm, 56:479–87.
   PubMed Web of Science ®Google Scholar
• Ameye D, Keleb E, Vervaet C, Remon JP, Adams E, Massart DL. (2002). Scaling-up of a lactose wet granulation process in Mi-Pro high shear mixers. Eur J Pharm Sci, 17:247–51.
   PubMed Web of Science ®Google Scholar
• Hamdani J, Moës AJ, Amighi K. (2002). Development and evaluation of prolonged release pellets obtained by the melt pelletization process. Int. J Pharm, 245:167–77.
   Google Scholar
• Turchiuli C, Eloualia Z, El Mansouri N, Dumoulin E. (2005). Fluidised bed agglomeration: Agglomerates shape and end-use properties. Powder Technol, 157:168–75.
   Web of Science ®Google Scholar
• Hiseman MJP, Laurent BFC, Bridgwater J, Wilson DI, Parker JD, North N, (2002). Granular flow in a planetary mixer. Trans IChemE, 80:432–40.
   Google Scholar
• Vonk P, Guillaume CPF, Ramaker JS, Vromans H, Kossen NWF. (1997). Growth mechanisms of high-shear pelletisation. Int J Pharm, 157:93–102.
   Web of Science ®Google Scholar
• Chevalier E, Viana M, Pouget C, Cazalbou S, Champion E, Chulia D. (2009). Safford MP, Haines JG, eds. Bioceramics: Properties, preparation and applications, Hauppauge, NY: Nova Science Publishers Inc, 27.
   Google Scholar
• Chevalier E, Viana M, Pouget C, Chulia D. (2007). Influence of process parameters on pellets elaborated in a Mi-Pro high-shear granulator. Pharm Dev Technol, 12:133–44.
   PubMed Web of Science ®Google Scholar
• Viana M, Jouannin P, Pontier C, Chulia D. (2002). About pycnometric density measurements. Talanta, 57:583–93.
   PubMed Web of Science ®Google Scholar
• Brunauer S, Emmett PH, Teller E. (1938). The use of low temperature Van der Waals adsorption isotherm in determining surface area. J Am Chem Soc, 60:309–17.
   Web of Science ®Google Scholar
• Gabaude CMD, Gautier JC, Saudemon P, Chulia D. (2001). Validation of a new pertinent packing coefficient to estimate flow properties of pharmaceutical powders at a very early development stage, by comparison with mercury intrusion and classical flowability methods. J Mater Sci, 36:1763–73.
   Web of Science ®Google Scholar
• . (2008). European Pharmacopoeia, 6th ed. Strasbourg: Council of Europe.
   Google Scholar
• Gibassier D, Sado P, Le Verge R, Devissaguet JP. (1982). Test de dissolution et fonction de Weibull. Labo Pharma Prob Techn, 30:250–5.
   Google Scholar
• Costa P, Sousa Lobo JM. (2001). Modelling and comparison of dissolution profiles. Eur J Pharm Sci, 13:123–33.
   PubMed Web of Science ®Google Scholar
• Moore JW, Flanner HH. (1996). Mathematical comparison of curves with an emphasis on in vitro dissolution profiles. Pharm Tech, 20:64–74.
   Google Scholar
• Shah VP, Tsong Y, Sathe P. (1998). In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2. Pharm Res, 15:889–96.
   PubMed Web of Science ®Google Scholar
• Higuchi T. (1963). Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci, 52:1145–9.
   PubMed Web of Science ®Google Scholar
• Hixson AW, Crowell JH. (1931). Dependence of reaction velocity upon surface and agitation. Ind Eng Chem, 23:923–31.
   Google Scholar
• Kopcha M, Lordi N, Tojo KJ. (1991). Evaluation of release from selected thermosoftening vehicles. J Pharm Pharmacol, 43:382–7.
   PubMed Web of Science ®Google Scholar
• Pontier C. (2001). Les phosphates de calcium apatitiques en compression. De la chimie aux qualités d'usage. PhD thesis, Université de Paris XI, Chatenay-Malabry.
   Google Scholar
• Raynaud S, Champion E, Bernache-Assollant D. (1998). Synthesis, sintering and mechanical characteristics of non stoechiometric apatite ceramics. 11th international symposium on ceramics in medicine, New York. Bioceramics, 11:109–12.
   Google Scholar
• Shiromani PK, Clair J. (2000). Statistical comparison of high-shear versus low-shear granulation using a common formulation. Drug Dev Ind Pharm, 26:357–64.
   PubMed Web of Science ®Google Scholar
• Sheskey PJ, Williams DM. (1996). Comparison of low-shear and high-shear wet granulation techniques and the influence of percent water addition in the preparation of a controlled-release matrix tablet containing HPMC and a high-dose, highly water-soluble drug. Pharm Technol, 20:80–92.
   Google Scholar
• Visavarungroj N, Remon JP. (1991). Crosslinked starch as binding agent. III. Granulation of an insoluble filler. Int J Pharm, 69:43–51.
   Web of Science ®Google Scholar
• Isobe T, Kameshima Y, Nakajima A, Okada K, Hotta Y. (2006). Extrusion method using nylon 66 fibers for the preparation of porous alumina ceramics with oriented pores. J Eur Ceram Soc, 26:2213–7.
   Web of Science ®Google Scholar
• Markovic M, Takagi S, Chow LC. (2001). Formation of macroporous phosphate cements through the use of mannitol crystals. Key Eng Mater, 192:773–6.
   Google Scholar