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

Drug Development and Industrial Pharmacy

Volumn 35, Issue 10, 2009, Pages 1255-1263

  Chevalier, E ^a   Viana, M ^a   Cazalbou, S ^b   Chulia, D ^a  

^a UNIVERSITY OF LIMOGES   (France)

^b INSTITUT CARNOT CIRIMAT   (France)

Author keywords

Bioceramics; Bone filling; Calcium phosphate; Dissolution; High shear process; Ibuprofen; Low shear process; Physicochemical properties; Porosity; Wet granulation

Indexed keywords

BIOCERAMICS; CALCIUM PHOSPHATE; IBUPROFEN;

ARTICLE; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG RELEASE; IN VITRO STUDY; PHYSICAL CHEMISTRY; POROSITY; SCANNING ELECTRON MICROSCOPY; SHEAR STRENGTH;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BIOCOMPATIBLE MATERIALS; BONE CEMENTS; CALCIUM PHOSPHATES; CERAMICS; CHEMISTRY, PHARMACEUTICAL; DIFFUSION; DRUG DELIVERY SYSTEMS; IBUPROFEN; POROSITY; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL;

EID: 70350671698     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.1080/03639040902882298     Document Type: Article

References (66)

1. Herath HMTU, Di Silvio L, Evans JRG. (2005). Porous hydroxyapatite ceramics for tissue engineering. J Appl Biomater Biomech, 3:192-198
2. Bae CJ, Kim HW, Koh YH, Kim HE. (2006). Hydroxyapatite bone scaffolds with controlled macrochannel pores. J Mater Sci Mater Med, 17:517-521
3. Deville S, Saiz E, Tomsia AP. (2006). Freeze casting of hydroxyapatite scaffolds for bone tissue engineering. Biomaterials, 27:5480-5489
4. 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 drugrelease rate of bovine insulin and bovine albumin. J Pharm Sci, 83:255-258 (Pubitemid 24224189)
5. 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, 86:565-572
6. Sivakumar M, Manjubala I, Panduranga Rao K. (2002). Preparation, characterization and in vitro release of gentamicin from coralline hydroxyapatite-chitosan composite microspheres. Carbohydr Polym, 49:281-288 (Pubitemid 34466724)
7. Ginebra MP, Traykova T, Planell JA. (2006). Calcium phosphate cements as drug delivery systems: A review. J Control Release, 113:102-110
8. 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, 97:1135-1154
9. 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:332-339
10. 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:269-275
11. Daculsi G, Passuti N. (1990). Effect of the macroporosity for osseous substitution of calcium phosphate ceramics. Biomaterials, 11:86-87
12. Lu JX, Gallur A, Flautre B, Anselme K, Descamps M, Thierry B, et al. (1998). Comparative study of tissue reactions to calcium phosphate ceramics among cancellous, cortical and medullar bone sites in rabbits. J Biomed Mater Res, 42:357-367
13. 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, 12:679-682
14. Yoshikawa H, Myoui A. (2005). Bone tissue engineering with porous hydroxyapatite ceramics. J Artif Organs, 8:131-136
15. Hulbert SF, Morrison SJ, Klawitter JJ. (1971). Compatibility of porous ceramics with soft tissue; application to tracheal prostheses. J Biomed Mater Res, 5:269-279
16. 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, 7:137-143
17. Komlev VS, Barinov SM. (2002). Porous hydroxyapatite ceramics of bi-modal pore size distribution. J Mater Sci Mater Med, 13:295-299
18. Komath M, Varma HK, Sivakumar R. (2000). On the development of an apatitic calcium phosphate bone cement. Bull Mater Sci, 23:135-140
19. 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.
20. Zoulgami M, Lucas A, Briard P, Gaudé J. (2001). A self-setting single-component calcium phosphate cement. Biomaterials, 22:1933-1937
21. Barralet JE, Grover L, Gaunt T, Wright AJ, Gibson IR. (2002). Preparation of macroporous calcium phosphate cement tissue engineering scaffold. Biomaterials, 23:3063-3072
22. del Real RP, Wolke JG, Vallet-Regí M, Jansen JA. (2002). A new method to produce macropores in calcium phosphate cements. Biomaterials, 23:3673-3680
23. Xu HHK, Weir MD, Burguera EF, Fraser AM. (2006). Injectable and macroporous calcium phosphate cement scaffold. Biomaterials, 27:4279-4287
24. Weiss P, Layrolle P, Clergeau LP, Enckel B, Pilet P, Amouriq Y, et al. (2007). The safety and efficacy of an injectable bone substitute in dental sockets demonstrated in human clinical trial. Biomaterials, 28:3295-3305
25. Gauthier H, Daculsi G, Merle C. (2001). Association of vancomycin and calcium phosphate by dynamic compaction: In vitro characterization and microbiological activity. Biomaterials, 22:2481-2487
26. Sunder M, Babu NR, Victor SP, Kumar KR, Sampath Kumar TS. (2005). Biphasic calcium phosphates for antibiotic release. Trends Biomater Artif Organs, 18(2):213-218
27. Liu DM. (1996). Fabrication and characterization of porous hydroxyapatite granules. Biomaterials, 17:1955-1957
28. 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, 12:305-311
29. Paul W, Sharma CP. (1999). Development of porous spherical hydroxyapatite granules: Application towards protein delivery. J Mater Sci Mater Med, 10:383-388
30. Lee JS, Park JK. (2003). Processing of porous ceramic spheres by pseudo-double-emulsion method. Ceram Int, 29:271-278
31. Ioku K, Kawachi G, Sasaki S, Fujimori H, Goto S. (2006). Hydrothermal preparation of tailored hydroxyapatite. J Mater Sci, 41:1341-1344
32. Hapgood KP, Lister JD, Smith R. (2003). Nucleation regime map for liquid bound granules. AIChE J, 49:350-361
33. Laurent BFC. (2005). Structure of powder flow in a planetary mixer during wet-mass granulation. Chem Eng Sci, 60:3805-3816
34. 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.
35. 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, 190:160-169
36. 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.
37. Mort PR, Tardos G. (1999). Scale-up of agglomeration processes using transformations. Kona, 17:64-75.
38. Litster JD, Hapgood KP, Michaels JN, Kameneni SK, Hsu T, Sims A, et al. (2001). Liquid distribution in wet granulation: Dimensionless spray flux. Powder Technol, 114:32-39
39. Wauters PAL, Jakobsen RB, Litster JD, Meesters GMH, Scarlett B. (2002). Liquid distribution as a means to describing the granule growth mechanism. Powder Technol, 123:166-177
40. Ghorab MK, Adeyeye MC. (2007). High shear mixing granulation of ibuprofen and ?-cyclodextrin: Effects of process variables on ibuprofen dissolution. AAPS PharmSciTech, 8:1-9.
41. Albertini B, Cavallari C, Passerini N, González-Rodríguez ML, Rodriguez L. (2003). Evaluation of ?-lactose, PVP K12 and PVP K90 as excipients to prepare piroxicam granules using two wet granulation techniques. Eur J Pharm Biopharm, 56:479-487
42. 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, 17:247-251
43. Hamdani J, Moës AJ, Amighi K. (2002). Development and evaluation of prolonged release pellets obtained by the melt pelletization process. Int J Pharm, 245:167-177
44. Turchiuli C, Eloualia Z, El Mansouri N, Dumoulin E. (2005). Fluidised bed agglomeration: Agglomerates shape and end-use properties. Powder Technol, 157:168-175
45. Hiseman MJP, Laurent BFC, Bridgwater J, Wilson DI, Parker JD, North N, et al. (2002). Granular flow in a planetary mixer. Trans IChemE, 80:432-440
46. Vonk P, Guillaume CPF, Ramaker JS, Vromans H, Kossen NWF. (1997). Growth mechanisms of high-shear pelletisation. Int J Pharm, 157:93-102.
47. Chevalier E, Viana M, Pouget C, Cazalbou S, Champion E, Chulia D. (2009). In: Safford MP, Haines JG. eds. Bioceramics: Properties, preparation and applications. (Hauppauge, NY): Nova Science Publishers Inc., pp. 27.
48. Chevalier E, Viana M, Pouget C, Chulia D. (2007). Influence of process parameters on pellets elaborated in a Mi-Pro highshear granulator. Pharm Dev Technol, 12:133-144
49. Viana M, Jouannin P, Pontier C, Chulia D. (2002). About pycnometric density measurements. Talanta, 57:583-593
50. 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, 60:309-317
51. 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, 36:1763-1773
52. European Pharmacopoeia 6th ed., Council of Europe, Strasbourg. (2008).
53. Gibassier D, Sado P, Le Verge R, Devissaguet JP. (1982). Test de dissolution et fonction de Weibull. Labo Pharma Prob Techn, 30:250-255
54. Costa P, Sousa Lobo JM. (2001). Modelling and comparison of dissolution profiles. Eur J Pharm Sci, 13:123-133
55. Moore JW, Flanner HH. (1996). Mathematical comparison of curves with an emphasis on in vitro dissolution profiles. Pharm Tech, 20:64-74.
56. Shah VP, Tsong Y, Sathe P. (1998). In vitro dissolution profile comparison-statistics and analysis of the similarity factor, f2. Pharm Res, 15:889-896
57. Higuchi T. (1963). Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices. J Pharm Sci, 52:1145-1149
58. Hixson AW, Crowell JH. (1931). Dependence of reaction velocity upon surface and agitation. Ind Eng Chem, 23:923-931
59. Kopcha M, Lordi N, Tojo KJ. (1991). Evaluation of release fromselected thermosoftening vehicles. J Pharm Pharmacol, 43:382-387
60. 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.
61. 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, 11:109-112
62. Shiromani PK, Clair J. (2000). Statistical comparison of highshear versus low-shear granulation using a common formulation. Drug Dev Ind Pharm, 26:357-364
63. 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 controlledrelease matrix tablet containing HPMC and a high-dose, highly water-soluble drug. Pharm Technol, 20:80-92.
64. Visavarungroj N, Remon JP. (1991). Crosslinked starch as binding agent. III. Granulation of an insoluble filler. Int J Pharm, 69:43-51.
65. 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, 26:2213-2217
66. Markovic M, Takagi S, Chow LC. (2001). Formation of macroporous phosphate cements through the use of mannitol crystals. Key Eng Mater, 192:773-776