Extrusion/spheronization

Pharmaceutical Extrusion Technology

Volumn , Issue , 2003, Pages 277-322

  Erkoboni, David F ^a  

^a FMC CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84905458717     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (64)

1. Nakahara. U.S. Patent 3,277,520, October 1966.
2. Conine JW, Hadley HR. Preparation of small solid pharmaceutical spheres. Drug Cosmet Ind 1970; 106:38-41.
3. Reynolds AD. A new technique for the production of spherical particles. Manuf Chem Aerosol News 1970; 41:40-43.
4. Bechgaard H, Hagermann NG. Controlled-release multi-units and single unit doses. A literature review. Drug Dev Ind Pharm 1978; 4:53-67.
5. Newton JM. The preparation of spherical granules by extrusion/spheronization. STP Pharma 1990; 6:396-398.
6. Jalal IM, Malinowski HJ, Smith WE. Tablet granulations composed of sphericalshaped particles. J Pharm Sci 1972; 61:1466-1468.
7. Devereus JE, Newton JM, Short MB. The influence of density on the gastrointestinal transit of pellets. J Pharm Pharmacol 1990; 42:500-501.
8. Clarke GM, Newton JM, Short MB. Comparative gastrointestinal transit of pellet systems of varying density. Int J Pharm 1995; 114:1-11.
9. Woodruff CW, Nuessle NO. Effect of processing variables on particles obtained by extrusion-spheronization. J Pharm Sci 1972; 61:787-790.
10. Schwartz JP, Nguyen NH, Schnaare RL. Compaction studies on beads: compression and consolidation parameters. Drug Dev Ind Pharm 1994; 20:3105-3129.
11. Millili GP, Schwartz JB. The strength of microcrystalline cellulose pellets: the effect of granulating with water/ethanol mixtures. Drug Dev Ind Pharm 1990; 16:1411-1426.
12. Malinowski HJ, Smith WE. Effect of spheronization process variables on selected tablet properties. J Pharm Sci 1974; 63:285-288.
13. Malinowski HJ, Smith WE. Use of factorial design to evaluate granulations prepared by spheronization. J Pharm Sci 1975; 64:1688-1692.
14. Erkoboni DF, Fiore SA, Wheatley TA, Davan T. The effect of various process and formulation variables on the quality of spheres produced by extrusion/spheronization. Poster presentation, AAPS National Meeting, 1991.
15. Chariot M, Francès J, Lewis GA, Mathieu D, Phan Tan Luu R, Stevens HNE. A factorial approach to process variables of extrusion-spheronization of wet powder masses. Drug Dev Ind Pharm 1987; 13:1639-1649.
16. Hileman GA, Goskonda SR, Spalitto AJ, Upadrashta SM. Response surface optimization of high dose pellets by extrusion and spheronization. Int J Pharm 1993; 100:71-79.
17. Goskonda SR, Hileman GA, Upadrashta SM. Development of matrix controlled release beads by Extrusion-Spheronization technology using a statistical screening design. Drug Dev Ind Pharm 1994; 20:279-292.
18. O’Connor RE, Holinez J, Schwartz JB. Spheronization: I. Processing and evaluation of spheres prepared from commercially available excipients. Am J Pharm 1984; 156:80-87.
19. Ojile JE, Macfarlane CB, Selkirk AB. Drug distribution during massing and its effect on dose uniformity in granules. Int J Pharm 1982; 10:99-107.
20. Hellen L, Yliruusi J, Merkku P, Kristoffersson E. Process variables of instant granulator and spheronizer: I. Physical properties of granules, extrudate and pellets. Int J Pharm 1993; 96:197-204.
21. Kleinebudde P, Lindner H. Experiments with a twin-screw extruder using a single-step granulation/extrusion process. Int J Pharm 1993; 94:49-58.
22. Lindberg NO, Tufvesson C, Holm P, Olbjer L. Extrusion of an effervescent granulation with a twin-screw extruder, Baker Perkins MPF 50 D. Influence in intragranular porosity and liquid saturation. Drug Dev Ind Pharm 1988; 14:1791-1798.
23. Harrison PJ, Newton JM, Rowe RC. The characterization of wet powder masses suitable for extrusion/spheronization. J Pharm Pharmacol 1985; 37:686-691.
24. Parker MD, Rowe RC, Upjohn NG. Mixer Torque Rheometry: a method of quantifying the consistency of wet granulations. Pharm Technol Int 1990; 2:50-62.
25. Rowe RC, Parker MD. Mixer Torque Rheometry: an update. Pharm Technol Int 1994; 3:74-82.
26. Baert L, Remon JP, Knight P, Newton JM. A comparison between the extrusion forces and sphere quality of a gravity feed extruder and a ram extruder. Int J Pharm 1992; 86:187-192.
27. Gamlen MJ. Continuous extrusion using a Baker Perkins MPF 50 D (multipurpose) extruder. Drug Dev Ind Pharm 1986; 12:1701-1713.
28. Baert L, Fanara D, De Baets P, Remon JP. Instrumentation of a gravity feed extruder and the influence of the composition of binary and tertiary mixtures on the extrusion forces. J Pharm Pharmacol 1991; 43:745-749.
29. Ku CC, Joshi YM, Bergum JS, Jain NB. Bead manufacture by extrusion/spheronization—a statistical design for process optimization. Drug Dev Ind Pharm 1993; 19:1505-1519.
30. Rowe RC. Spheronization: a novel pill-making process? Pharm Int 1985; 6:119-123.
31. Harrison PJ, Newton JM, Rowe RC. The application of capillary rheometry to the extrusion of wet masses. J Pharm 1987; 35:235-242.
32. Hicks DC, Freese HL. In: Ghebre-Sellassie I, ed. Extrusion and Spheronization Equipment, Chapter 4. Pharmaceutical Pelletization Technology. New York: Marcel Dekker, 1989:71-100.
33. Harrison PJ, Newton JM, Rowe RC. Flow defects in wet powder masses. J Pharm Pharmacol 1984; 37:81-83.
34. Harrison PJ, Newton JM, Rowe RC. Convergent flow analysis in the extrusion of wet powder masses. J Pharm Pharmacol 1984; 37:81-83.
35. Pinto JF, Buckton G, Newton JM. The influence of four selected processing and formulation factors on the production of spheres by extrusion and spheroniza-tion. Int J Pharm 1992; 83:187-196.
36. Helléin L, Ritala M, Yliruusi J, Palmroos P, Kristoffersson E. Process variables of the radial screen extruder: I. Production capacity of the extruder and the properties of the extrudate. J Pharm Tech Int 1992; 4:50-60.
37. Vervaet C, Baert L, Risha PA, Remon JP. The influence of the extrusion screen on pellet quality using an instrumented basket extruder. Int J Pharm 1994; 107:29-39.
38. Baert L, Remon JP, Elbers JAC, Van Bommel EMG. Comparison between a gravity feed extruder and a twin screw extruder. Int J Pharm 1993; 99:7-12.
39. Vervaet C, Remon JP. Influence of impeller design, method of screen performance and perforation geometry on the quality of pellets made by extrusion-spheronisation. Int J Pharm 1996; 133:29-37.
40. Shah R, Kabadi M, Pope DG, Augsberger LL. Physico-mechanical characterization of the extrusion/spheronization process: Part I. Instrumentation of the extruder. Pharm Res 1994; 11:355-360.
41. O’Connor RE, Schwartz JB. In: Ghebre-Sellassie I, ed. Extrusion and Spheronization Technology, Chapter 9. Pharmaceutical Pelletization Technology. New York: Marcel Dekker, 1989:187-216.
42. Hasznos L, Langer I, Gyarmathy M. Some factors influencing pellet characteristics made by an extrusion/spheronization process: Part I. Effects on size characteristics and moisture content decrease of pellets. Drug Dev Ind Pharm 1992; 18:409-437.
43. Hileman GA, Goskonda SR, Spalitto AJ, Upadrashta SM. A factorial approach to high dose product development by an extrusion/spheronization process. Drug Dev Ind Pharm 1993; 19:483-491.
44. Thoma K, Ziegler I. Investigations on the influence of the type of extruder for pelletization by extrusion-spheronization: I. Sphere characteristics. Drug Dev Ind Pharm 1998; 24:413-422.
45. Thoma K, Ziegler I. Investigations on the influence of the type of extruder for pelletization by extrusion-spheronization: II. Extrusion behavior of formulations. Drug Dev Ind Pharm 1998; 24:401-411.
46. Baert L, Remon J. Influence of amount of granulating liquid on the drug release rate from pellets made by extrusion spheronization. Int J Pharm 1993; 95:135-141.
47. Wan LSC, Heng PWS, Liew CV. Spheronization conditions on spheroid shape and size. Int J Pharm 1993; 96:59-65.
48. Newton JM, Chapman SR, Rowe RC. The influence of process variables on the preparation and properties of spherical granules by the process of extrusion and spheronization. Int J Pharm 1995; 120:101-109.
49. Bataille B, Ligarski K, Jacob M, Thomas C, Duru C. Study of the influence of spheronization and drying condition on the physico-mechanical properties of neutral spheroids containing Avicel PH-101 and lactose. Drug Dev Ind Pharm 1993; 19:653-671.
50. Hellén L, Yliruusi J. Process variables of instant granulator and spheronizer: III. Shape and shape distribution of pellets. Int J Pharm 1993; 96:217-223.
51. Dyer AM, Khan KA, Aulton ME. Effect of the drying method on the mechanical and drug release properties of pellets prepared by extrusion. Drug Dev Ind Pharm 1994; 20:3045-3068.
52. O’Connor RE, Schwartz JB. Spheronization: II. Drug release from drug-diluent mixtures. Drug Dev Ind Pharm 1985; 11:1837-1857.
53. Millili GP, Wigent RJ, Schwartz JB. Autohesion in pharmaceutical solids. Drug Dev Ind Pharm 1990; 16:2383-2407.
54. Lustig-Gustafsson C, Kaur Johal H, Podczeck F, Newton JM. The influence of water content and drug solubility on the formulation of pellets by extrusion and spheronisation. Eur J Pharm Sci 1999; 8:147-152.
55. Newton JM, Chow AK, Jeewa KB. The effect of excipient source on spherical granules made by extrusion/spheronization. Pharm Tech Int 1992; 10:52-58.
56. Funck JAB, Schwartz JB, Reilly WJ, Ghali ES. Binder effectiveness for beads with high drug levels. Drug Dev Ind Pharm 1991; 17:1143-1156.
57. Linder H, Kleinebudde P. Use of powdered cellulose for the production of pellets by extrusion/spheronization. J Pharm Pharmacol 1994; 46:2-7.
58. Fielden KE, Newton JM, Rowe RC. The influence of lactose particle size on the spheronization of extrudate processed by a ram extruder. Int J Pharm 1992; 81:205-224.
59. Mesiha MS, Vallés J. A screening study of lubricants in wet powder masses suitable for extrusion-spheronization. Drug Dev Ind Pharm 1993; 19:943-959.
60. Law MFL, Deast PB. Use of hydrophilic polymers with microcrystalline cellulose to improve extrusion-spheronization. Eur J Pharm Biopharm 1998; 45:57-65.
61. Kleinbudde P. Shrinking and swelling properties of pellets containing microcrystalline cellulose and low substituted hydroxypropylcellulose: I. Shrinking properties. Int J Pharm 1994; 109:209-219.
62. Kleinbudde P. Shrinking and swelling properties of pellets containing microcrystalline cellulose and low substituted hydroxypropylcellulose: II. Swelling properties. Int J Pharm 1994; 109:221-227.
63. Rowe R, Iles C. Spheronization systems downsized for research. Manuf Chem 1995; 11:35-37.
64. Wan LS, Heng PW, Liew CV. Spheronization conditions on shape and size. Int J Pharm 1993; 96:59.