Development of 400 μm Pellets by Extrusion-Spheronization: Application with Gelucire 50/02 to Produce a "Sprinkle" Form

Drug Development and Industrial Pharmacy

Volumn 30, Issue 1, 2004, Pages 43-51

  Flament, M P ^a   Dupont, G ^a   Leterme, P ^a   Farah, N ^b   Gayot, A ^a  

^a UNIV LILLE   (France)

^b NONE

Author keywords

400 m pellets; Active drug; Extrusion spheronization; Gelucire

Indexed keywords

AMPHOPHILE; GELUCIRE; GELUCIRE 50 02; UNCLASSIFIED DRUG; DODECYL SULFATE SODIUM; EXCIPIENT; FAT; GELUCIRE 50-02; MICROSPHERE; OIL; THEOPHYLLINE;

ARTICLE; DRUG FORMULATION; DRUG SOLUBILITY; DRY POWDER; EQUIPMENT DESIGN; GEOMETRY; MICROSCOPY; PARTICLE SIZE; PELLET EXTRUSION; PLASTICITY; SPHERONIZATION; CHEMISTRY; INSTRUMENTATION; METHODOLOGY; SOLUBILITY;

DRUG COMPOUNDING; EXCIPIENTS; FATS; MICROSPHERES; OILS; PARTICLE SIZE; SODIUM DODECYL SULFATE; SOLUBILITY; THEOPHYLLINE;

EID: 1242276153     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.1081/DDC-120027510     Document Type: Article

References (23)

1. Gayot, A.; Lafaille, P.; Leterme, P.; Baume, B.; Traisnel, M. Essais de fabrication de granules et globules inertes à usage homéopathique par extrusion ou extrusion-découpe et sphéronisation. STP Pharma 1985, 1 (3), 189-193.
2. Mouton, R.; Gayot, A. Evaluation de l'influence des conditions opératoires d'un extrudeur à cylindres et d'un sphéroniseur. STP Pharma 1988, 4 (8), 648-655.
3. Gayot, A.; Leterme, P. La technique d'extrusionsphéronisation. Acta Technol. Legis Medicam. 1990, 1 (2), 81-100.
4. Newton, J.M. The preparation of spherical granules by extrusion/spheronization. STP Pharma 1990, 6 (6), 396-398.
5. Follonier, N.; Doelker, E. Biopharmaceutical comparison of oral multiple unit and single unit sustained release dosage form. STP Pharma Sci. October 1992, 2 (2), 141-158.
6. Newton, J.M.; Chow, A.K.; Jeewa, K.B. The effect of excipient source on spherical granules made by extrusion/spheronization. Pharm. Technol. Int. October 1992, 52-58.
7. Newton, J.M.; Chapman, J.R.; Rowe, R.C. 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.
8. Raines, C.L.; Newton, J.M. The extrusion rheology of various grades of microcrystalline cellulose. J. Pharm. Pharmacol. 1987, 39, 90.
9. Kjellman, N.I.M.; Croner, S.; Leijon, I.; Friber, G.K.; Thuresson, S.O. Theophylline pharmacokinetics in children, comparing sustained release spheres (Theo-Dur sprinkle) with elixir. Eur. J. Pediatr. 1988, 148, 278-280.
10. Carrigan, P.J.; Bunker, D.R.; Cavanaugh, J.H.; Lamm, J.E.; Cloyd, J.C. Absorption characteristics of a new valproate formulation: divalproex sodium-coated particles in capsules/Depakote sprinkle. J. Clin. Pharmacol. 1990, 30 (8), 743-747.
11. Malinowski, H.J.; Smith, W.E. Use of factorial design to evaluate granulations prepared by spheronization. J. Pharm. Sci. October 1975, 64 (10), 1688-1692.
12. Hileman, G.A.; Goskonda, S.R.; Spalitto, A.; Upadrashta, S.M. A factorial approach to high dose product development by an extrusion-spheronization process. Drug Dev. Ind. Pharm. 1993, 19 (4), 483-491.
13. Harrison, P.J.; Newton, J.M.; Rowe, R.C. The characterisation of wet powder masses suitable for extrusion/spheronization. J. Pharm. Pharmacol. 1985a, 37, 686-691.
14. Harrison, P.J.; Newton, J.M.; Rowe, R.C. The application of capillary rheometry to the extrusion of wet powder masses. Int. J. Pharm. 1987, 35, 235-242.
15. Bianchini, R.; Vecchio, C. Oral controlled release optimization of pellets prepared by extrusion-spheronization processing. II. Pharmaco 1989, 44 (6), 645-654.
16. Pinto, J.F.; Buckton, G.; Newton, J.M. The influence of four selected processing and formulation factors on the production of spheres by extrusion and spheronization. Int. J. Pharm. 1992, 83, 187-196.
17. Goodhart, F.; Ronald Draper, J.; Ninger, F.C. Design and use of a laboratory extruder for pharmaceutical granulations. J. Pharm. Sci. January 1973, 62 (1), 133-136.
18. Chapman, S.R.; Rowe, R.C.; Harrison, P.J.; Newton, J.M. The influence of process variables on the density of granules produced by extrusion-spheronization. 4e Congrès Int. Technol. Pharm. APGI Paris June 1986, 9-14.
19. Benbow, J.J.; Oxley, E.W.; Bridgwater, J. The extrusion mechanics of pastes. The influence of paste formulation on extrusion parameters. Chem. Eng. Sci. 1987, 42 (9), 2151-2162.
20. Vervaet, C.; Baert, L.; Risha, P.; Remon, J.P. The influence of the extrusion screen on pellet quality using an instrumented basket extruder. Int. J. Pharm. 1994, 107, 29-39.
21. Harrison, P.J.; Newton, J.M.; Rowe, R.C. Flow defects in wet powder mass extrusion. J. Pharm. Pharmacol. 1985b, 37, 81-83.
22. Dietrich, R. Food technology transfers to pellet production. Manuf. Chem. August 1989, 30-33.
23. Dupont, G.; Flament, M.P.; Leterme, P.; Farah, N.; Gayot, A. Developing of a study method for producing 400 μm spheroids. Int. J. Pharm. 2002, 247, 159-165.