Advances in solid dosage form manufacturing technology

Philosophical Transactions of the Royal Society A: Mathematical, Physical and Engineering Sciences

Volumn 365, Issue 1861, 2007, Pages 2935-2949

  Andrews, Gavin P ^a  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

Drug delivery; Hot melt extrusion; Melt granulation

Indexed keywords

EID: 36549043420     PISSN: 1364503X     EISSN: None     Source Type: Journal    
DOI: 10.1098/rsta.2007.0014     Document Type: Article

References (53)

1. Aikten-Nichol, C., Zhang, F. & McGinity, J.W. 1996 Hot-melt extrusion of acrylic films. Pharm. Res. 13, 804-808, (doi:10.1023/A: 1016076306279). [CrossRef]
2. Aulton, M.E. 2002 Pharmaceutics: the science of dosage form design. London, UK: Churchill Livingstone.
3. Breitenbach, J. 2002 Melt extrusion: from process to drug delivery technology. Eur. J. Pharm. Biopharm. 54, 107-117, (doi:10.1016/S0939-6411(02)00061-9). [CrossRef]
4. Brittain, H.G. 2002 Effects of mechanical processing on phase composition. J. Pharm. Sci. 91, 1573-1580, (doi: 10.1002/jps.10115). [CrossRef]
5. Chokshi, R.J., Sandhu, H.K., Lyer, R.M., Shah, N.H., Malick, A. W. & Zia, H. 2005 Characterisation 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, 2463-2474, (doi:10.1002/jps.20385). [CrossRef]
6. Crawford, R.J. 1998 Plastics engineering. Oxford, UK: Butterworth-Heinemann.
7. Crowley, M., Zhang, F., Koleng, J. & McGinity, J.W. 2002 Stability of polyethylene oxide in matrix tablets prepared by hot melt extrusion. Biomaterials 23, 4241-4248, (doi: 10.1016/S0142-9612(02)00187-4). [CrossRef]
8. De Brabander, C., Vervaet, C., Fiermans, L. & Remon, J.P. 2000 Matrix mini-tablets based on starch/microcrystalline wax mixtures. Int. J. Pharm. 199, 195-203, (doi:10.1016/S0378-5173(00)00383-5). [CrossRef]
9. De Brabander, C., Vervaet, C. & Remon, J.P. 2003 Development and evaluation of sustained release mini-matrices prepared via hot-melt extrusion. J. Control. Release 89, 235-247, (doi:10.1016/S0168-3659(03)00075- 0). [CrossRef]
10. Desai, D.S., Rubitski, B.A., Varia, S.A. & Jain, N.B. 1996 Povidone and poloxamer-medlated degradation of hydrochlorothiazide in an antihypertensive combination tablet product. Int. J. Pharm. 142, 61-66, (doi: 10.1016/0378-5173(96)04645-5). [CrossRef]
11. Doolittle, A.K. 1954 The technology of solvents and plastlcisers. New York, NY: Wiley.
12. Fichtner, F., Rasmuson, A.C., Alander, E.M. & Alderborn, G. 2007 Effect of preparation method on compactability of paracetamol granules and agglomerates. Int. J. Pharm. 336, 148-158, (doi:10.1016/j.ijpharm. 2006.11.046). [CrossRef]
13. Follonier, N., Doelker, E. & Cole, E.T. 1994 Evaluation of hotmelt extrusion as a new technique for the production of polymerbased pellets for sustained release capsules containing high loading of freely soluble drugs. Drug Dev. Ind. Pharm. 20, 1323-1339.
14. Fung, K.Y. & Ng, K.M. 2003 Product-centred processing: pharmaceutical tablets and capsules. AICHE J. 49, 1193-1215, (doi:10.1002/aic.690490512). [CrossRef]
15. Gereg, G.W. & Cappola, M.L. 2002 Roller compaction feasability for new drug candidates. Laboratory to production scale. Pharm. Technol. 26, 14-23.
16. Hendriksen, B.A., Preston, M.S. & York, P. 1995 Processing effects on crystallinity of cephalexin: characterisation by vacuum microbalance. Int. J. Pharm. 118, 1-10, (doi:10.1016/0378-5173(94)00282-A). [CrossRef]
17. Hulsmann, S., Backensfeld, T., Keital, S. & Bodmeier, R. 2000 Melt extrusion-an alternative method for enhancing the dissolution rate of 17p-estradiol hemihydrate. Eur. J. Pharm. Biopharm. 49, 237-242, (doi:10.1016/S0939-6411(00)00077-1). [CrossRef]
18. Joins, E., Di Martino, P., Berneron, C., Guyot-Hermann, A.M. & Guyot, J.C. 1998 Compression behaviour of orthorhomblc paracetamol. Pharm. Res. 15, 1122-1130, (doi: 10.1023/A: 1011954800246). [CrossRef]
19. Kaerger, J.S., Edge, S. & Price, R. 2004 Influence of particle size and shape on flowability and compactibility of binary mixtures or paracetamol and microcrystalline cellulose. Eur. J. Pharm. Sci. 22, 173-179, (doi:10.1016/j.ejps.2004.03.005). [CrossRef]
20. Kidokoro, M., Haramlishl, Y., Sagasaki, S. &Yamamoto, Y. 2002 Application of fluidised hot-melt granulation (FHMG) for the preparation of granules for tableting. Drug Dev. Ind. Pharm. 28, 67-76, (doi:10.1081/DDC-120001487). [CrossRef]
21. Kidokoro, M., Sasaki, K., Haramiishi, Y. & Matahira, N. 2003 Effect of crystallisation behaviour of polyethylene glycol 6000 on the properties of granules prepared by fluidized hot-melt granulation (FHMG). Chem. Pharm. Bull. 51, 487-493, (doi:10.1248/cpb.51.487). [CrossRef]
22. Kojima, M. & Nakagami, H. 2001 Preparation of the controlled release matrix tablets of theophylline with micronized lowsubstituted hydroxpropyl cellulose by a fluidised hot-melt granulation method. S.T.P. Pharma Sci. 11, 145-150.
23. Kristensen, H. & Schaefer, T. 1987 Granulation - a review of pharmaceutical wet-granulation. Drug Dev. Ind. Pharm. 13, 803-872.
24. Krycer, I., Pope, D.G. & Hersey, J.A. 1980 An evaluation of tablet binding-agents. 1. Solution binders. Powder Technol. 34, 39-51, (doi:10.1016/0032-5910(83)87026-0). [CrossRef]
25. Laitinen, N., Antikainen, O., Rantanen, J. & Yiruusi, J. 2004 New perspectives for visual characterisation of pharmaceutical solids. J. Pharm. Sci. 93, 165-176, (doi:10.1002/jps.10529). [CrossRef]
26. Leuner, C. & Dressman, J. 2000 Improving drug solubility for oral delivery using solid dispersions. Eur. J. Pharm. Biopharm. 50, 47-60, (doi:10.1016/S0939-6411(00)00076-X). [CrossRef]
27. Li, L.C. & Peck, G.E. 1990 The effect of agglomeration methods on the micromeritic properties of a maltodextrin product, Maltrin 150. Drug Dev. Ind. Pharm. 16, 1491-1503.
28. Li, L.C., Abubaker, O. & Shao, Z.Z.J. 2006 Characterisation of Polyethylene oxide) as a drug carrier in hot-melt extrusion. Drug. Dev. Ind. Pharm. 32, 991-1002, (doi:10.1080/03639040600559057). [CrossRef]
29. Lieberman, H.A. & Lachman, L. 1981 Pharmaceutical dosage forms: tablets. New York, NY: Marcel Dekker.
30. Liu, J., Zhang, F. & McGinity, J.W. 2001 Properties of lipophilic matrix tablets containing phenylpropanolamine hydrochloride prepared by hot-melt extrusion. Eur. J. Pharm. Biopharm. 52, 181-190, (doi:10.1016/S0939-6411(01)00162-X). [CrossRef]
31. Malkowska, S. & Khan, K.A. 1983 Effect of re-compression on the properties of tablets prepared by dry granulation. Drug Dev. Ind. Pharm. 9, 331-347.
32. McGinity, J. W. 2004 Hot-melt extrusion as a pharmaceutical process. AAPS News Mag. 21-25.
33. Mehuys, E., Vervaet, C., Gielen, I., Van Bree, H. & Remon, J.P. 2004 In vitro and In vivo evaluation of a matrix-in-cylinder system for sustained drug delivery. J. Control. Release 96, 261-271, (dol:10.1016/j.jconrel.2004.01.023). [CrossRef]
34. Patterson, J.E., James, M.B., Forster, A.H., Lancaster, R.W., Butler, J.M. & Rades, T. 2007 Preparation of glass solutions of three poorly water soluble drugs by spray drying, melt extrusion and ball milling. Int. J. Pharm. 336, 22-34, (dol:10.1016/j.rjpharm.2006.11.030). [CrossRef]
35. Prodduturi, S., Manek, R.V., Kolling, W.M., Stodghill, S.P. & Repka, M.A. 2005 Solid-state stability and characterisation of hot-melt extruded poly(ethylene oxide) films. J. Pharm. Sci. 94, 2232-2245, (doi:10.1002/jps.20437). [CrossRef]
36. Repka, M.A. & McGinity, J.W. 2000 Influence of vitamin E TPGS on the properties hydrophilic films produced by hot melt extrusion. Int. J. Pharm. 202, 63-70, (doi:10.1016/S0378-5173(00)00418-X). [CrossRef]
37. Schaefer, T., Holm, P. & Kristen, H.G. 1990 Melt granulation in a laboratory scale high-shear mixer. Drug Dev. Ind. Pharm. 16, 1249-1277.
38. Seo, A., Holm, P. & Kristen, H.G. 2002 Effects of droplet size and type of binder on the agglomerate growth mechanisms by melt agglomeration in a fluidised bed. Eur. J. Pharm. Sci. 16, 95-105, (doi:10.1016/S0928-0987(02)00086-6). [CrossRef]
39. Six, K. et al. 2005 Clinical study of solid dispersions of itraconazole prepared by hot-stage extrusion. Eur. J. Pharm. Sci. 24, 179-186, (doi:10.1016/j.ejps.2004.10.005). [CrossRef]
40. Sun, C.C. & Grant, D.J.W. 2001 Effects of intial particle size on the tabletting properties of I -lysine monohydrochloride dihydrate powder. Int. J. Pharm. 215, 221-228, (doi:10.1016/S0378-5173(00)00701-8). [CrossRef]
41. Tan, H.S., Salman, A.D. & Hounslow, M.J. 2004 Kinetics of fluidised bed melt granulation-IV. Selecting the breakage model. Powder Technol. 143, 65-83, (doi:10.1016/j.powtec.2004.05.004). [CrossRef]
42. Tan, H.S., Salman, A.D. & Hounslow, M.J. 2005 Kinetics of fluidised bed melt granulation V: simultaneous modelling of aggregation and breakage. Chem. Eng. Sci. 60, 3847-3866, (doi:10.1016/j.ces.2005.02.008). [CrossRef]
43. Tan, H.S., Salman, A.D. & Hounslow, M.J. 2006 Kinetics of fluidised bed melt granulation I: the effect of process variables. Chem. Eng. Sci. 61, 1585-1601, (doi: 10.1016/j.ces.2005.09.012). [CrossRef]
44. Tantry, J.S., Tank, J. & Suryanarayanan, R. 2007 Processinginduced phase transitions of theophylline-Implications on the dissolution of theophylline tablets. J. Pharm. Sci. 96, 1434-1444, (doi:10.1002/ips.20746). [CrossRef]
45. Verreck, G. et al. 2005 The effect of pressurised carbon dioxide as a temporary plastlciser and foaming agent on the hot stage extrusion process and extrudate properties of solid dispersions of itraconazole with PVP-VA 64. Eur. J. Pharm. Sci. 26, 349-358, (doi:10.1016/j.ejps.2005.07.006). [CrossRef]
46. Vervaet, C. & Remon, J.P. 2005 Continuous granulation in the pharmaceutical industry. Chem. Eng. Sci. 60, 3949-3957, (doi:10.1016/j.ces.2005.02.028). [CrossRef]
47. Walker, G.M., Andrews, G.P. & Jones, D.S. 2006 Effect of process parameters on the melt granulation of pharmaceutical powders. Powder Technol. 165, 161-166, (doi:10.1016/j.powtec.2006.03.024). [CrossRef]
48. Walker, G.M., Bell, S.E.J., Andrews, G.P. & Jones, D.S. 2007 Comelt fluidised bed granulation of pharmaceutical powders: improvements in drug bioavailability. Chem. Eng. Sci. 62, 451-462, (doi:10.1016/j.ces. 2006.08.074). [CrossRef]
49. Walker, G.M., Bell, S.E.J., Vann, M., Jones, D.S. & Andrews, G. P. 2007 Fluidised bed characterisation using Raman spectroscopy: applications to pharmaceutical processing. Chem. Eng. Sci. 62, 3832-3838, (doi:10.1016/j.ces.2007.04.017). [CrossRef]
50. Wardrop, J., Law, D., Qiu, Y., Engh, K., Faitsch, L. & Ling, C. 2005 Influence of solid phase and formulation processing on the stability of Abbott-232 tablet formulations. J. Pharm. Sci. 95, 2380-2392, (doi:10.1002/jps.20679). [CrossRef]
51. Yoshika, M., Hancock, B. & Zografi, G. 1995 Inhibition of indomethacin crystallisation in poly(vinylpyrrolidone) coprecipitates. J. Pharm. Sci. 84, 983-986, (doi:10.1002/jps.2600840814). [CrossRef]
52. Zhang, F. & McGinity, J.W. 1999 Properties of sustained-release tablets prepared by hot melt extrusion. Pharm. Dev. Technol. 4, 241-250, (dol:10.1081/PDT-100101358). [CrossRef]
53. Zhang, G.G.Z., Law, D., Schmitt, E.A. & Qiu, Y. 2004 Phase transformation considerations during process development and manufacture of solid oral dosage forms. Adv. Drug Deliv. Rev. 56, 371-390, (doi: 10.1016/j.addr.2003.10.009). [CrossRef]