References
- 1. T. Schæfer, P. Holm and H. G. Kristensen, Melt granulation in a laboratory scale high shear mixer, Drug Dev. Ind. Pharm, 16 (1990) 1249-1277; DOI: 10.3109/03639049009115960.
- 2. J. Kowalski, O. Kalb, Y. M. Joshi and A. T. M. Serajuddin, Application of melt granulation technology to enhance stability of a moisture sensitive immediate-release drug product, Int. J. Pharm. 381 (2009) 56-61; DOI: 10.1016/j.ijpharm.2009.05.043.
- 3. P. W. S. Heng and T. W. Wong, Melt Processes for Oral Solid Dosage Forms, in Encyclopedia of Pharmaceutical Technology (Ed. J. Swarbrick), 3rd ed., Taylor & Francis Group, New York 2006, pp. 2257-2261; DOI: 10.1081/E-EPT-120018221.
- 4. T. Abberger, Influence of binder properties, method of addition, powder type and operating conditions on fluid-bed melt granulation and resulting tablet properties, Pharmazie 56 (2001) 949-952; DOI: 10.1016/0006-2952(75)90001-5.
- 5. M. Kidokoro, Y. Haramiishi, S. Sagasaki and Y. Yamamoto, Application of fluidised hot-melt granulation (FHMG) for the preparation of granules for tableting, Drug Dev. Ind. Pharm. 28 (2002) 67-76; DOI: 10.1081/DDC-120001487.
- 6. A. Seo, P. Holm and T. Schaefer, 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 (2002) 95-105; DOI: 10.1016/S0928-0987(02)00086-6.
- 7. A. Seo, P. Holm, H. G. Kristensen and T. Schaefer, The preparation of agglomerates containing solid dispersions of diazepam by melt agglomeration in a high shear mixer, Int. J. Pharm. 259 (2003) 161-171; DOI: 10.1016/S0378-5173(03)00228-X.
- 8. G. M. Walker, C. R. Holland, M. M. N. Ahmad and D. Q. M. Craig, Influence of process parameters on fluidized hot-melt granulation and tablet pressing of pharmaceutical powders, Chem. Eng. Sci. 60 (2005) 3867-3877; DOI: 10.1016/j.ces.2005.02.007.
- 9. G. Walker, S. Bell, M. Vann, H. Zhai, D. Jones and G. Andrews, Pharmaceutically engineering powders using FHMG: The effects of process parameters and formulation variables, Chem. Eng. Res. Des. 85 (2007) 981-986; DOI: 10.1205/cherd06186.
- 10. H. Zhai, S. Li, D. S. Jones, G. M. Walker and G. P. Andrews, The effect of the binder size and viscosity on agglomerate growth in fluidised hot melt granulation, Chem. Eng. J. 164 (2010) 275-284; DOI: 10.1016/j.cej.2010.08.056.
- 11. FDA Guidance for Industry, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, Center for Drug Evaluation and Research (CDER), Rockville, USA 2004.
- 12. G. A. Lewis, Optimization Methods, in Encyclopedia of Pharmaceutical Technology (Ed. J. Swarbrick), 3rd ed., Taylor & Francis Group, New York 2006, pp. 2452-2467; DOI: 10.1081/E-EPT-100200031.
- 13. G. Betz, H. Leuenberger and D. M. Jones, Scale-up in the Field of Granulation and Drying, in Pharmaceutical Process Scale-up (Ed. M. Levin), 2nd ed., Marcel Dekker, New York 2005, pp. 199-236; DOI: 10.1201/9781420026658.ch8.
- 14. D. M. Parikh, Batch Size Increase in Fluid Bed Granulation, in Pharmaceutical Process Scale-up (Ed. M. Levin), 2nd ed., Marcel Dekker, New York 2005, pp. 267-324; DOI: 10.1201/9781420026658.ch10.
- 15. A. Faure, P. Yorkb and R. C. Rowe, Process control and scale-up of pharmaceutical wet granulation processes: a review, Eur. J. Pharm. Biopharm. 52 (2001) 269-277; DOI: 10.1016/S0939-6411(01)00184-9.
- 16. B. Rambali, L. Baert and D. L. Massart, Scaling up of the fluidized bed granulation process, Int. J. Pharm. 252 (2003) 197-206; DOI: 10.1016/S0378-5173(02)00646-4.
- 17. J. Bouffard, H. Dumont, H. Bertrand and R. Legros, Optimization and scale-up of a fluid bed tangential spray rotogranulation process, Int. J. Pharm. 335 (2007) 54-62; DOI: 10.1016/j.ijpharm.2006.11.022.
- 18. D. Teslić, Gas Distribution Plate Intended for Use in Devices for Treating Solid Particles, WIPO Pat. WO2011031244, 17 Mar 2011.
- 19. S. Kukec, R. Dreu, T. Vrbanec, S. Srčič and F. Vrečer, Characterization of agglomerated carvedilol by hot-melt processes in a fluid bed and high shear granulator, Int. J. Pharm. 430 (2012) 74-85; DOI: 10.1016/j.ijpharm.2012.03.041.
- 20. O. Planinšek, B. Kovačič and F. Vrečer, Carvedilol dissolution improvement by preparation of solid dispersions with porous silica, Int. J. Pharm. 406 (2011) 41-48; DOI: 10.1016/j.ijpharm.2010.12.035.
- 21. M. A. Ansari and F. Stepanek, Formation of hollow core granules by fluid bed in situ melt granulation: modelling and experiments, Int. J. Pharm. 321 (2006) 108-116; DOI: 10.1016/j.ijpharm.2006.05.012.
- 22. H. Zhai, S. Li, G. Andrews, D. Jones, S. Bell and G. Walker, Nucleation and growth in fluidised hot melt granulation, Powder Technol. 189 (2009) 230-237; DOI: 10.1016/j.powtec.2008.04.021.
- 23. N. Passerini, B. Albertini, M. L. Gonzalez-Rodriguez, C. Cavallari and L. Rodiguez, Preparation and characterization of ibuprofen-poloxamer 188 granules obtained by melt granulation, Eur. J. Pharm. Sci. 15 (2002) 71-78; DOI: 10.1016/S0928-0987(01)00210-X.
- 24. N. Passerini, B. Albertini, B. Perissuti and L. Rodiguez, Evaluation of melt granulation and ultrasonic spray congealing as techniques to enhance the dissolution of praziquantel, Int. J. Pharm. 318 (2006) 92-102; DOI: 10.1016/j.ijpharm.2006.03.028.
- 25. P. Beyer and E. Reinholz, Thermodynamically Stable Modification of 1-(4-Carbazolyloxy)-3-[2-(2-methoxyphenoxy)ethylamino]-2-propanole, Process for its Preparation and Pharmaceutical Compositions Containing it, European Pat. 0,893,440, 27 Jan 1999.