Formulation design for optimal high-shear wet granulation using on-line torque measurements

International Journal of Pharmaceutics

Volumn 387, Issue 1-2, 2010, Pages 48-55

  Cavinato, Mauro ^a   Bresciani, Massimo ^b   Machin, Marianna ^b   Bellazzi, Guido ^b   Canu, Paolo ^a   Santomaso, Andrea C ^a  

^a UNIVERSITY OF PADOVA   (Italy)

^b GSK   (Italy)

Author keywords

Glass transition; High shear mixer; Water uptake; Wet granulation

Indexed keywords

DRUG; HYDROXYPROPYLMETHYLCELLULOSE; POVIDONE;

ARTICLE; CONTROLLED STUDY; DRUG DESIGN; DRUG FORMULATION; DRUG GRANULATION; GLASS TRANSITION TEMPERATURE; HUMIDITY; ONLINE MONITORING; PARTICLE SIZE; PRIORITY JOURNAL; PROCESS OPTIMIZATION; QUANTITATIVE ANALYSIS; SHEAR STRESS; TORQUE; WETTABILITY;

CHEMISTRY, PHARMACEUTICAL; EXCIPIENTS; HUMIDITY; PARTICLE SIZE; TECHNOLOGY, PHARMACEUTICAL; TORQUE; TRANSITION TEMPERATURE; WETTABILITY;

EID: 77649186273     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.11.032     Document Type: Article

References (21)

1. Betz G., Bürgin P.J., Leuenberger H. Power consumption measurement and temperature recording during granulation. Int. J. Pharm. 2004, 272:137-149.
2. Briens L., Daniher D., Tallevi A. Monitoring high-shear granulation using sound and vibration measurements. Int. J. Pharm. 2007, 331:54-60.
3. Daniher D., Briens L., Tallevi A. End-point detection in high-shear granulation using sound and vibration signal analysis. Powder Technol. 2008, 181:130-136.
4. Ennis B.J. Theory of granulation: an engineering perspective. Handbook of Pharmaceutical Granulation Technology 2006, Taylor and Francis Group, New York (U.S.A.). 2nd ed. D.M. Parikh (Ed.).
5. Faure A., York P., Rowe R.C. Process control and scale-up of pharmaceutical wet granulation processes: a review. Eur. J. Pharm. Biopharm. 2001, 52:269-277.
6. Gokhale R., Sun Y., Shukla A.J. High-shear granulation. Handbook of Pharmaceutical Granulation Technology 2006, Taylor and Francis Group, New York (U.S.A.). 2nd ed. D.M. Parikh (Ed.).
7. Hancock B.C., Zografi G. The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids. Pharm. Res. 1994, 11.
8. Holm P. High shear mixer granulators. Handbook of Pharmaceutical Granulation Technology 1997, Taylor and Francis Group, New York (U.S.A.). 1st ed. D.M. Parikh (Ed.).
9. Knight P.C., Seville J.P.K., Wellm A.B., Instone T. Prediction of impeller torque in high shear powder mixers. Chem. Eng. Sci. 2001, 56:4457-4471.
10. Landin M., Rowe R.C., York P. Characterization of wet powder masses with a mixer torque rheometer. 3. Nonlinear effects of shaft speed and sample weight. J. Pharm. Sci. 1995, 84(5):557-560.
11. Landin M., York P., Cliff M.J., Rowe R.C., Wigmore A.J. The effect of batch size on scale-up of pharmaceutical granulation in a fixed bowl mixer-granulator. Int. J. Pharm. 1996, 134:243-246.
12. Leuenberger H. Granulation, new techniques. Pharm. Acta Helv. 1982, 57:72-82.
13. Leuenberger H., Puchkov M., Krausbauer E., Betz G. Manufacturing pharmaceutical granules: Is the granulation end-point a myth?. Powder Technol. 2009, 189:141-148.
14. Litster J.D., Ennis B.J. Size reduction and size enlargement. Perry's Chemical Engineers' Handbook 1999, McGraw-Hill Companies, New York (U.S.A.). R.H. Perry, D.W. Green (Eds.).
15. Mort P.R. Scale-up of binder agglomeration processes. Powder Technol. 2005, 150:86-103.
16. Palzer P. The effect of glass transition on the desired and undesired agglomeration of amorphous food powders. Chem. Eng. Sci. 2005, 60:3959-3968.
17. Ritala M., Holm P., Schaefer T., Kristensen H.G. Influence of liquid bonding strength on power consumption during granulation in a high shear mixer. Drug Dev. Ind. Pharm. 1988, 14:1041-1060.
18. Tardos G.I., Kahn M., Mort P. Critical parameters and limiting conditions in binder granulation of fine powders. Powder Technol. 1997, 94:245-258.
19. Tardos G.I., Hapgood K.P., Ipadeola O.O., Michaels J.N. Stress measurements in high shear granulators using calibrated 'test' particles: application to scale-up. Powder Technol. 2004, 140:217-227.
20. Tardos G.I. Wet-granulation research with application to scale-up. China Particuology 2005, 3:191-195.
21. Wildeboer W.J., Litster J.D., Cameron I.T. Modelling nucleation in wet granulation. Chem. Eng. Sci. 2005, 60:3751-3761.