Scale Up and Technology Transfer of Pharmaceutical Suspensions

作者: Yashwant Pathak , Deepak Thassu

DOI: 10.1007/978-1-4419-1087-5_8

关键词:

摘要: Scaling up of suspension dosage form is considered a challenge as pharmaceutical suspensions are thermodynamically unstable. During the scale-up process, effect operational variables on dispersion and physical properties affecting overall attributes need systematic evaluation. Though scale process can be studied using dimensional analysis, mathematical modeling, computer simulation, most work in field manufacturing still depends empirical studies principles geometric similarities. Various aspects technology transfer, analytical (PAT) applications discussed.

参考文章(21)
Edward L. Paul, Michael Midler, Yongkui Sun, Mixing in the Fine Chemicals and Pharmaceutical Industries John Wiley & Sons, Inc.. pp. 1027- 1069 ,(2004) , 10.1002/0471451452.CH17
Herbert A. Lieberman, Martin M. Rieger, Gilbert S. Banker, Pharmaceutical Dosage Forms: Disperse Systems ,(1988)
E. Neil Lewis, Joseph W. Schoppelrei, Eunah Lee, Linda H. Kidder, Near‐Infrared Chemical Imaging as a Process Analytical Tool Process Analytical Technology. pp. 187- 225 ,(2007) , 10.1002/9780470988459.CH7
Hamsaraj Karanth, Vikram Subraya Shenoy, Rayasa Ramachandra Murthy, Industrially feasible alternative approaches in the manufacture of solid dispersions: a technical report. Aaps Pharmscitech. ,vol. 7, pp. 87- ,(2006) , 10.1208/PT070487
Ville Saarimaa, Anna Sundberg, Bjarne Holmbom, Angeles Blanco, Elena Fuente, Carlos Negro, Monitoring of Dissolved Air Flotation by Focused Beam Reflectance Measurement Industrial & Engineering Chemistry Research. ,vol. 45, pp. 7256- 7263 ,(2006) , 10.1021/IE060250+
J.M. Newton, S.R. Chapman, R.C. Rowe, The assessment of the scale-up performance of the extrusion/spheronisation process International Journal of Pharmaceutics. ,vol. 120, pp. 95- 99 ,(1995) , 10.1016/0378-5173(94)00425-5
Alex R. Heath, Phillip D. Fawell, Parisa A. Bahri, Jean D. Swift, Estimating Average Particle Size by Focused Beam Reflectance Measurement (FBRM) Particle & Particle Systems Characterization. ,vol. 19, pp. 84- 95 ,(2002) , 10.1002/1521-4117(200205)19:2<84::AID-PPSC84>3.0.CO;2-1
Niklas Laitinen, Osmo Antikainen, Jouko Yliruusi, Characterization of particle sizes in bulk pharmaceutical solids using digital image information AAPS PharmSciTech. ,vol. 4, pp. 383- 391 ,(2003) , 10.1208/PT040449