PMID- 20554021
OWN - NLM
STAT- MEDLINE
DCOM- 20101207
LR  - 20191210
IS  - 1873-3441 (Electronic)
IS  - 0939-6411 (Linking)
VI  - 76
IP  - 1
DP  - 2010 Sep
TI  - Evaluation of in-line spatial filter velocimetry as PAT monitoring tool for 
      particle growth during fluid bed granulation.
PG  - 138-46
LID - 10.1016/j.ejpb.2010.06.001 [doi]
AB  - In this study, the feasibility of spatial filter velocimetry (SFV) as process 
      analytical technology tool for the in-line monitoring of the particle size 
      distribution during top spray fluidized bed granulation was examined. The 
      influence of several process (inlet air temperature during spraying and drying) 
      and formulation variables (HPMC and Tween 20 concentration) upon the particle 
      size distribution during processing, and the end product particle size 
      distribution, tapped density and Hausner ratio was examined using a design of 
      experiments (DOE) (2-level full factorial design, 19 experiments). The trend in 
      end granule particle size distributions of all DOE batches measured with in-line 
      SFV was similar to the off-line laser diffraction (LD) data. Analysis of the DOE 
      results showed that mainly the HPMC concentration and slightly the inlet air 
      temperature during drying had a positive effect on the average end granule size. 
      The in-line SFV particle size data, obtained every 10s during processing, further 
      allowed to explain and better understand the (in)significance of the studied DOE 
      variables, which was not possible based on the LD data as this technique only 
      supplied end granule size information. The variation in tapped density and 
      Hausner ratio among the end granules of the different DOE batches could be 
      explained by their difference in average end granule size. Univariate, 
      multivariate PLS and multiway N-PLS models were built to relate these end granule 
      properties to the in-line-measured particle size distribution. The multivariate 
      PLS tapped density model and the multiway N-PLS Hausner ratio model showed the 
      highest R(2) values in combination with the lowest RMSEE values (R(2) of 82% with 
      an RMSEE of 0.0279 for tapped density and an R(2) of 52% with an RMSEE of 0.0268 
      for Hausner ratio, respectively).
CI  - 2010 Elsevier B.V. All rights reserved.
FAU - Burggraeve, A
AU  - Burggraeve A
AD  - Department of Pharmaceutical Analysis, Ghent University, Ghent, Belgium.
FAU - Van Den Kerkhof, T
AU  - Van Den Kerkhof T
FAU - Hellings, M
AU  - Hellings M
FAU - Remon, J P
AU  - Remon JP
FAU - Vervaet, C
AU  - Vervaet C
FAU - De Beer, T
AU  - De Beer T
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20100608
PL  - Netherlands
TA  - Eur J Pharm Biopharm
JT  - European journal of pharmaceutics and biopharmaceutics : official journal of 
      Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
JID - 9109778
RN  - 0 (Excipients)
RN  - 0 (Polysorbates)
RN  - 0 (Powders)
RN  - 3NXW29V3WO (Hypromellose Derivatives)
RN  - 9004-67-5 (Methylcellulose)
RN  - 9005-25-8 (Starch)
RN  - IY9XDZ35W2 (Glucose)
SB  - IM
MH  - Chemistry, Pharmaceutical
MH  - Equipment Design
MH  - Excipients/*chemistry
MH  - Feasibility Studies
MH  - Glucose/chemistry
MH  - Hypromellose Derivatives
MH  - Materials Testing
MH  - Methylcellulose/analogs & derivatives/chemistry
MH  - Models, Statistical
MH  - Particle Size
MH  - Polysorbates/chemistry
MH  - Powders
MH  - Rheology/*instrumentation
MH  - Starch/chemistry
MH  - Technology, Pharmaceutical/*instrumentation
MH  - Temperature
EDAT- 2010/06/18 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/06/18 06:00
PHST- 2010/03/04 00:00 [received]
PHST- 2010/05/23 00:00 [revised]
PHST- 2010/06/02 00:00 [accepted]
PHST- 2010/06/18 06:00 [entrez]
PHST- 2010/06/18 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - S0939-6411(10)00149-9 [pii]
AID - 10.1016/j.ejpb.2010.06.001 [doi]
PST - ppublish
SO  - Eur J Pharm Biopharm. 2010 Sep;76(1):138-46. doi: 10.1016/j.ejpb.2010.06.001. 
      Epub 2010 Jun 8.