PMID- 22570275
OWN - NLM
STAT- MEDLINE
DCOM- 20121022
LR  - 20161125
IS  - 1520-6017 (Electronic)
IS  - 0022-3549 (Linking)
VI  - 101
IP  - 8
DP  - 2012 Aug
TI  - Development of a fluid bed granulation design space using critical quality 
      attribute weighted tolerance intervals.
PG  - 2917-29
LID - 10.1002/jps.23185 [doi]
AB  - The fluid bed granulation and drying unit operation were used as a case study for 
      control systems implementation. This single processor was used to blend, 
      granulate, dry, and cool the materials. The current study demonstrated control of 
      each of the phases using a fully automated, hybrid control system that 
      incorporated first-principle modeling, empirical design of experiments (DOE), and 
      process analytical technology to assure the production of constant product 
      quality. The system allowed data to be collected efficiently for the development 
      of a rigorous design space that combined formulation factors, process factors, 
      and their interactions to define a tolerance surface where risk of future product 
      failure was significantly reduced. The DOE incorporated microcrystalline 
      cellulose and lactose monohydrate, excipients with substantially different 
      wetting properties, to elucidate the relationship between the critical process 
      parameters of the unit operation and the material properties of the formulation 
      components. The extended analysis of covariance model enabled these factors and 
      their interaction terms to be described in a single model. The results indicate 
      that the development of a tolerance interval-based weighted design space can 
      enhance product understanding and thereby help to assure future product quality.
CI  - Copyright (c) 2012 Wiley Periodicals, Inc.
FAU - Zacour, Brian M
AU  - Zacour BM
AD  - Duquesne Center for Pharmaceutical Technology, Duquesne University, Pittsburgh, 
      Pennsylvania 15282, USA.
FAU - Drennen, James K 3rd
AU  - Drennen JK 3rd
FAU - Anderson, Carl A
AU  - Anderson CA
LA  - eng
PT  - Journal Article
DEP - 20120508
PL  - United States
TA  - J Pharm Sci
JT  - Journal of pharmaceutical sciences
JID - 2985195R
RN  - 0 (Excipients)
RN  - 9004-34-6 (Cellulose)
RN  - J2B2A4N98G (Lactose)
RN  - OP1R32D61U (microcrystalline cellulose)
SB  - IM
MH  - Cellulose/*chemistry
MH  - Drug Compounding/*methods
MH  - Excipients/*chemistry
MH  - Lactose/*chemistry
MH  - Models, Chemical
MH  - Models, Statistical
MH  - Particle Size
EDAT- 2012/05/10 06:00
MHDA- 2012/10/23 06:00
CRDT- 2012/05/10 06:00
PHST- 2012/02/28 00:00 [received]
PHST- 2012/03/27 00:00 [revised]
PHST- 2012/04/19 00:00 [accepted]
PHST- 2012/05/10 06:00 [entrez]
PHST- 2012/05/10 06:00 [pubmed]
PHST- 2012/10/23 06:00 [medline]
AID - S0022-3549(15)31478-7 [pii]
AID - 10.1002/jps.23185 [doi]
PST - ppublish
SO  - J Pharm Sci. 2012 Aug;101(8):2917-29. doi: 10.1002/jps.23185. Epub 2012 May 8.