PMID- 24180259
OWN - NLM
STAT- MEDLINE
DCOM- 20150824
LR  - 20141217
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 41
IP  - 1
DP  - 2015 Jan
TI  - Media milling process optimization for manufacture of drug nanoparticles using 
      design of experiments (DOE).
PG  - 124-30
LID - 10.3109/03639045.2013.850709 [doi]
AB  - Design of experiments (DOE), a component of Quality by Design (QbD), is 
      systematic and simultaneous evaluation of process variables to develop a product 
      with predetermined quality attributes. This article presents a case study to 
      understand the effects of process variables in a bead milling process used for 
      manufacture of drug nanoparticles. Experiments were designed and results were 
      computed according to a 3-factor, 3-level face-centered central composite design 
      (CCD). The factors investigated were motor speed, pump speed and bead volume. 
      Responses analyzed for evaluating these effects and interactions were milling 
      time, particle size and process yield. Process validation batches were executed 
      using the optimum process conditions obtained from software Design-Expert(R) to 
      evaluate both the repeatability and reproducibility of bead milling technique. 
      Milling time was optimized to <5 h to obtain the desired particle size 
      (d90 < 400 nm). The desirability function used to optimize the response variables 
      and observed responses were in agreement with experimental values. These results 
      demonstrated the reliability of selected model for manufacture of drug 
      nanoparticles with predictable quality attributes. The optimization of bead 
      milling process variables by applying DOE resulted in considerable decrease in 
      milling time to achieve the desired particle size. The study indicates the 
      applicability of DOE approach to optimize critical process parameters in the 
      manufacture of drug nanoparticles.
FAU - Nekkanti, Vijaykumar
AU  - Nekkanti V
AD  - Department of Pharmacy, Western University of Health Sciences, Pomona , CA , USA 
      and.
FAU - Marwah, Ashwani
AU  - Marwah A
FAU - Pillai, Raviraj
AU  - Pillai R
LA  - eng
PT  - Journal Article
DEP - 20131104
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - U202363UOS (Fenofibrate)
SB  - IM
MH  - Chemistry, Pharmaceutical/methods/*standards
MH  - Fenofibrate/chemical synthesis/standards
MH  - Nanoparticles/*chemistry/*standards
MH  - Particle Size
MH  - Quality Improvement/*standards
OTO - NOTNLM
OT  - Bead milling
OT  - QbD
OT  - central composite design
OT  - design of experiments
OT  - process optimization
EDAT- 2013/11/05 06:00
MHDA- 2015/08/25 06:00
CRDT- 2013/11/05 06:00
PHST- 2013/11/05 06:00 [entrez]
PHST- 2013/11/05 06:00 [pubmed]
PHST- 2015/08/25 06:00 [medline]
AID - 10.3109/03639045.2013.850709 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2015 Jan;41(1):124-30. doi: 10.3109/03639045.2013.850709. 
      Epub 2013 Nov 4.