PMID- 30383810
OWN - NLM
STAT- MEDLINE
DCOM- 20190411
LR  - 20240403
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 13
IP  - 11
DP  - 2018
TI  - Quality by Design (QbD) based process optimisation to develop functionalised 
      particles with modified release properties using novel dry particle coating 
      technique.
PG  - e0206651
LID - 10.1371/journal.pone.0206651 [doi]
LID - e0206651
AB  - Quality by Design (QbD), a current trend employed to develop and optimise various 
      critical pharmaceutical processes, is a systematic approach based on the ethos 
      that quality should be designed into the product itself, not just end tested 
      after manufacture. The present work details a step-wise application of QbD 
      principles to optimise process parameters for production of particles with 
      modified functionalities, using dry particle coating technology. Initial risk 
      assessment identified speed, air pressure, processing time and batch size 
      (independent factors) as having high-to-medium impact on the dry coating process. 
      A design of experiments (DOE) using MODDE software employed a D-optimal design to 
      determine the effect of variations in these factors on identified responses 
      (content uniformity, dissolution rate, particle size and intensity of Fourier 
      transform infrared (FTIR) C = O spectrum). Results showed that batch size had the 
      most significant effect on dissolution rate, particle size and FTIR; with an 
      increase in batch size enhancing dissolution rate, decreasing particle size 
      (depicting absence of coated particles) and increasing the FTIR intensity. While 
      content uniformity was affected by various interaction terms, with speed and 
      batch size having the highest negative effect. Optimal design space for producing 
      functionalised particles with optimal properties required maximum air pressure 
      (40psi), low batch size (6g), speed between 850 to 1500 rpm and processing times 
      between 15 to 60 minutes. The validity and predictive ability of the revised 
      model demonstrated reliability for all experiments. Overall, QbD was demonstrated 
      to provide an expedient and cost effective tool for developing and optimising 
      processes in the pharmaceutical industry.
FAU - Dahmash, Eman Z
AU  - Dahmash EZ
AD  - Aston School of Pharmacy, Aston University, Birmingham, United Kingdom.
FAU - Al-Khattawi, Ali
AU  - Al-Khattawi A
AUID- ORCID: 0000-0002-2498-2817
AD  - Aston School of Pharmacy, Aston University, Birmingham, United Kingdom.
FAU - Iyire, Affiong
AU  - Iyire A
AD  - Aston School of Pharmacy, Aston University, Birmingham, United Kingdom.
FAU - Al-Yami, Hamad
AU  - Al-Yami H
AD  - Aston School of Pharmacy, Aston University, Birmingham, United Kingdom.
FAU - Dennison, Thomas J
AU  - Dennison TJ
AD  - Aston School of Pharmacy, Aston University, Birmingham, United Kingdom.
FAU - Mohammed, Afzal R
AU  - Mohammed AR
AD  - Aston School of Pharmacy, Aston University, Birmingham, United Kingdom.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20181101
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Delayed-Action Preparations)
RN  - 9004-34-6 (Cellulose)
RN  - OP1R32D61U (microcrystalline cellulose)
RN  - WK2XYI10QM (Ibuprofen)
SB  - IM
MH  - Air Pressure
MH  - Anti-Inflammatory Agents, Non-Steroidal/chemistry/pharmacokinetics
MH  - Cellulose/chemistry
MH  - Delayed-Action Preparations/*chemical synthesis/chemistry/pharmacokinetics
MH  - *Drug Design
MH  - Ibuprofen/chemistry/pharmacokinetics
MH  - Models, Theoretical
MH  - Particle Size
MH  - Risk Assessment
MH  - Software
MH  - Spectroscopy, Fourier Transform Infrared
PMC - PMC6211725
COIS- The authors have declared that no competing interests exist.
EDAT- 2018/11/02 06:00
MHDA- 2019/04/12 06:00
PMCR- 2018/11/01
CRDT- 2018/11/02 06:00
PHST- 2017/07/26 00:00 [received]
PHST- 2018/10/17 00:00 [accepted]
PHST- 2018/11/02 06:00 [entrez]
PHST- 2018/11/02 06:00 [pubmed]
PHST- 2019/04/12 06:00 [medline]
PHST- 2018/11/01 00:00 [pmc-release]
AID - PONE-D-17-27914 [pii]
AID - 10.1371/journal.pone.0206651 [doi]
PST - epublish
SO  - PLoS One. 2018 Nov 1;13(11):e0206651. doi: 10.1371/journal.pone.0206651. 
      eCollection 2018.