PMID- 29305693
OWN - NLM
STAT- MEDLINE
DCOM- 20180720
LR  - 20181202
IS  - 1530-9932 (Electronic)
IS  - 1530-9932 (Linking)
VI  - 19
IP  - 3
DP  - 2018 Apr
TI  - A Scale-up Approach for Film Coating Process Based on Surface Roughness as the 
      Critical Quality Attribute.
PG  - 1243-1253
LID - 10.1208/s12249-017-0940-9 [doi]
AB  - Scale-up approaches for film coating process have been established for each type 
      of film coating equipment from thermodynamic and mechanical analyses for several 
      decades. The objective of the present study was to establish a versatile scale-up 
      approach for film coating process applicable to commercial production that is 
      based on critical quality attribute (CQA) using the Quality by Design (QbD) 
      approach and is independent of the equipment used. Experiments on a pilot scale 
      using the Design of Experiment (DoE) approach were performed to find a suitable 
      CQA from surface roughness, contact angle, color difference, and coating film 
      properties by terahertz spectroscopy. Surface roughness was determined to be a 
      suitable CQA from a quantitative appearance evaluation. When surface roughness 
      was fixed as the CQA, the water content of the film-coated tablets was determined 
      to be the critical material attribute (CMA), a parameter that does not depend on 
      scale or equipment. Finally, to verify the scale-up approach determined from the 
      pilot scale, experiments on a commercial scale were performed. The good 
      correlation between the surface roughness (CQA) and the water content (CMA) 
      identified at the pilot scale was also retained at the commercial scale, 
      indicating that our proposed method should be useful as a scale-up approach for 
      film coating process.
FAU - Yoshino, Hiroyuki
AU  - Yoshino H
AD  - Pharmaceutical Research & Technology Laboratories, Astellas Pharma Inc., 180 
      Ozumi, Yaizu, Shizuoka, 425-0072, Japan.
AD  - Department of Pharmaceutical Engineering, Graduate School of Pharmaceutical 
      Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, 
      Japan.
FAU - Hara, Yuko
AU  - Hara Y
AD  - Pharmaceutical Research & Technology Laboratories, Astellas Pharma Inc., 180 
      Ozumi, Yaizu, Shizuoka, 425-0072, Japan.
FAU - Dohi, Masafumi
AU  - Dohi M
AD  - Pharmaceutical Research & Technology Laboratories, Astellas Pharma Inc., 180 
      Ozumi, Yaizu, Shizuoka, 425-0072, Japan.
FAU - Yamashita, Kazunari
AU  - Yamashita K
AD  - Pharmaceutical Research & Technology Laboratories, Astellas Pharma Inc., 180 
      Ozumi, Yaizu, Shizuoka, 425-0072, Japan.
FAU - Hakomori, Tadashi
AU  - Hakomori T
AD  - Pharmaceutical Research & Technology Laboratories, Astellas Pharma Inc., 180 
      Ozumi, Yaizu, Shizuoka, 425-0072, Japan.
FAU - Kimura, Shin-Ichiro
AU  - Kimura SI
AD  - Department of Pharmaceutical Engineering, Graduate School of Pharmaceutical 
      Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, 
      Japan.
FAU - Iwao, Yasunori
AU  - Iwao Y
AD  - Department of Pharmaceutical Engineering, Graduate School of Pharmaceutical 
      Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, 
      Japan.
FAU - Itai, Shigeru
AU  - Itai S
AD  - Department of Pharmaceutical Engineering, Graduate School of Pharmaceutical 
      Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka, 422-8526, 
      Japan. s-itai@u-shizuoka-ken.ac.jp.
LA  - eng
PT  - Journal Article
DEP - 20180105
PL  - United States
TA  - AAPS PharmSciTech
JT  - AAPS PharmSciTech
JID - 100960111
RN  - 0 (Tablets)
RN  - 059QF0KO0R (Water)
SB  - IM
MH  - Drug Compounding/methods
MH  - Pilot Projects
MH  - Surface Properties
MH  - Tablets/*chemistry
MH  - Water/analysis
OTO - NOTNLM
OT  - appearance
OT  - critical material attribute
OT  - critical quality attribute
OT  - film coating
OT  - scale-up
EDAT- 2018/01/07 06:00
MHDA- 2018/07/22 06:00
CRDT- 2018/01/07 06:00
PHST- 2017/08/08 00:00 [received]
PHST- 2017/12/14 00:00 [accepted]
PHST- 2018/01/07 06:00 [pubmed]
PHST- 2018/07/22 06:00 [medline]
PHST- 2018/01/07 06:00 [entrez]
AID - 10.1208/s12249-017-0940-9 [pii]
AID - 10.1208/s12249-017-0940-9 [doi]
PST - ppublish
SO  - AAPS PharmSciTech. 2018 Apr;19(3):1243-1253. doi: 10.1208/s12249-017-0940-9. Epub 
      2018 Jan 5.