PMID- 23638984
OWN - NLM
STAT- MEDLINE
DCOM- 20150105
LR  - 20140519
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 40
IP  - 6
DP  - 2014 Jun
TI  - Correlating bilayer tablet delamination tendencies to micro-environmental 
      thermodynamic conditions during pan coating.
PG  - 829-37
LID - 10.3109/03639045.2013.788014 [doi]
AB  - OBJECTIVE: The objective of this study was to determine the impact that the 
      micro-environment, as measured by PyroButton data loggers, experienced by tablets 
      during the pan coating unit operation had on the layer adhesion of bilayer 
      tablets in open storage conditions. MATERIALS AND METHODS: A full factorial 
      design of experiments (DOE) with three center points was conducted to study the 
      impact of final tablet hardness, film coating spray rate and film coating exhaust 
      temperature on the delamination tendencies of bilayer tablets. PyroButton data 
      loggers were placed (fixed) at various locations in a pan coater and were also 
      allowed to freely move with the tablet bed to measure the micro-environmental 
      temperature and humidity conditions of the tablet bed. RESULTS: The variance in 
      the measured micro-environment via PyroButton data loggers accounted for 75% of 
      the variance in the delamination tendencies of bilayer tablets on storage 
      (R(2 )= 0.75). A survival analysis suggested that tablet hardness and coating 
      spray rate significantly impacted the delamination tendencies of the bilayer 
      tablets under open storage conditions. The coating exhaust temperature did not 
      show good correlation with the tablets' propensity to crack indicating that it 
      was not representative of the coating micro-environment. Models created using 
      data obtained from the PyroButton data loggers outperformed models created using 
      primary DOE factors in the prediction of bilayer tablet strength, especially upon 
      equipment or scale transfers. CONCLUSION: The coating micro-environment 
      experienced by tablets during the pan coating unit operation significantly 
      impacts the strength of the bilayer interface of tablets on storage.
FAU - Zacour, Brian M
AU  - Zacour BM
AD  - Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick, NJ , 
      USA.
FAU - Pandey, Preetanshu
AU  - Pandey P
FAU - Subramanian, Ganeshkumar
AU  - Subramanian G
FAU - Gao, Julia Z
AU  - Gao JZ
FAU - Nikfar, Faranak
AU  - Nikfar F
LA  - eng
PT  - Journal Article
DEP - 20130503
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Drug Combinations)
RN  - 0 (Excipients)
RN  - 0 (Tablets)
SB  - IM
MH  - *Drug Combinations
MH  - Drug Compounding/*methods/standards
MH  - Drug Stability
MH  - Drug Storage
MH  - Excipients/chemistry
MH  - Hardness
MH  - Models, Chemical
MH  - Tablets/*chemistry/*standards
MH  - *Thermodynamics
OTO - NOTNLM
OT  - Bilayer
OT  - PyroButton data loggers
OT  - delamination
OT  - micro-environmental humidity, micro-environmental temperature
OT  - pan coating
OT  - tablet-bed humidity
OT  - tablet-bed temperature
EDAT- 2013/05/04 06:00
MHDA- 2015/01/06 06:00
CRDT- 2013/05/04 06:00
PHST- 2013/05/04 06:00 [entrez]
PHST- 2013/05/04 06:00 [pubmed]
PHST- 2015/01/06 06:00 [medline]
AID - 10.3109/03639045.2013.788014 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2014 Jun;40(6):829-37. doi: 10.3109/03639045.2013.788014. 
      Epub 2013 May 3.