PMID- 23590129
OWN - NLM
STAT- MEDLINE
DCOM- 20141102
LR  - 20140225
IS  - 1520-5762 (Electronic)
IS  - 0363-9045 (Linking)
VI  - 40
IP  - 4
DP  - 2014 Apr
TI  - Understanding the thermodynamic micro-environment inside a pan coater using a 
      data logging device.
PG  - 542-8
LID - 10.3109/03639045.2013.772192 [doi]
AB  - OBJECTIVE: The objective of the current study was to establish the use of 
      PyroButton data-logging device to monitor and quantify the thermodynamic 
      environment (temperature and humidity) of a pan coating process. MATERIAL AND 
      METHODS: PyroButtons were placed (fixed) at various locations in a pan coater, 
      including exhaust plenum, spray-gun bar, baffles and were also allowed to freely 
      move with the tablet-bed. A full factorial design of experiments (DOE) study on 
      three process parameters, exhaust temperature, pan speed and spray rate was 
      conducted on a 24 inch pan coater, using a coating system and a core tablet 
      combination expected to have a narrow process operating space. RESULTS: It was 
      shown that the PyroButtons can provide a detailed and useful signature of the 
      coating process. PyroButton data showed that the tablet-bed temperature was 
      always lower than exhaust temperature and that the difference was a function of 
      the operating conditions such as spray rate. Similarly, the tablet-bed humidity 
      was found to always be higher than exhaust humidity. Some of the DOE batches 
      showed coating defects (logo-bridging). It was shown that the relative humidity 
      (RH), as measured by the freely-moving PyroButtons in the tablet-bed, correlated 
      well with the logo-bridging events. A critical RH value (30%) was established, 
      above which logo-bridging was observed for the selected formulation. CONCLUSIONS: 
      This study showed that PyroButtons can provide very meaningful 
      micro-environmental data that can be correlated to coating defects, and can aid 
      in establishing a process design space for a given coating and tablet 
      formulation.
FAU - Pandey, Preetanshu
AU  - Pandey P
AD  - Drug Product Science and Technology, Bristol-Myers Squibb , New Brunswick, NJ , 
      USA.
FAU - Ji, Jiangning
AU  - Ji J
FAU - Subramanian, Ganeshkumar
AU  - Subramanian G
FAU - Gour, Shruti
AU  - Gour S
FAU - Bindra, Dilbir S
AU  - Bindra DS
LA  - eng
PT  - Journal Article
DEP - 20130416
PL  - England
TA  - Drug Dev Ind Pharm
JT  - Drug development and industrial pharmacy
JID - 7802620
RN  - 0 (Excipients)
RN  - 0 (Tablets)
SB  - IM
MH  - Chemistry, Pharmaceutical/instrumentation/*methods
MH  - Equipment Design
MH  - Excipients/*chemistry
MH  - Humidity
MH  - Tablets
MH  - Temperature
MH  - *Thermodynamics
EDAT- 2013/04/18 06:00
MHDA- 2014/11/05 06:00
CRDT- 2013/04/18 06:00
PHST- 2013/04/18 06:00 [entrez]
PHST- 2013/04/18 06:00 [pubmed]
PHST- 2014/11/05 06:00 [medline]
AID - 10.3109/03639045.2013.772192 [doi]
PST - ppublish
SO  - Drug Dev Ind Pharm. 2014 Apr;40(4):542-8. doi: 10.3109/03639045.2013.772192. Epub 
      2013 Apr 16.