Examples of NIR based real time release in tablet manufacturing.
Real time release (RTR) of products is a new paradigm in the pharmaceutical industry. An RTR system assures that when the last manufacturing step is passed all the final release criteria are met. Various types of models can be used within the RTR framework. For each RTR system, the monitoring capability, control capability and RTR capability need to be tested. This paper presents some practical examples within the RTR framework using near-infrared and process data obtained from a tablet manufacturing process.
Skibsted
E T S
ET
Biosystems Data Analysis, Swammerdam Institute for Life Sciences, University of Amsterdam, Nieuwe Achtergracht 166, 1018 WV Amsterdam, The Netherlands.
Westerhuis
J A
JA
Smilde
A K
AK
Witte
D T
DT
D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004339:Drug Compounding; D015233:Models, Statistical; D013055:Spectrophotometry, Infrared / Q000379:methods*; D013607:Tablets / Q000737:chemistry*; D013678:Technology, Pharmaceutical
D013607:Tablets