Abstract
Monitoring powder potency and homogeneity is important in achieving real-time release testing in a continuous tablet manufacturing operation. If quality related issues are encountered, monitoring powder potency inside a feed frame offers a last opportunity to intervene in the process before tablet compression. Feed frame monitoring methods based on near infrared (NIR) spectroscopy have been increasingly reported in recent years. New process analytical tools with the potential of being deployed alone or in combination with NIR spectroscopy for feed frame monitoring are now available commercially. The present study evaluated the potential of near infrared chemical imaging (NIR CI) for in-line monitoring of a prototype pharmaceutical composition containing ascorbic acid (AA), microcrystalline cellulose and dicalcium phosphate. NIR spectroscopy was the reference method. In-line calibration models based on partial least square regression were developed and validated with a range of AA concentrations. The ability of NIR spectroscopy and NIR CI to predict concentrations in test runs was ascertained both independently and in combination. NIR CI, with a single bandpass filter, predicted AA concentrations—present at commercially relevant concentrations—with acceptable accuracy. Comparative results showed that NIR CI has the potential for in-line monitoring of blend concentrations inside feed frames. In addition to the advantage of increased sample size, it also has the potential to detect segregation inside feed frames.
Highlights
Pharmaceutical regulatory authorities require compliance of every manufactured product batch with preapproved specifications before its release to market
The main aim of this study was to evaluate the possibility of near infrared (NIR) CI as a Process analytical technology (PAT) tool for in-line feed frame monitoring while using NIR spectroscopy as reference method
In the present set-up, sample volume tested by near infrared chemical imaging (NIR CI) was five times higher than NIR spectroscopy
Summary
Pharmaceutical regulatory authorities require compliance of every manufactured product batch with preapproved specifications before its release to market. Real-time release of pharmaceuticals is becoming possible by taking advantage of recent technological advances as well as recommendations from regulatory agencies for continuous process monitoring.[1] Product and process information collected during manufacturing can ensure that it complies with intended quality stand-. Concentration Monitoring with Near Infrared Chemical Imaging in a Tableting Press ards. Such information can be obtained by measuring the critical quality attributes (CQAs) of raw materials, in-process materials and critical process parameters (CPPs) during different manufacturing stages. Process analytical technology (PAT) tools enable CPP and CQA measurements in-line, on-line and at-line during the manufacture of different dosage forms, such as tablets, capsules and liquids.[2]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
