Highlights
- This technique reduces the uncertainty of sample based release procedures.
- The dosage of each individual tablet can be predicted and calculated inline.
- 100% in-line screening applies on both R&D and manufacturing scale.
- High throughput inline inspection can help in understanding product variability.
- 100% in-line inspection could fit in both “Quality by Design” or “Final Quality” concepts.
Abstract
In the scope of 100% in-line quality control and real-time release of pharmaceutical tablets, the authors present a flexible inspection module for in-line tablet analysis with integrated multipoint near-infrared (NIR) spectroscopy and 3D microwave resonance technology (3D MRT). Via an industrial case study on Diclofenac Sodium tablets, the abilities of this versatile process analytical technology (PAT) tool are presented. It is demonstrated that the combination of Diclofenac concentration prediction via NIR spectroscopy and mass prediction via 3D MRT allow to estimate the dosage of each individual tablet. Single sample repetition tests were performed on 5 tablets, measured 10 times on three different days. A high accuracy and precision of prediction was shown, with an average standard deviation below 0.5 mg. The inspection run demonstrated the added value of such inspection and sorting strategies based on the calculated dosage of individual tablets.
Authors & Co-Authors
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Indatech Chauvin Arnoux, 4 Rue Georges Besse, 34830 Clapiers, France
Davinia Brouckaert
Fabien Chauchard - Pharma Technology, Rue Graham Bell 8, 1402 Thines (Nivelles), Belgium
Freddy Vandenbroucke
Martial Dollinger - Novartis Pharma AG, CH-4002 Basel, Switzerland
Yves Roggo
Laurent Pellegatti
Markus Krumme
Read the full article
https://www.sciencedirect.com/science/article/abs/pii/S0731708521006026#!