Literature DB >> 35739377

Implementation of Dynamic and Static Moisture Control in Fluidized Bed Granulation.

Liang Zhong1, Lele Gao1, Lian Li1, Lei Nie1, Hui Zhang1, Zhongyu Sun1, Ruiqi Huang1, Zhaobang Zhou1, Wenping Yin2, Hui Wang2, Hengchang Zang3,4,5.   

Abstract

The application of process analysis and control is essential to enhance process understanding and ensure output material quality. The present study focuses on the stability of the feedback control system for a fluidized bed granulation process. Two strategies of dynamic moisture control (DMC) and static moisture control (SMC) were established based on the in-line moisture value obtained from the near-infrared sensor and control algorithm. The performance of these strategies on quality consistency control was examined using process moisture similarity analysis and principal component analysis. The stable moisture control performance and low batch-to-batch variability indicated that the DMC method was significantly better than other granulation methods. In addition, the investigation of robustness further showed that the implemented DMC method was able to produce predetermined target moisture values by varying process parameters. This study provides an advanced and simple control method for fluidized bed granulation quality assurance.
© 2022. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.

Entities:  

Keywords:  Dynamic moisture control; Fluidized bed granulation; Near-infrared spectroscopy; Quality consistency; Static moisture control

Year:  2022        PMID: 35739377     DOI: 10.1208/s12249-022-02334-5

Source DB:  PubMed          Journal:  AAPS PharmSciTech        ISSN: 1530-9932            Impact factor:   3.246


  23 in total

1.  Development and characterization of aqueous amylose-rich maize starch dispersion for film formation.

Authors:  K Krogars; J Heinämäki; M Karjalainen; J Rantanen; P Luukkonen; J Yliruusi
Journal:  Eur J Pharm Biopharm       Date:  2003-09       Impact factor: 5.571

2.  Focused beam reflectance method as an innovative (PAT) tool to monitor in-line granulation process in fluidized bed.

Authors:  Firas Alshihabi; Thierry Vandamme; Gabriele Betz
Journal:  Pharm Dev Technol       Date:  2011-10-29       Impact factor: 3.133

3.  Evaluation of in-line spatial filter velocimetry as PAT monitoring tool for particle growth during fluid bed granulation.

Authors:  A Burggraeve; T Van Den Kerkhof; M Hellings; J P Remon; C Vervaet; T De Beer
Journal:  Eur J Pharm Biopharm       Date:  2010-06-08       Impact factor: 5.571

4.  The effect of inert atmospheric packaging on oxidative degradation in formulated granules.

Authors:  Rajiv Mahajan; Allen Templeton; Amy Harman; Robert A Reed; Rey T Chern
Journal:  Pharm Res       Date:  2005-01       Impact factor: 4.200

5.  Novel description of a design space for fluidised bed granulation.

Authors:  Tanja Lipsanen; Osmo Antikainen; Heikki Räikkönen; Sari Airaksinen; Jouko Yliruusi
Journal:  Int J Pharm       Date:  2007-05-29       Impact factor: 5.875

6.  Phase transformations of erythromycin A dihydrate during pelletisation and drying.

Authors:  Meike Römer; Jyrki Heinämäki; Inna Miroshnyk; Niklas Sandler; Jukka Rantanen; Jouko Yliruusi
Journal:  Eur J Pharm Biopharm       Date:  2006-12-21       Impact factor: 5.571

7.  Combining microwave resonance technology to multivariate data analysis as a novel PAT tool to improve process understanding in fluid bed granulation.

Authors:  Vera Lourenço; Thorsten Herdling; Gabriele Reich; José C Menezes; Dirk Lochmann
Journal:  Eur J Pharm Biopharm       Date:  2011-02-17       Impact factor: 5.571

8.  Inline real-time near-infrared granule moisture measurements of a continuous granulation-drying-milling process.

Authors:  Lipika Chablani; Michael K Taylor; Amit Mehrotra; Patrick Rameas; William C Stagner
Journal:  AAPS PharmSciTech       Date:  2011-08-13       Impact factor: 3.246

Review 9.  Trends-process analytical technology in solid oral dosage manufacturing.

Authors:  Liang Zhong; Lele Gao; Lian Li; Hengchang Zang
Journal:  Eur J Pharm Biopharm       Date:  2020-06-18       Impact factor: 5.571

10.  Phase transformation of erythromycin A dihydrate during fluid bed drying.

Authors:  Meike Römer; Jyrki Heinämäki; Inna Miroshnyk; Niina Kivikero; Niklas Sandler; Jukka Rantanen; Jouko Yliruusi
Journal:  J Pharm Sci       Date:  2008-09       Impact factor: 3.534

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