Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach

Drug Delivery and Translational Research
Muhammad T IslamD Douroumis

Abstract

In this study, a quality-by-design (QbD) approach was used to optimize the development of paracetamol (PMOL) sustained-release formulations manufactured by hot-melt extrusion (HME). For the purpose of the study, in-line near-infrared (NIR) spectroscopy as a process analytical technology (PAT) was explored while a design of experiment (DoE) was implemented to assess the effect of the process critical parameters and to identify the critical quality attributes (CQA) of the extrusion processing. Blends of paracetamol, ethyl cellulose (EC) and Compritol® 888 ATO (C888) were processed using a twin screw extruder to investigate the effect of screw speed, feed rate and drug loading on the dissolution rates and particle size distribution. The principal component analysis (PCA) of the NIR collected signal revealed the optimum extrusion processing parameters. Furthermore, the integration of the DoE experiments demonstrated that drug loading has a significant effect on the only quality attribute, which was the PMOL dissolution rate. This QbD approach was employed as a paradigm for the development of pharmaceutical formulations via HME processing.

References

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Citations

Dec 23, 2015·AAPS PharmSciTech·Mohammed ManiruzzamanDennis Douroumis
Jul 5, 2015·International Journal of Pharmaceutics·Vilas N MalodePadma V Devarajan
Mar 4, 2015·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·N JedingerE Roblegg
Nov 12, 2017·Drug Delivery and Translational Research·Yongcheng LiChuanbin Wu
Apr 23, 2019·Expert Opinion on Drug Delivery·Venkata Raman KallakuntaMichael A Repka
Oct 23, 2019·Pharmaceutical Development and Technology·Mohammed Rohi SanoufiNizar Al-Zoubi
Nov 9, 2020·AAPS PharmSciTech·Deck Khong TanAli Nokhodchi
Dec 1, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Arun ButreddyMichael A Repka
Mar 16, 2021·Journal of Drug Delivery Science and Technology·Sagar NaralaMichael A Repka
May 1, 2021·Pharmaceutics·Uttom NandiDennis Douroumis
Jun 19, 2021·AAPS PharmSciTech·Marta F SimõesSérgio Simões
Jun 24, 2021·International Journal of Pharmaceutics: X·Josip MatićJohannes Khinast

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