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Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach.
Drug Deliv Transl Res 2014; 4(4):377-87DD

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.

Authors+Show Affiliations

Faculty of Engineering and Science, University of Greenwich, Medway Campus, Chatham Maritime, Chatham, Kent, ME4 4TB, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

25787069

Citation

Islam, Muhammad T., et al. "Development of Sustained-release Formulations Processed By Hot-melt Extrusion By Using a Quality-by-design Approach." Drug Delivery and Translational Research, vol. 4, no. 4, 2014, pp. 377-87.
Islam MT, Maniruzzaman M, Halsey SA, et al. Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach. Drug Deliv Transl Res. 2014;4(4):377-87.
Islam, M. T., Maniruzzaman, M., Halsey, S. A., Chowdhry, B. Z., & Douroumis, D. (2014). Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach. Drug Delivery and Translational Research, 4(4), pp. 377-87. doi:10.1007/s13346-014-0197-8.
Islam MT, et al. Development of Sustained-release Formulations Processed By Hot-melt Extrusion By Using a Quality-by-design Approach. Drug Deliv Transl Res. 2014;4(4):377-87. PubMed PMID: 25787069.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of sustained-release formulations processed by hot-melt extrusion by using a quality-by-design approach. AU - Islam,Muhammad T, AU - Maniruzzaman,Mohammed, AU - Halsey,Sheelagh A, AU - Chowdhry,Babur Z, AU - Douroumis,Dennis, PY - 2015/3/20/entrez PY - 2015/3/20/pubmed PY - 2015/3/20/medline SP - 377 EP - 87 JF - Drug delivery and translational research JO - Drug Deliv Transl Res VL - 4 IS - 4 N2 - 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. SN - 2190-3948 UR - https://www.unboundmedicine.com/medline/citation/25787069/Development_of_sustained_release_formulations_processed_by_hot_melt_extrusion_by_using_a_quality_by_design_approach_ L2 - https://dx.doi.org/10.1007/s13346-014-0197-8 DB - PRIME DP - Unbound Medicine ER -