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Establishing a Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for Continuous Hot-Melt Extrusion of Oral Solid Dosage Forms
Subject area: Science,Engineering and Technology · Area of research: Hot-Melt Extrusion
DOI: https://doi.org/10.64388/IREV9I10-1716813
Abstract
The pharmaceutical manufacturing industry faces increasing regulatory and commercial pressure to transition from traditional batch-based production toward continuous manufacturing (CM) platforms that deliver superior process consistency, reduced cycle times, and proactive quality assurance. Oral Solid Dosage (OSD) forms, representing approximately 65% of all pharmaceutical products globally, stand at the forefront of this transformation. Twin-screw granulation (TSG) has emerged as the most widely adopted continuous wet granulation technology; however, its multi-parametric nature demands a rigorous, science-driven development framework. Quality by Design (QbD), formalized under ICH Q8(R2) and supported by ICH Q9, Q10, and Q12, provides precisely such a framework — enabling manufacturers to design quality into products and processes from the earliest stages of development rather than testing for it retrospectively at batch completion.
How to cite this paper
@article{1716813,
author = {Asharaf Yunusbhai Kalaniya},
title = {Establishing a Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for Continuous Hot-Melt Extrusion of Oral Solid Dosage Forms},
journal = {Iconic Research And Engineering Journals},
year = {2026},
volume = {9},
number = {10},
pages = {2961-2975},
issn = {2456-8880},
url = {https://www.irejournals.com/formatedpaper/1716813.pdf},
abstract = {The pharmaceutical manufacturing industry faces increasing regulatory and commercial pressure to transition from traditional batch-based production toward continuous manufacturing (CM) platforms that deliver superior process consistency, reduced cycle times, and proactive quality assurance. Oral Solid Dosage (OSD) forms, representing approximately 65% of all pharmaceutical products globally, stand at the forefront of this transformation. Twin-screw granulation (TSG) has emerged as the most widely adopted continuous wet granulation technology; however, its multi-parametric nature demands a rigorous, science-driven development framework. Quality by Design (QbD), formalized under ICH Q8(R2) and supported by ICH Q9, Q10, and Q12, provides precisely such a framework — enabling manufacturers to design quality into products and processes from the earliest stages of development rather than testing for it retrospectively at batch completion.},
month = {April},
doi = {https://doi.org/10.64388/IREV9I10-1716813}
}