Establishing a Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for Continuous Hot-Melt Extrusion of Oral Solid Dosage Forms

• Author(s): Asharaf Yunusbhai Kalaniya
• Paper ID: 1716813
• Page: 2961-2975
• Published Date: 27-04-2026
• Published In: Iconic Research And Engineering Journals
• Publisher: IRE Journals
• e-ISSN: 2456-8880
• Volume/Issue: Volume 9 Issue 10 April-2026

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.

Citations

IRE Journals:
Asharaf Yunusbhai Kalaniya "Establishing a Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for Continuous Hot-Melt Extrusion of Oral Solid Dosage Forms" Iconic Research And Engineering Journals Volume 9 Issue 10 2026 Page 2961-2975 https://doi.org/10.64388/IREV9I10-1716813

IEEE:
Asharaf Yunusbhai Kalaniya "Establishing a Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs) for Continuous Hot-Melt Extrusion of Oral Solid Dosage Forms" Iconic Research And Engineering Journals, 9(10) https://doi.org/10.64388/IREV9I10-1716813