Kolipaka, Siva Satyanarayana, Junqueira, Laura Andrade, Ross, Steven, Garg, Vivek ORCID: 0000-0002-8515-4759 , Mithu, Md Sadeque Hossain, Bhatt, Saumil and Douroumis, Dionysios ORCID: 0000-0002-3782-0091 (2024) An advanced twin‑screw granulation technology: the use of non‑volatile solvents with high solubilizing capacity. AAPS PharmSci Tech, 25:174. ISSN 1530-9932 (Online) (doi:https://doi.org/10.1208/s12249-024-02890-y)

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Abstract

Purpose
Twin-screw wet granulation (TSWG) is a manufacturing process that ofers several advantages for the processing of water-insoluble active pharmaceutical ingredients (APIs) and has been used for increasing the solubility and dissolution rates. Here we introduce a novel TSWG approach with reduced downstream processing steps by using non-volatile solvents as granulating binders. Methods Herein, TSWG was carried out using Transcutol a non-volatile protic solvent as a granulating binder and dissolution enhancer of ibuprofen (IBU) blends with cellulose polymer grades (Pharmacoat® 603, Afnisol™, and AQOAT®).
Results
The physicochemical characterisation of the produced granules showed excellent powder fow and the complete transformation of IBU into the amorphous state. Dissolution studies presented immediate release rates for all IBU formulations due to the high drug-polymer miscibility and the Transcutol solubilising capacity.
Conclusions
Overall, the study demonstrated an innovative approach for the development of extruded granules by processing water-insoluble APIs with non-volatile solvents for enhanced dissolution rates at high drug loadings.

Item Type:	Article
Uncontrolled Keywords:	immediate release, non-volatile solvents, solubility enhancement, twin-screw wet granulation
Subjects:	T Technology > TA Engineering (General). Civil engineering (General)
Faculty / School / Research Centre / Research Group:	Faculty of Engineering & Science Faculty of Engineering & Science > School of Engineering (ENG) Faculty of Engineering & Science > School of Science (SCI) Faculty of Engineering & Science > Wolfson Centre for Bulk Solids Handling Technology
Last Modified:	01 Aug 2024 10:28
URI:	http://gala.gre.ac.uk/id/eprint/47668

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