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Pharmaceutics
Volume 17
Issue 5
10.3390/pharmaceutics17050662
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Article

Feasibility of Hot Melt Extrusion in Converting Water-Based Nanosuspensions into Solid Dosage Forms

by
Erasmo Ragucci
1,
Marco Uboldi
1,
Adam Sobczuk
2,
Giorgio Facchetti
3,
Alice Melocchi
1,*,
Mauro Serratoni
2 and
Lucia Zema
1
1
PhormulaMi Research Group, Sezione di Tecnologia e Legislazione Farmaceutiche “Maria Edvige Sangalli”, Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Via Giuseppe Colombo 71, 20133 Milano, Italy
2
Novartis Pharma AG, 4056 Basel, Switzerland
3
Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano, Via Venezian 21, 20133 Milano, Italy
*
Author to whom correspondence should be addressed.
Pharmaceutics 2025, 17(5), 662; https://doi.org/10.3390/pharmaceutics17050662
Submission received: 7 April 2025 / Revised: 13 May 2025 / Accepted: 14 May 2025 / Published: 17 May 2025
(This article belongs to the Special Issue Advances in Hot Melt Extrusion Technology)
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Abstract

Aim: In addition to numerous benefits provided by nanosuspensions (NSs) (e.g., enhanced saturation solubility, increased area for interaction with fluids), they suffer from major stability, handling and compliance issues. To overcome these challenges, we evaluated the feasibility of hot melt extrusion (HME) in transforming a cinnarizine-based NS, selected as a case study, into granules for oral intake. Methods: Thermoplastic polymers, in principle compatible with the thermal behavior of the selected drug and characterized by different interaction mechanisms with aqueous fluids, were used as carriers to absorb the NS and were processed by HME. Results: The extruded granules pointed out good physio-technological characteristics, a drug content > 85% with coefficient of variation (CV) < 5% and tunable in vitro performance coherent with the polymeric carriers they were composed of. Particle size as well as the solid state of cinnarizine was checked using several analytical techniques in combination (e.g., DSC, SEM, FT-IR, Raman). Depending on the composition of the granules, and specifically for formulations processed below 85 °C, the drug was found to remain crystalline and in the desired nanoscale. Conclusions: HME turned out to be a versatile process to transform, in a single-step, NSs into multi-particulate solid products for oral administration showing a variety of release profiles.
Keywords: hot melt extrusion; nanosuspension; granules; immediate release; modified release hot melt extrusion; nanosuspension; granules; immediate release; modified release
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MDPI and ACS Style

Ragucci, E.; Uboldi, M.; Sobczuk, A.; Facchetti, G.; Melocchi, A.; Serratoni, M.; Zema, L. Feasibility of Hot Melt Extrusion in Converting Water-Based Nanosuspensions into Solid Dosage Forms. Pharmaceutics 2025, 17, 662. https://doi.org/10.3390/pharmaceutics17050662

AMA Style

Ragucci E, Uboldi M, Sobczuk A, Facchetti G, Melocchi A, Serratoni M, Zema L. Feasibility of Hot Melt Extrusion in Converting Water-Based Nanosuspensions into Solid Dosage Forms. Pharmaceutics. 2025; 17(5):662. https://doi.org/10.3390/pharmaceutics17050662

Chicago/Turabian Style

Ragucci, Erasmo, Marco Uboldi, Adam Sobczuk, Giorgio Facchetti, Alice Melocchi, Mauro Serratoni, and Lucia Zema. 2025. "Feasibility of Hot Melt Extrusion in Converting Water-Based Nanosuspensions into Solid Dosage Forms" Pharmaceutics 17, no. 5: 662. https://doi.org/10.3390/pharmaceutics17050662

APA Style

Ragucci, E., Uboldi, M., Sobczuk, A., Facchetti, G., Melocchi, A., Serratoni, M., & Zema, L. (2025). Feasibility of Hot Melt Extrusion in Converting Water-Based Nanosuspensions into Solid Dosage Forms. Pharmaceutics, 17(5), 662. https://doi.org/10.3390/pharmaceutics17050662

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