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Hot-Melt Extrusion as an Advantageous Technology to Obtain Effervescent Drug Products
Open AccessArticle

Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations

1
Department of Pharmaceutics and Drug Delivery, University of Mississippi, Oxford, MS 38677, USA
2
Merck KGaA, Frankfurter Str. 250, 64293 Darmstadt, Germany
3
MeltPrep GmbH, Nikolaiplatz 4/3, 8020 Graz, Austria
*
Author to whom correspondence should be addressed.
Pharmaceutics 2020, 12(11), 1019; https://doi.org/10.3390/pharmaceutics12111019
Received: 23 September 2020 / Revised: 14 October 2020 / Accepted: 20 October 2020 / Published: 24 October 2020
(This article belongs to the Special Issue Hot-Melt Extrusion: Applications in Pharmaceutics)
Hot-melt extrusion (HME) is the most preferred and effective method for manufacturing amorphous solid dispersions at production scale, but it consumes large amounts of samples when used for formulation development. Herein, we show a novel approach to screen the polymers by overcoming the disadvantage of conventional HME screening by using a minimum quantity of active pharmaceutical ingredient (API). Vacuum Compression Molding (VCM) is a fusion-based method to form solid specimens starting from powders. This study aimed to investigate the processability of VCM for the creation of amorphous formulations and to compare its results with HME-processed formulations. Mixtures of indomethacin (IND) with drug carriers (Parteck® MXP, Soluplus®, Kollidon® VA 64, Eudragit® EPO) were processed using VCM and extrusion technology. Thermal characterization was performed using differential scanning calorimetry, and the solid-state was analyzed via X-ray powder diffraction. Dissolution studies in the simulated gastric fluid were performed to evaluate the drug release. Both technologies showed similar results proving the effectiveness of VCM as a screening tool for HME-based formulations. View Full-Text
Keywords: polyvinyl alcohol; screening tool; hot-melt extrusion; amorphous solid dispersion; formulation development polyvinyl alcohol; screening tool; hot-melt extrusion; amorphous solid dispersion; formulation development
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MDPI and ACS Style

Shadambikar, G.; Kipping, T.; Di-Gallo, N.; Elia, A.-G.; Knüttel, A.-N.; Treffer, D.; Repka, M.A. Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations. Pharmaceutics 2020, 12, 1019. https://doi.org/10.3390/pharmaceutics12111019

AMA Style

Shadambikar G, Kipping T, Di-Gallo N, Elia A-G, Knüttel A-N, Treffer D, Repka MA. Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations. Pharmaceutics. 2020; 12(11):1019. https://doi.org/10.3390/pharmaceutics12111019

Chicago/Turabian Style

Shadambikar, Gauri; Kipping, Thomas; Di-Gallo, Nicole; Elia, Alessandro-Giuseppe; Knüttel, Anja-Nadine; Treffer, Daniel; Repka, Michael. A 2020. "Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations" Pharmaceutics 12, no. 11: 1019. https://doi.org/10.3390/pharmaceutics12111019

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