Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations
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 disadvantag...
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-10-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/12/11/1019 |
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| author | Gauri Shadambikar Thomas Kipping Nicole Di-Gallo Alessandro-Giuseppe Elia Anja-Nadine Knüttel Daniel Treffer Michael. A Repka |
| author_facet | Gauri Shadambikar Thomas Kipping Nicole Di-Gallo Alessandro-Giuseppe Elia Anja-Nadine Knüttel Daniel Treffer Michael. A Repka |
| author_sort | Gauri Shadambikar |
| collection | DOAJ |
| description | 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<sup>®</sup> MXP, Soluplus<sup>®,</sup> Kollidon<sup>®</sup> VA 64, Eudragit<sup>®</sup> 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. |
| first_indexed | 2024-03-10T15:21:31Z |
| format | Article |
| id | doaj.art-383fcdb6a6444c969a6cd843df533458 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-10T15:21:31Z |
| publishDate | 2020-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-383fcdb6a6444c969a6cd843df5334582023-11-20T18:24:15ZengMDPI AGPharmaceutics1999-49232020-10-011211101910.3390/pharmaceutics12111019Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion FormulationsGauri Shadambikar0Thomas Kipping1Nicole Di-Gallo2Alessandro-Giuseppe Elia3Anja-Nadine Knüttel4Daniel Treffer5Michael. A Repka6Department of Pharmaceutics and Drug Delivery, University of Mississippi, Oxford, MS 38677, USAMerck KGaA, Frankfurter Str. 250, 64293 Darmstadt, GermanyMerck KGaA, Frankfurter Str. 250, 64293 Darmstadt, GermanyMerck KGaA, Frankfurter Str. 250, 64293 Darmstadt, GermanyMerck KGaA, Frankfurter Str. 250, 64293 Darmstadt, GermanyMeltPrep GmbH, Nikolaiplatz 4/3, 8020 Graz, AustriaDepartment of Pharmaceutics and Drug Delivery, University of Mississippi, Oxford, MS 38677, USAHot-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<sup>®</sup> MXP, Soluplus<sup>®,</sup> Kollidon<sup>®</sup> VA 64, Eudragit<sup>®</sup> 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.https://www.mdpi.com/1999-4923/12/11/1019polyvinyl alcoholscreening toolhot-melt extrusionamorphous solid dispersionformulation development |
| spellingShingle | Gauri Shadambikar Thomas Kipping Nicole Di-Gallo Alessandro-Giuseppe Elia Anja-Nadine Knüttel Daniel Treffer Michael. A Repka Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations Pharmaceutics polyvinyl alcohol screening tool hot-melt extrusion amorphous solid dispersion formulation development |
| title | Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations |
| title_full | Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations |
| title_fullStr | Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations |
| title_full_unstemmed | Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations |
| title_short | Vacuum Compression Molding as a Screening Tool to Investigate Carrier Suitability for Hot-Melt Extrusion Formulations |
| title_sort | vacuum compression molding as a screening tool to investigate carrier suitability for hot melt extrusion formulations |
| topic | polyvinyl alcohol screening tool hot-melt extrusion amorphous solid dispersion formulation development |
| url | https://www.mdpi.com/1999-4923/12/11/1019 |
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