Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation
Pellet production is a multi-step manufacturing process comprising granulation, extrusion and spheronisation. The first step represents a critical control point, since the quality of the granule mass highly influences subsequent process steps and, consequently, the quality of final pellets. The most...
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| Format: | Article |
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MDPI AG
2022-10-01
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| Series: | Pharmaceutics |
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| Online Access: | https://www.mdpi.com/1999-4923/14/11/2303 |
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| author | Selina Ramm Ruwen Fulek Veronika Anna Eberle Christian Kiera Ulrich Odefey Miriam Pein-Hackelbusch |
| author_facet | Selina Ramm Ruwen Fulek Veronika Anna Eberle Christian Kiera Ulrich Odefey Miriam Pein-Hackelbusch |
| author_sort | Selina Ramm |
| collection | DOAJ |
| description | Pellet production is a multi-step manufacturing process comprising granulation, extrusion and spheronisation. The first step represents a critical control point, since the quality of the granule mass highly influences subsequent process steps and, consequently, the quality of final pellets. The most important parameter of wet granulation is the liquid requirement, which can often only be quantitatively evaluated after further process steps. To identify an alternative for optimal liquid requirements, experiments were conducted with a formulation based on lactose and microcrystalline cellulose. Granules were analyzed with a Powder Vertical Shear Rig. We identified the compression density (<i>ρ</i><sub>press</sub>) as the said alternative, linking information from the powder material and the moisture content (<i>R</i><sup>2</sup> = 0.995). We used <i>ρ</i><sub>press</sub> to successfully predict liquid requirements for unknown formulation compositions. By means of this prediction, pellets with high quality, regarding shape and size distribution, were produced by carrying out a multi-step manufacturing process. Furthermore, the applicability of <i>ρ</i><sub>press</sub> as an alternative quality parameter to other placebo formulations and to formulations containing active pharmaceutical ingredients (APIs) was demonstrated. |
| first_indexed | 2024-03-09T18:44:53Z |
| format | Article |
| id | doaj.art-406c1281569b418ba03c145480607b65 |
| institution | Directory Open Access Journal |
| issn | 1999-4923 |
| language | English |
| last_indexed | 2024-03-09T18:44:53Z |
| publishDate | 2022-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceutics |
| spelling | doaj.art-406c1281569b418ba03c145480607b652023-11-24T06:19:59ZengMDPI AGPharmaceutics1999-49232022-10-011411230310.3390/pharmaceutics14112303Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for SpheronisationSelina Ramm0Ruwen Fulek1Veronika Anna Eberle2Christian Kiera3Ulrich Odefey4Miriam Pein-Hackelbusch5Department of Life Science Technologies, OWL University of Applied Sciences and Arts, Campusallee 12, 32657 Lemgo, GermanyDepartment of Life Science Technologies, OWL University of Applied Sciences and Arts, Campusallee 12, 32657 Lemgo, GermanyPHARBIL Pharma GmbH, Reichenbergerstr. 43, 33605 Bielefeld, GermanyPHARBIL Pharma GmbH, Reichenbergerstr. 43, 33605 Bielefeld, GermanyDepartment of Life Science Technologies, OWL University of Applied Sciences and Arts, Campusallee 12, 32657 Lemgo, GermanyDepartment of Life Science Technologies, OWL University of Applied Sciences and Arts, Campusallee 12, 32657 Lemgo, GermanyPellet production is a multi-step manufacturing process comprising granulation, extrusion and spheronisation. The first step represents a critical control point, since the quality of the granule mass highly influences subsequent process steps and, consequently, the quality of final pellets. The most important parameter of wet granulation is the liquid requirement, which can often only be quantitatively evaluated after further process steps. To identify an alternative for optimal liquid requirements, experiments were conducted with a formulation based on lactose and microcrystalline cellulose. Granules were analyzed with a Powder Vertical Shear Rig. We identified the compression density (<i>ρ</i><sub>press</sub>) as the said alternative, linking information from the powder material and the moisture content (<i>R</i><sup>2</sup> = 0.995). We used <i>ρ</i><sub>press</sub> to successfully predict liquid requirements for unknown formulation compositions. By means of this prediction, pellets with high quality, regarding shape and size distribution, were produced by carrying out a multi-step manufacturing process. Furthermore, the applicability of <i>ρ</i><sub>press</sub> as an alternative quality parameter to other placebo formulations and to formulations containing active pharmaceutical ingredients (APIs) was demonstrated.https://www.mdpi.com/1999-4923/14/11/2303wet granulationliquid requirementgranulation endpointcompression density |
| spellingShingle | Selina Ramm Ruwen Fulek Veronika Anna Eberle Christian Kiera Ulrich Odefey Miriam Pein-Hackelbusch Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation Pharmaceutics wet granulation liquid requirement granulation endpoint compression density |
| title | Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation |
| title_full | Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation |
| title_fullStr | Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation |
| title_full_unstemmed | Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation |
| title_short | Compression Density as an Alternative to Identify an Optimal Moisture Content for High Shear Wet Granulation as an Initial Step for Spheronisation |
| title_sort | compression density as an alternative to identify an optimal moisture content for high shear wet granulation as an initial step for spheronisation |
| topic | wet granulation liquid requirement granulation endpoint compression density |
| url | https://www.mdpi.com/1999-4923/14/11/2303 |
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