Development of Porous Polyurethane Implants Manufactured via Hot-Melt Extrusion
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Methods
2.2.1. Rheological Properties and Thermal Characterization
2.2.2. Manufacturing of the Porous Extrudates
2.2.3. Apparent Density and Ovality Measurements
2.2.4. True and Skeletal Density
2.2.5. Pore Morphology
2.2.6. Mechanical Properties
2.2.7. Liquid Uptake
3. Results and Discussion
3.1. Rheological Properties, Thermal Characterization and Manufacturing
3.2. Apparent Density and Ovality Measurements
3.3. True and Skeletal Density
3.4. Pore Morphology
3.5. Mechanical Properties
3.6. Liquid Uptake
4. Conclusions
- For the TPUs investigated, only PF with decomposition temperatures that overlap with the HME temperature, i.e., NaHCO3, led to a reproducible porous network.
- For both TPU types and the employed experimental setup, the porosity increased with increasing PF concentrations and reached a maximum at 40%. However, the appropriate PF concentration to reach the porosity maximum depended on the TPU type (i.e., hydrophobic or hydrophilic), as the gases produced due to PF decomposition during HME played a major role in the pore nucleation kinetics, leading to faster pore formation for the hydrophilic TPU. The final pore size was not affected by the hydrophilicity of the TPUs, but rather by geometrical constraints. As a result, the average pore size decreased and the pore size distribution became narrower with increasing PF content. In addition, the porous network became more interconnected whereby the initially closed-cell pores gradually rearranged into open-cell pores with increasing PF concentration.
- The compression properties of the porous extrudates were strongly influenced by the porosity and the pore morphology. Due to the smaller pores, extrudates comprising 5 wt% of PF resulted in a comparable compression modulus and compressive stress as extrudates containing 1 wt%, despite their difference in porosity. Consequently, IDDS with a broad application portfolio in terms of porosity, but comparable and consistent mechanical properties were produced.
- Depending on the hydrophilicity of the TPU, a wide range of liquid uptake was obtained, which correlated directly with the extrudate porosity. For the hydrophobic TPU, a 20-fold increase in mass was found, since liquid uptake was determined by the number of open-cell pores. Due to the high liquid uptake of the pure hydrophilic TPU, only a 1.6-fold mass increase, which was dependent on the total porosity, was achieved for the porous hydrophilic extrudates.
- Based on the results of the extrudate characterization, both hydrophobic and hydrophilic drugs can be considered as candidates. The release of a hydrophobic API will be increased due to the larger surface area provided by the open-cell pores of HPB and by the higher total porosity of HPL. However, due to the rapid liquid uptake of the porous HPL extrudates, PF concentrations lower than 1 wt% should be investigated to reduce the uptake of large medium amounts and avoid the immediate release of the API. Due to its high solubility in aqueous media, a hydrophilic API might be mainly considered in combination with the porous HPB carrier for a delayed, extended-release formulation.
5. Patents
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Sample Designation | Polymer Type | NaHCO3 (wt%) |
---|---|---|
HPB | Hydrophobic TPU | - |
HPB/NaHCO3-1 | 1 | |
HPB/NaHCO3-3 | 3 | |
HPB/NaHCO3-5 | 5 | |
HPL | Hydrophilic TPU | - |
HPL/NaHCO3-1 | 1 | |
HPL/NaHCO3-3 | 3 | |
HPL/NaHCO3-5 | 5 |
Sample Designation | Da (µm) |
---|---|
HPB/NaHCO3-1 | 596 ± 240 |
HPB/NaHCO3-3 | 475 ± 247 |
HPB/NaHCO3-5 | 146 ± 108 |
HPL/NaHCO3-1 | 523 ± 281 |
HPL/NaHCO3-3 | 405 ± 290 |
HPL/NaHCO3-5 | 137 ± 100 |
Sample Designation | EC (MPa) | σ50 (MPa) |
---|---|---|
HPB | 5.34 ± 0.98 | 7.75 ± 0.37 |
HPB/NaHCO3-1 | 2.51 ± 0.68 | 5.67 ± 1.19 |
HPB/NaHCO3-3 | 1.71 ± 0.51 | 1.58 ± 0.08 |
HPB/NaHCO3-5 | 2.41 ± 0.65 | 3.76 ± 0.65 |
HPL | 7.40 ± 0.69 | 12.16 ± 1.37 |
HPL/NaHCO3-1 | 3.75 ± 1.25 | 4.48 ± 0.72 |
HPL/NaHCO3-3 | 1.97 ± 0.79 | 1.53 ± 0.42 |
HPL/NaHCO3-5 | 4.38 ± 1.52 | 6.26 ± 0.50 |
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Koutsamanis, I.; Spoerk, M.; Arbeiter, F.; Eder, S.; Roblegg, E. Development of Porous Polyurethane Implants Manufactured via Hot-Melt Extrusion. Polymers 2020, 12, 2950. https://doi.org/10.3390/polym12122950
Koutsamanis I, Spoerk M, Arbeiter F, Eder S, Roblegg E. Development of Porous Polyurethane Implants Manufactured via Hot-Melt Extrusion. Polymers. 2020; 12(12):2950. https://doi.org/10.3390/polym12122950
Chicago/Turabian StyleKoutsamanis, Ioannis, Martin Spoerk, Florian Arbeiter, Simone Eder, and Eva Roblegg. 2020. "Development of Porous Polyurethane Implants Manufactured via Hot-Melt Extrusion" Polymers 12, no. 12: 2950. https://doi.org/10.3390/polym12122950