Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.2. Production of Naproxen Nanosuspensions
2.3. Fluidized Bed Granulation
2.4. Characterization of Materials and Granules
2.4.1. Particle Size Measurement
2.4.2. Redispersibility of Granules
2.4.3. Gas Pycnometry
2.4.4. Apparent Intrinsic Dissolution Rate of Carrier Materials
2.4.5. Scanning Electron Microscopy
2.4.6. Confocal Raman Microscopy
3. Results and Discussion
3.1. Production of Naproxen Nanosuspensions
3.2. Fluidized Bed Granulation of Naproxen Nanosuspensions
3.2.1. Influence of Carrier Material
3.2.2. Influence of Polymer Concentration in the Nanosuspension
3.2.3. Influence of Polymer Type in the Nanosuspension
4. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Carrier Material | X10 | X50 | X90 | Sm | ρsolid |
---|---|---|---|---|---|
[µm] | [µm] | [µm] | [m2·g−1] | [g·cm−3] | |
lactose | 14.6 | 57.7 | 139.0 | 0.266 | 1.5366 |
mannitol | 10.4 | 71.5 | 238.0 | 0.263 | 1.4839 |
sucrose (air jet sieved) | 16.2 | 44.5 | 111.0 | 0.248 | 1.5852 |
Ratio Polymer/API [-] | cm,carrier1 [-] | cm,polymer1 [-] | cm,API1 [-] |
---|---|---|---|
0.250 | 0.889 | 0.022 | 0.089 |
0.375 | 0.878 | 0.033 | 0.089 |
0.500 | 0.867 | 0.044 | 0.089 |
0.625 | 0.856 | 0.055 | 0.089 |
0.750 | 0.844 | 0.067 | 0.089 |
0.875 2 | 0.833 | 0.078 | 0.089 |
Carrier Material | εcompact [-] |
---|---|
sucrose | 0.118 ± 0.004 |
mannitol | 0.113 ± 0.002 |
lactose | 0.120 ± 0.008 |
Stabilizers | After Milling | 3 Days of Storage | 7 Days of Storage | |||
---|---|---|---|---|---|---|
z-avg. | PdI | z-avg. | PdI | z-avg. | PdI | |
[nm] | [-] | [nm] | [-] | [nm] | [-] | |
2.50 wt% PVP/VA + 0.25 wt% SDS | 132.7 | 0.13 | 147.5 | 0.13 | 154.1 | 0.11 |
2.50 wt% HPMC + 0.25 wt% SDS | 141.6 | 0.12 | 153.2 | 0.14 | 155.9 | 0.14 |
Carrier Material | Apparent IDR [mg·cm−2·min−1] | R2 [-] |
---|---|---|
sucrose | 1.623 ± 0.062 | 0.994 |
mannitol | 0.640 ± 0.029 | 0.992 |
lactose | 0.290 ± 0.031 | 0.956 |
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Wewers, M.; Czyz, S.; Finke, J.H.; John, E.; Van Eerdenbrugh, B.; Juhnke, M.; Bunjes, H.; Kwade, A. Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process. Pharmaceutics 2020, 12, 363. https://doi.org/10.3390/pharmaceutics12040363
Wewers M, Czyz S, Finke JH, John E, Van Eerdenbrugh B, Juhnke M, Bunjes H, Kwade A. Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process. Pharmaceutics. 2020; 12(4):363. https://doi.org/10.3390/pharmaceutics12040363
Chicago/Turabian StyleWewers, Martin, Stefan Czyz, Jan Henrik Finke, Edgar John, Bernard Van Eerdenbrugh, Michael Juhnke, Heike Bunjes, and Arno Kwade. 2020. "Influence of Formulation Parameters on Redispersibility of Naproxen Nanoparticles from Granules Produced in a Fluidized Bed Process" Pharmaceutics 12, no. 4: 363. https://doi.org/10.3390/pharmaceutics12040363