Reduction of submicron particle agglomeration via melt foaming in solid crystalline suspension

References

• Amidon, G. L.; Lennernäs, H.; Shah, V. P.; Crison, J. R. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability. Pharm. Res. 1995, 12, 413–420. DOI: 10.1023/A:1016212804288.
   PubMed Web of Science ®Google Scholar
• van Duong, T.; van den Mooter, G. The Role of the Carrier in the Formulation of Pharmaceutical Solid Dispersions. Part I: Crystalline and Semi-Crystalline Carriers. Expert Opin. Drug Deliv. 2016, 13, 1583–1594. DOI: 10.1080/17425247.2016.1198768.
   PubMed Web of Science ®Google Scholar
• Gigliobianco, M. R.; Casadidio, C.; Censi, R.; Di Martino, P. Nanocrystals of Poorly Soluble Drugs: Drug Bioavailability and Physicochemical Stability. Pharmaceutics 2018, 10, 134. DOI: 10.3390/pharmaceutics10030134.
   PubMed Web of Science ®Google Scholar
• Shegokar, R.; Müller, R. H. Nanocrystals: Industrially Feasible Multifunctional Formulation Technology for Poorly Soluble Actives. Int. J. Pharm. 2010, 399, 129–139. DOI: 10.1016/j.ijpharm.2010.07.044.
   PubMed Web of Science ®Google Scholar
• Dobrowolski, A.; Strob, R.; Dräger-Gillessen, J. F.; Pieloth, D.; Schaldach, G.; Wiggers, H.; Thommes, M. Preparation of Submicron Drug Particles via Spray Drying from Organic Solvents. Int. J. Pharm. 2019, 567, 118501. DOI: 10.1016/j.ijpharm.2019.118501.
   PubMedGoogle Scholar
• Keck, C. M.; Müller, R. H. Drug Nanocrystals of Poorly Soluble Drugs Produced by High Pressure Homogenisation. Eur. J. Pharm. Biopharm. 2006, 62, 3–16. DOI: 10.1016/j.ejpb.2005.05.009.
   PubMed Web of Science ®Google Scholar
• Bitterlich, A.; Laabs, C.; Busmann, E.; Grandeury, A.; Juhnke, M.; Bunjes, H.; Kwade, A. Challenges in Nanogrinding of Active Pharmaceutical Ingredients. Chem. Eng. Technol. 2014, 37, 840–846. DOI: 10.1002/ceat.201300697.
   Web of Science ®Google Scholar
• Stenger, F.; Mende, S.; Schwedes, J.; Peukert, W. Nanomilling in Stirred Media Mills. Chem. Eng. Sci. 2005, 60, 4557–4565. DOI: 10.1016/j.ces.2005.02.057.
   Web of Science ®Google Scholar
• Da Igreja, P.; Erve, A.; Thommes, M. Melt Milling as Manufacturing Method for Solid Crystalline Suspensions. Eur. J. Pharm. Biopharm. 2021, 158, 245–253. DOI: 10.1016/j.ejpb.2020.11.020.
   PubMed Web of Science ®Google Scholar
• Thommes, M.; Ely, D. R.; Carvajal, M. T.; Pinal, R. Improvement of the Dissolution Rate of Poorly Soluble Drugs by Solid Crystal Suspensions. Mol. Pharm. 2011, 8, 727–735. DOI: 10.1021/mp1003493.
   PubMed Web of Science ®Google Scholar
• Sokolov, S. V.; Kätelhön, E.; Compton, R. G. A Thermodynamic View of Agglomeration. J. Phys. Chem. C 2015, 119, 25093–25099. DOI: 10.1021/acs.jpcc.5b07893.
   Web of Science ®Google Scholar
• Rabinow, B. E. Nanosuspensions in Drug Delivery. Nat. Rev. Drug Discov. 2004, 3, 785–796. DOI: 10.1038/nrd1494.
   PubMed Web of Science ®Google Scholar
• Tadros, T. F., Ed. Pharmaceutical, Cosmetic and Personal Care Formulations; De Gruyter: Berlin, Boston, 2018.
   Google Scholar
• Bhakay, A.; Merwade, M.; Bilgili, E.; Dave, R. N. Novel Aspects of Wet Milling for the Production of Microsuspensions and Nanosuspensions of Poorly Water-Soluble Drugs. Drug Dev. Ind. Pharm. 2011, 37, 963–976. DOI: 10.3109/03639045.2010.551775.
   PubMed Web of Science ®Google Scholar
• Nöske, M.; Breitung-Faes, S.; Kwade, A. Electrostatic Stabilization and Characterization of Fine Ground Silicon Particles in Ethanol. Silicon 2019, 11, 3001–3010. DOI: 10.1007/s12633-019-0089-0.
   Web of Science ®Google Scholar
• van Eerdenbrugh, B.; Vermant, J.; Martens, J. A.; Froyen, L.; van Humbeeck, J.; Augustijns, P.; van den Mooter, G. A Screening Study of Surface Stabilization during the Production of Drug Nanocrystals. J. Pharm. Sci. 2009, 98, 2091–2103. DOI: 10.1002/jps.21563.
   PubMed Web of Science ®Google Scholar
• 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. DOI: 10.3390/pharmaceutics12040363.
   PubMed Web of Science ®Google Scholar
• Anhalt, K.; Geissler, S.; Harms, M.; Weigandt, M.; Fricker, G. Development of a New Method to Assess Nanocrystal Dissolution Based on Light Scattering. Pharm. Res. 2012, 29, 2887–2901. DOI: 10.1007/s11095-012-0795-4.
   PubMed Web of Science ®Google Scholar
• Townley, E. R. Griseofulvin. Analytical Profiles of Drug Substances 1979, 8, 219–249. DOI: 10.1016/S0099-5428(08)60119-7.
   Google Scholar
• Peukert, W.; Schwarzer, H.-C.; Stenger, F. Control of Aggregation in Production and Handling of Nanoparticles. Chem. Eng. Process 2005, 44, 245–252. DOI: 10.1016/j.cep.2004.02.018.
   Web of Science ®Google Scholar
• Knieke, C.; Peukert, W.; Sommer, M. Identifying the Apparent and True Grinding Limit. Powder Technol. 2009, 195, 25–30. DOI: 10.1016/j.powtec.2009.05.007.
   Web of Science ®Google Scholar
• Sadowski, Z. Hydrophobic Agglomeration of Fine Particles. In Mineral Processing and the Environment, Gallios, G. P., Matis, K. A., Eds.; Springer Netherlands: Dordrecht, 1998; pp 3–24
   Google Scholar
• Li, M.; Alvarez, P.; Orbe, P.; Bilgili, E. Multi-Faceted Characterization of Wet-Milled Griseofulvin Nanosuspensions for Elucidation of Aggregation State and Stabilization Mechanisms. AAPS PharmSciTech 2018, 19, 1789–1801. DOI: 10.1208/s12249-018-0993-4.
   PubMed Web of Science ®Google Scholar
• Bilgili, E.; Afolabi, A. A Combined Microhydrodynamics-Polymer Adsorption Analysis for Elucidation of the Roles of Stabilizers in Wet Stirred Media Milling. Int. J. Pharm. 2012, 439, 193–206. DOI: 10.1016/j.ijpharm.2012.09.040.
   PubMed Web of Science ®Google Scholar
• Bhakay, A.; Davé, R.; Bilgili, E. Recovery of BCS Class II Drugs during Aqueous Redispersion of Core–Shell Type Nanocomposite Particles Produced via Fluidized Bed Coating. Powder Technol. 2013, 236, 221–234. DOI: 10.1016/j.powtec.2011.12.066.
   Web of Science ®Google Scholar
• Afolabi, A.; Akinlabi, O.; Bilgili, E. Impact of Process Parameters on the Breakage Kinetics of Poorly Water-Soluble Drugs during Wet Stirred Media Milling: A Microhydrodynamic View. Eur. J. Pharm. Sci. 2014, 51, 75–86. DOI: 10.1016/j.ejps.2013.09.002.
   PubMed Web of Science ®Google Scholar
• Sievens-Figueroa, L.; Bhakay, A.; Jerez-Rozo, J. I.; Pandya, N.; Romañach, R. J.; Michniak-Kohn, B.; Iqbal, Z.; Bilgili, E.; Davé, R. N. Preparation and Characterization of Hydroxypropyl Methyl Cellulose Films Containing Stable BCS Class II Drug Nanoparticles for Pharmaceutical Applications. Int. J. Pharm. 2012, 423, 496–508. DOI: 10.1016/j.ijpharm.2011.12.001.
   PubMed Web of Science ®Google Scholar
• Monteiro, A.; Afolabi, A.; Bilgili, E. Continuous Production of Drug Nanoparticle Suspensions via Wet Stirred Media Milling: A Fresh Look at the Rehbinder Effect. Drug Dev. Ind. Pharm. 2013, 39, 266–283. DOI: 10.3109/03639045.2012.676048.
   PubMed Web of Science ®Google Scholar
• Bhakay, A.; Azad, M.; Bilgili, E.; Dave, R. Redispersible Fast Dissolving Nanocomposite Microparticles of Poorly Water-Soluble Drugs. Int. J. Pharm. 2014, 461, 367–379. DOI: 10.1016/j.ijpharm.2013.11.059.
   PubMed Web of Science ®Google Scholar
• Reitz, E. Extrudierte Feste Dispersionen Zur Verbesserung Der Lösungsgeschwindigkeit Und Bioverfügbarkeit. PhD Thesis, Heinrich-Heine Universität, Düsseldorf, 2014.
   Google Scholar
• Wang, Y.; Zheng, Y.; Zhang, L.; Wang, Q.; Zhang, D. Stability of Nanosuspensions in Drug Delivery. J. Control Release 2013, 172, 1126–1141. DOI: 10.1016/j.jconrel.2013.08.006.
   PubMed Web of Science ®Google Scholar
• Knieke, C. Fracture at the Nanoscale and the Limit of Grinding. PhD Thesis, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, 2012.
   Google Scholar
• Binks, B. P. Macroporous Silica From Solid-Stabilized Emulsion Templates. Adv. Mater. 2002, 14, 1824–1827. DOI: 10.1002/adma.200290010.
   Web of Science ®Google Scholar
• Pugh, R. J. Particle-Stabilized Foams. In Bubble and Foam Chemistry; Pugh, R. J., Ed.; Cambridge University Press: Cambridge, 2016; pp 269–306
   Google Scholar
• Madelung, P.; Ostergaard, J.; Bertelsen, P.; Jørgensen, E. V.; Jacobsen, J.; Müllertz, A. Impact of Sodium Dodecyl Sulphate on the Dissolution of Poorly Soluble Drug into Biorelevant Medium from Drug-Surfactant Discs. Int. J. Pharm. 2014, 467, 1–8. DOI: 10.1016/j.ijpharm.2014.02.043.
   PubMedGoogle Scholar