Optimization of nano spray drying parameters for production of α-amylase nanopowder for biotheraputic applications using factorial design

References

• Mateo, C.; Palomo, J.; Fernandez-Lorente, G.; Guisan, G.; Fernandez-Lafuente, R. Improvement of Enzyme Activity, Stability and Selectivity via Immobilization Techniques. Enzyme Microb. Technol. 2007, 40, 1451–1463. DOI:10.1016/j.enzmictec.2007.01.018.
   Web of Science ®Google Scholar
• Maltesen, M.; van de Weert, M. Drying Methods for Protein Pharmaceuticals. Drug Discov. Today Technol. 2008, 5, e81–e88.
   PubMedGoogle Scholar
• Abdel-Mageed, H. M.; Fahmy, A. S.; Shaker, D. S.; Mohamed, S. A. Development of Novel Delivery System for Nanoencapsulation of Catalase: Formulation, Characterization, and In Vivo Evaluation Using Oxidative Skin Injury Model. Artif. Cells Nanomed. Biotech. 2018, 16, 1–10. DOI:10.1080/21691401.2018.1425213.
   Google Scholar
• Namaldi, A.; Çalik, P.; Uludag, Y. Effects of Spray Drying Temperature and Additives on the Stability of Serine Alkaline Protease Powders. Drying Technol. 2006, 24, 1495–1500. DOI:10.1080/07373930600961108.
   Web of Science ®Google Scholar
• Terebiznik, M. R.; Buera, M.; Pilosof, A. Thermal Stability of Dehydrated Alpha-Amylase in Trehalose Matrices in Relation to Its Phase Transitions. Food Sci. Technol. 1997, 30, 513–518. DOI:10.1006/fstl.1996.0210.
   Web of Science ®Google Scholar
• Estevinho, B.; Damas, A.; Martins, P.; Rocha, F. Microencapsulation of β-Galactosidase with Different Biopolymers by a Spray-Drying Process. Food Res. Int. 2014, 64, 34–140. DOI:10.1016/j.foodres.2014.05.057
   PubMed Web of Science ®Google Scholar
• Ameri, M.; Maa, Y. Spray Drying of Biopharmaceuticals: Stability and Process Considerations. Drying Technol. 2006, 24, 763–768. DOI:10.1080/03602550600685275.
   Web of Science ®Google Scholar
• Broadhead, J.; Rouan, S.; Rhodes, C. The Spray Drying of Pharmaceuticals. Drug Develop. Ind. Pharm. 1992, 18, 1169–1206. DOI:10.3109/03639049209046327.
   Web of Science ®Google Scholar
• Lee, S.; Heng, D.; Kiong, W.; Chan, H.; Tan, H. Nano Spray Drying: A Novel Method for Preparing Protein Nanoparticles for Protein Therapy. Int. J. Pharm. 2011, 403, 192–200. DOI:10.1016/j.ijpharm.2010.10.012.
   PubMed Web of Science ®Google Scholar
• Arpagaus, C. A Novel Laboratory-Scale Spray Dryer to Produce Nanoparticles. Drying Technol. 2012, 30, 1113–1121. DOI:10.1080/07373937.2012.686949.
   Web of Science ®Google Scholar
• Kanojia, G.; Have, R.; Soema, P. C.; Frijlink, H.; Amorij, J.-P.; Kersten, G. Developments in the Formulation and Delivery of Spray Dried Vaccines. Hum. Vaccines Immunother. 2017, 13, 2364–2378. DOI:10.1080/21645515.2017.1356952.
   PubMed Web of Science ®Google Scholar
• Li, X.; Anton, N.; Arpagaus, C.; Belleteix, F.; Vandamme, T. F. Nanoparticles by Spray Drying Using Innovative New Technology: The Büchi Nano Spray Dryer B-90. J. Control Release 2010, 147, 304–310.
   PubMed Web of Science ®Google Scholar
• Bürki, K.; Jeona, I.; Arpagaus, C.; Betza, G. New Insights into Respirable Protein Powder Preparation Using a Nano Spray Dryer. Int. J. Pharm. 2011, 408, 248–256. DOI:10.1016/j.ijpharm.2011.02.012.
   Google Scholar
• Schmid, K.; Arpagaus, C.; Friess, W. Evaluation of the Nano Spray Dryer B-90 for Pharmaceutical Applications. Pharm. Dev. Technol. 2011, 16, 287–294. DOI:10.3109/10837450.2010.485320.
   PubMed Web of Science ®Google Scholar
• Lipiäinen, T.; Räikkönen, H.; Kolu, A.; Peltoniemi, M.; Juppo, A. Comparison of Melibiose and Trehalose as Stabilising Excipients for Spray-dried β-Galactosidase Formulations. Int. J. Pharm. 2018, 543, 21–28. 30; DOI:10.1016/j.ijpharm.2018.03.035.
   PubMedGoogle Scholar
• Haggag, Y.; Faheem, A. Evaluation of Nano Spray Drying as a Method for Drying and Formulation of Therapeutic Peptides and Proteins. Front. Pharmacol. 2015, 6, 140. doi: 10.3389/fphar.2015.00140
   PubMed Web of Science ®Google Scholar
• Simair, A.; Qureshi, A.; Khushk, I.; Ali, C.; Lashari, S.; Bhutto, M.; Mangrio, G.; Lu, C. Production and Partial Characterization of α-Amylase Enzyme from Bacillus sp. BCC 01-50 and Potential Applications. Biomed. Res. Int. 2017, 2017, 1–9173040. DOI:10.1155/2017/9173040.
   Web of Science ®Google Scholar
• Dumoulin, Y.; Cartilier, L.; Mateescu, M. Cross-Linked Amylase Tablets Containing Alpha-Amylase: an Enzymatically-Controlled Drug Release System. J. Control. Release. 1999, 60, 161–167. DOI:10.1016/S0168-3659(99)00065-6.
   PubMed Web of Science ®Google Scholar
• Tavano, O. L.; Fernandez-Lafuente, R.; Goulart, A. J.; Monti, R. Optimization of the Immobilization of Sweet Potato Amylase Using Glutaraldehyde-Agarose Support. Characterization of the Immobilized Enzyme. Process Biochem. 2013, 48, 1054–1058. DOI:10.1016/j.procbio.2013.05.009.
   Web of Science ®Google Scholar
• Homaei, A.; Saberi, D. Immobilization of α-Amylase on Gold Nano Rods: An Ideal System for Starch Processing. Process Biochem. 2015, 50, 1394–1399. DOI:10.1016/j.procbio.2015.06.002.
   Web of Science ®Google Scholar
• Prinn, K.; Costantino, H.; Tracy, M. Statistical Modeling of Protein Spray Drying at the Lab Scale. AAPS Pharm. Sci. Tech. 2002, 3, 1–8.
   Google Scholar
• Bernfeld, P. A. α and β. Methods Enzymol. 1955, 1, 149–151.
   Web of Science ®Google Scholar
• Harsha, S. Pharmaceutical Suspension Containing Both Immediate/Sustained-Release Amoxicillin-Loaded Gelatin Nanoparticles: Preparation and In Vitro Characterization. Drug Des. Dev. Ther. 2013, 7, 1027–1033.
   PubMed Web of Science ®Google Scholar
• Samborska, K.; Witrowa-Rajchert, D.; Gonçalves, A. Spray-Drying of α-Amylase -The Effect of Process Variables on the Enzyme Inactivation. Drying Tech. 2005, 23, 941–953. DOI:10.1081/DRT-200054243.
   Web of Science ®Google Scholar
• Ståhl, K.; Claesson, M.; Lilliehorn, P.; Lindén, H.; Bäckström, K. The Effect of Process Variables on the Degradation and Physical Properties of Spray Dried Insulin Intended for Inhalation. Int. J. Pharm. 2002, 233, 227–237. DOI:10.1016/S0378-5173(01)00945-0.
   PubMed Web of Science ®Google Scholar
• Langford, A.; Bhatnagar, B.; Walters, R.; Tchessalov, S.; Ohtake, S. Drying Technologies for Biopharmaceutical Applications: Recent Developments and Future Direction. Drying Technol. 2018, 36, 677–684. DOI:10.1080/07373937.2017.1355318.
   Web of Science ®Google Scholar
• Schüle, S.; Schulz-Fademrecht, T.; Garidel, P.; Bechtold-Peters, K.; Frieß, W. Stabilization of IgG1 in Spray-dried Powders for Inhalation. Eur. J. Pharm. Biopharm. 2008, 69, 793–807. DOI:10.1016/j.ejpb.2008.02.010.
   PubMed Web of Science ®Google Scholar
• Kerwin, B. A. Polysorbates 20 and 80 Used in the Formulation of Protein Biotherapeutics: Structure and Degradation Pathways. J Pharm. Sci. 2008, 97, 2924–2935. DOI:10.1002/jps.21190.
   PubMed Web of Science ®Google Scholar
• Wang, W.; Wang, Y.; Wang, D. Dual Effects of Tween 80 on Protein Stability. Int. J. Pharm. 2008, 347, 31–38.
   PubMed Web of Science ®Google Scholar
• Adler, M.; Unger, M.; Lee, G. Surface Composition of Spray-dried Particles of Bovine Serum Albumin/trehalose/Surfactant. Pharm. Res. 2000, 17, 863–870. DOI:10.1023/A:1007568511399.
   PubMed Web of Science ®Google Scholar
• Kaerger, J.; Price, R. Processing of Spherical Crystalline Particles via a Novel Solution Atomization and Crystallization by Sonication (SAXS) Technique. Pharm. Res. 2004, 21, 372–381. DOI:10.1023/B:PHAM.0000016252.97296.f1.
   PubMed Web of Science ®Google Scholar
• Maa, Y. F.; Costantino, H. R.; Nguyen, P.-A.; Hsu, C. C. The Effect of Operating and Formulation Variables on the Morphology of Spray-dried Protein Particles. Pharm. Dev. Technol. 1997, 2, 213–223. DOI:10.3109/10837459709031441.
   PubMed Web of Science ®Google Scholar
• Salama, R. O.; Traini, D.; Chan, H.-K.; Sung, A.; Ammit, A. J.; Young, P. M. Preparation and Evaluation of Controlled Release Microparticles for Respiratory Protein Therapy. J. Pharm. Sci. 2009, 98, 2709–2717. DOI:10.1002/jps.21653.
   PubMed Web of Science ®Google Scholar
• Schmid, K.; Arpagaus, C.; Friess, W. Evaluation of a Vibrating Mesh Spray Dryer for Preparation of Submicron Particles. RDD Europe. 2009, 2, 323–326.
   Google Scholar
• Feng, A. L.; Boraey, M. A.; Gwin, M. A.; Finlay, P. R.; Kuehl, P. J.; Vehring, R. Mechanistic Models Facilitate Efficient Development of Leucine Containing Microparticles for Pulmonary Drug Delivery. Int. J. Pharm. 2011, 409, 156–163. DOI:10.1016/j.ijpharm.2011.02.049.
   PubMed Web of Science ®Google Scholar
• de Souza, P.; Magalhães, P. Application of Microbial α-Amylase in Industry – A Review. Braz. J. Microbiol. 2010, 41, 850–861.
   PubMed Web of Science ®Google Scholar
• von Halling Laier, C.; Sonne Alstrøm, T.; Travers, Bargholz, M.; Bjerg Sjøltov, P.; Rades, T.; Boisen, A.; Hagner Nielsen, L. Evaluation of the Effects of Spray Drying Parameters for Producing Cubosome Powder Precursors. Eur. J. Pharm. Biopharm. 2019, 135, 44–48. DOI:10.1016/j.ejpb.2018.12.008.
   PubMed Web of Science ®Google Scholar