A design of experiments to optimize a new manufacturing process for high activity protein-containing submicron particles

References

• Tan ML, Choong PF, Dass CR. (2010). Recent developments in liposomes, microparticles and nanoparticles for protein and peptide drug delivery. Peptides, 31:184–193.
   PubMed Web of Science ®Google Scholar
• Morishita M, Peppas NA. (2006). Is the oral route possible for peptide and protein drug delivery? Drug Discov Today, 11:905–910.
   PubMed Web of Science ®Google Scholar
• Muller G. (2011). Oral delivery of protein drugs: driver for personalized medicine. Curr Issues Mol Biol, 13:13–24.
   PubMed Web of Science ®Google Scholar
• Singh R, Singh S, Lillard JW Jr. (2008). Past, present, and future technologies for oral delivery of therapeutic proteins. J Pharm Sci, 97:2497–2523.
   PubMed Web of Science ®Google Scholar
• Leader B, Baca QJ, Golan DE. (2008). Protein therapeutics: a summary and pharmacological classification. Nat Rev Drug Discov, 7:21–39.
   PubMed Web of Science ®Google Scholar
• Jitendra, Sharma PK, Bansal S, Banik A. (2011). Noninvasive routes of proteins and peptides drug delivery. Indian J Pharm Sci, 73:367–375.
   PubMed Web of Science ®Google Scholar
• Agu RU, Ugwoke MI, Armand M, Kinget R, Verbeke N. (2001). The lung as a route for systemic delivery of therapeutic proteins and peptides. Respir Res, 2:198–209.
   PubMed Web of Science ®Google Scholar
• Shoyele SA, Slowey A. (2006). Prospects of formulating proteins/peptides as aerosols for pulmonary drug delivery. Int J Pharm, 314:1–8.
   PubMed Web of Science ®Google Scholar
• Lochhead JJ, Thorne RG. (2012). Intranasal delivery of biologics to the central nervous system. Adv Drug Deliv Rev, 64:614–628.
   PubMed Web of Science ®Google Scholar
• Benson HA, Namjoshi S. (2008). Proteins and peptides: strategies for delivery to and across the skin. J Pharm Sci, 97:3591–3610.
   PubMed Web of Science ®Google Scholar
• Sudhakar Y, Kuotsu K, Bandyopadhyay AK. (2006). Buccal bioadhesive drug delivery–a promising option for orally less efficient drugs. J Control Release, 114:15–40.
   PubMed Web of Science ®Google Scholar
• Jahanshahi M, Babaei Z. (2008). Protein nanoparticle: A unique system as drug delivery vehicles. Afr J Biotechnol, 7:4926–4934
   Web of Science ®Google Scholar
• Kreuter J. (1995). Nanoparticulate systems in drug delivery and targeting. J Drug Target, 3:171–173.
   PubMed Web of Science ®Google Scholar
• Klibanov AM. (1997). Why are enzymes less active in organic solvents than in water? Trends Biotechnol, 15:97–101.
   PubMed Web of Science ®Google Scholar
• Scharnagl C, Reif M, Friedrich J. (2005). Stability of proteins: temperature, pressure and the role of the solvent. Biochim Biophys Acta, 1749:187–213.
   PubMed Web of Science ®Google Scholar
• Bell G, Halling PJ, Moore BD, Partridge J, Rees DG. (1995). Biocatalyst behaviour in low-water systems. Trends Biotechnol, 13:468–473.
   Web of Science ®Google Scholar
• Partridge J, Wallace DF, Raja KB, Dooley JS, Walker AP. (1998). Monocyte-macrophage ferric reductase activity is inhibited by iron and stimulated by cellular differentiation. Biochem J, 336 (Pt 3):541–543.
   PubMed Web of Science ®Google Scholar
• Partridge J, Moore BD, Lyle C. (2005). Antibody-coated microcrystals. AAPS J, 7:2894.
   Google Scholar
• Partridge J, Moore BD, Parker MC. (2005). Stabilization of proteins in the dry state without sugars. AAPS J, 7:2989.
   Google Scholar
• SHUGAR D. (1952). The measurement of lysozyme activity and the ultra-violet inactivation of lysozyme. Biochim Biophys Acta, 8:302–309.
   PubMed Web of Science ®Google Scholar
• Nikolic K, Murugesan M, Forshaw M, Cunningham D, Martinez-Albertos J-L, Moore BD. (2007). Self-assembly of nanoparticles on the surface of ionic crystals: Structural properties. Surf Sci, 601:2730–2734.
   Web of Science ®Google Scholar
• Murdan S, Somavarapu S, Ross AC, Alpar HO, Parker MC. (2005). Immobilisation of vaccines onto micro-crystals for enhanced thermal stability. Int J Pharm, 296:117–121.
   PubMedGoogle Scholar
• Kreiner M, Parker MC, Moore BD. (2001). Enzyme-coated micro-crystals: a 1-step method for high activity biocatalyst preparation. Chem Commun, 12:1096–1097.
   Google Scholar
• Morales JO, Ross AC, McConville JT. (2011). BSA microcrystals by a co-precipitation method: the effect of solvent type and presence of surfactant. AAPS J, 13:R6221.
   Google Scholar
• Johnson BK, Prud’homme RK. (2003). Chemical processing and micromixing in confined impinging jets. AIChE J, 49:2264–2282.
   Web of Science ®Google Scholar
• Morales JO, Ross AC, McConville JT. (2010). Manufacture of BSA microcrystals by a co-precipitation method. AAPS J, 12:T2059.
   Google Scholar
• Matteucci ME, Hotze MA, Johnston KP, Williams RO 3rd. (2006). Drug nanoparticles by antisolvent precipitation: mixing energy versus surfactant stabilization. Langmuir, 22:8951–8959.
   PubMed Web of Science ®Google Scholar
• Kreiner M, Fuglevand G, Moore BD, Parker MC. (2005). DNA-coated microcrystals. Chem Commun (Camb), 2675–2676.
   PubMed Web of Science ®Google Scholar
• Chen X, Matteucci ME, Lo CY, Johnston KP, Williams RO 3rd. (2009). Flocculation of polymer stabilized nanocrystal suspensions to produce redispersible powders. Drug Dev Ind Pharm, 35:283–296.
   PubMed Web of Science ®Google Scholar
• Rasenack N, Müller BW. (2002). Dissolution rate enhancement by in situ micronization of poorly water-soluble drugs. Pharm Res, 19:1894–1900.
   PubMed Web of Science ®Google Scholar
• Sinswat P, Gao X, Yacaman MJ, Williams RO 3rd, Johnston KP. (2005). Stabilizer choice for rapid dissolving high potency itraconazole particles formed by evaporative precipitation into aqueous solution. Int J Pharm, 302:113–124.
   PubMed Web of Science ®Google Scholar
• Miller MA, DiNunzio J, Matteucci ME, Ludher BS, Williams RO, Johnston KP. (2012). Flocculated amorphous itraconazole nanoparticles for enhanced in vitro supersaturation and in vivo bioavailability. Drug Dev Ind Pharm, 38:557–570.
   PubMed Web of Science ®Google Scholar
• Calvo P, Gouritin B, Chacun H, Desmaële D, D’Angelo J, Noel JP et al. (2001). Long-circulating PEGylated polycyanoacrylate nanoparticles as new drug carrier for brain delivery. Pharm Res, 18:1157–1166.
   PubMed Web of Science ®Google Scholar
• Lode J, Fichtner I, Kreuter J, Berndt A, Diederichs JE, Reszka R. (2001). Influence of surface-modifying surfactants on the pharmacokinetic behavior of 14C-poly (methylmethacrylate) nanoparticles in experimental tumor models. Pharm Res, 18:1613–1619.
   PubMed Web of Science ®Google Scholar
• Tiyaboonchai W, Tungpradit W, Plianbangchang P. (2007). Formulation and characterization of curcuminoids loaded solid lipid nanoparticles. Int J Pharm, 337:299–306.
   PubMed Web of Science ®Google Scholar
• Schubert MA, Müller-Goymann CC. (2005). Characterisation of surface-modified solid lipid nanoparticles (SLN): influence of lecithin and nonionic emulsifier. Eur J Pharm Biopharm, 61:77–86.
   PubMed Web of Science ®Google Scholar
• Jores K, Mehnert W, Drechsler M, Bunjes H, Johann C, Mäder K. (2004). Investigations on the structure of solid lipid nanoparticles (SLN) and oil-loaded solid lipid nanoparticles by photon correlation spectroscopy, field-flow fractionation and transmission electron microscopy. J Control Release, 95:217–227.
   PubMed Web of Science ®Google Scholar
• Zhang D. (2009). Sorbitan Esters (Sorbitan Fatty Acid Esters). In: Rowe RC, Sheskey PJ, Quinn ME, editors. Handbook of Pharmaceutical Excipients. New York: Pharmaceutical Press, 675–678.
   Google Scholar
• Gupta RB. (2006). Fundamentals of drug nanoparticles. In: Gupta RB, Kompella UB, editors. Nanoparticle Technology for Drug Delivery. New York: Taylor & Francis, 1–19.
   Google Scholar