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

Drug Development and Industrial Pharmacy

Volumn 39, Issue 11, 2013, Pages 1793-1801

  Morales, Javier O ^a   Joks, Gero M ^b   Lamprecht, Alf ^b   Ross, Alistair C ^c   McConville, Jason T ^a,d  

^a UNIVERSITY OF TEXAS AT AUSTIN   (United States)

^b UNIVERSITY OF BONN   (Germany)

^c Controlled Therapeutics ^*  (United Kingdom)

^d UNIVERSITY OF NEW MEXICO   (United States)

Author keywords

Bovine serum albumin; Design of experiments; Enzyme activity; Lysozyme; Peptide submicron particles; Protein submicron particles

Indexed keywords

BOVINE SERUM ALBUMIN; LYSOZYME; PEPTIDE; PROTEIN; VALINE;

AQUEOUS SOLUTION; ARTICLE; CHEMICAL MODEL; DRUG FORMULATION; DRUG MANUFACTURE; MICROTECHNOLOGY; NEBULIZER; PARTICLE SIZE; PRECIPITATION; PROCESS DESIGN; PROCESS OPTIMIZATION; PROTEIN INTERACTION; SURFACE PROPERTY; ULTRASOUND;

ANIMALS; CATTLE; CHEMICAL PRECIPITATION; DRUG CARRIERS; DRUG COMPOUNDING; DRUG STABILITY; EXCIPIENTS; HEXOSES; MICROSCOPY, ELECTRON, SCANNING; MODELS, MOLECULAR; MURAMIDASE; PARTICLE SIZE; POLYSORBATES; PROTEIN STABILITY; QUALITY CONTROL; SERUM ALBUMIN, BOVINE; SOLUBILITY; SONICATION; SURFACE PROPERTIES; SURFACE-ACTIVE AGENTS; VALINE;

EID: 84877575979     PISSN: 03639045     EISSN: 15205762     Source Type: Journal    
DOI: 10.3109/03639045.2012.737332     Document Type: Article

References (39)

1. Tan ML, Choong PF, Dass CR. (2010). Recent developments in liposomes, microparticles and nanoparticles for protein and peptide drug delivery. Peptides, 31:184-193
2. Morishita M, Peppas NA. (2006). Is the oral route possible for peptide and protein drug delivery? Drug Discov Today, 11:905-910
3. Muller G. (2011). Oral delivery of protein drugs: Driver for personalized medicine. Curr Issues Mol Biol, 13:13-24
4. 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
5. Leader B, Baca QJ, Golan DE. (2008). Protein therapeutics: A summary and pharmacological classification. Nat Rev Drug Discov, 7:21-39
6. Jitendra, Sharma PK, Bansal S, Banik A. (2011). Noninvasive routes of proteins and peptides drug delivery. Indian J Pharm Sci, 73:367-375
7. 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
8. Shoyele SA, Slowey A. (2006). Prospects of formulating proteins/ peptides as aerosols for pulmonary drug delivery. Int J Pharm, 314:1-8
9. Lochhead JJ, Thorne RG. (2012). Intranasal delivery of biologics to the central nervous system. Adv Drug Deliv Rev, 64:614-628
10. Benson HA, Namjoshi S. (2008). Proteins and peptides: Strategies for delivery to and across the skin. J Pharm Sci, 97:3591-3610
11. 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
12. Jahanshahi M, Babaei Z. (2008). Protein nanoparticle: A unique system as drug delivery vehicles. Afr J Biotechnol, 7:4926-4934
13. Kreuter J. (1995). Nanoparticulate systems in drug delivery and targeting. J Drug Target, 3:171-173
14. Klibanov AM. (1997). Why are enzymes less active in organic solvents than in wateróf Trends Biotechnol, 15:97-101
15. Scharnagl C, Reif M, Friedrich J. (2005). Stability of proteins: Temperature, pressure and the role of the solvent. Biochim Biophys Acta, 1749:187-213
16. Bell G, Halling PJ, Moore BD, Partridge J, Rees DG. (1995). Biocatalyst behaviour in low-water systems. Trends Biotechnol, 13:468-473
17. 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 (PT3):541-543
18. Partridge J, Moore BD, Lyle C. (2005). Antibody-coated microcrystals. AAPS J, 7:2894
19. Partridge J, Moore BD, Parker MC. (2005). Stabilization of proteins in the dry state without sugars. AAPS J, 7:2989
20. SHUGAR D. (1952). The measurement of lysozyme activity and the ultra-violet inactivation of lysozyme. Biochim Biophys Acta, 8:302-309
21. 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
22. 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
23. Kreiner M, Parker MC, Moore BD. (2001). Enzyme-coated microcrystals: A 1-step method for high activity biocatalyst preparation. Chem Commun, 12:1096-1097
24. 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
25. Johnson BK, Prudhomme RK. (2003). Chemical processing and micromixing in confined impinging jets. AIChE J, 49:2264-2282
26. Morales JO, Ross AC, McConville JT. (2010). Manufacture of BSA microcrystals by a co-precipitation method. AAPS J, 12:T2059
27. Matteucci ME, Hotze MA, Johnston KP, Williams RO 3rd. (2006). Drug nanoparticles by antisolvent precipitation: Mixing energy versus surfactant stabilization. Langmuir, 22:8951-8959
28. Kreiner M, Fuglevand G, Moore BD, Parker MC. (2005). DNA-coated microcrystals. Chem Commun (Camb), 2675-2676
29. 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
30. Rasenack N, Müller BW. (2002). Dissolution rate enhancement by in situ micronization of poorly water-soluble drugs. Pharm Res, 19:1894-1900
31. 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
32. 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
33. Calvo P, Gouritin B, Chacun H, Desmaüle D, DAngelo J, Noel JP et al. (2001). Long-circulating PEGylated polycyanoacrylate nanoparticles as new drug carrier for brain delivery. Pharm Res, 18:1157-1166
34. 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
35. Tiyaboonchai W, Tungpradit W, Plianbangchang P. (2007). Formulation and characterization of curcuminoids loaded solid lipid nanoparticles. Int J Pharm, 337:299-306
36. 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
37. 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
38. 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
39. Gupta RB. (2006). Fundamentals of drug nanoparticles. In: Gupta RB, Kompella UB, editors. Nanoparticle Technology for Drug Delivery. New York: Taylor & Francis, 1-19