Achieving long-term stability of lipid nanoparticles: Examining the effect of pH, temperature, and lyophilization

International Journal of Nanomedicine

Volumn 12, Issue , 2017, Pages 305-315

  Lball, Rebecca ^a   Bajaj, Palak ^a   Whitehead, Kathryn A ^a  

^a CARNEGIE MELLON UNIVERSITY   (United States)

Author keywords

Lipid nanoparticles; Lyophilization; Lyoprotectants; Nanoparticle stability; Nanoparticle storage; SiRNA delivery

Indexed keywords

ALCOHOL; BUFFER; CRYOPROTECTIVE AGENT; DEIONIZED WATER; LIPIDOID NANOPARTICLE; NANOPARTICLE; SMALL INTERFERING RNA; SUCROSE; TREHALOSE; UNCLASSIFIED DRUG; LIPID;

AQUEOUS SOLUTION; ARTICLE; CONTROLLED STUDY; DIALYSIS; FREEZE DRYING; FREEZE THAWING; HELA CELL LINE; MOLECULAR STABILITY; PARTICLE SIZE; PH; PHYSICAL CHEMISTRY; REDUCTION (CHEMISTRY); REFRIGERATION; ROOM TEMPERATURE; STORAGE TEMPERATURE; TEMPERATURE; CHEMISTRY; DRUG DELIVERY SYSTEM; DRUG STABILITY; FREEZING; HUMAN;

CRYOPROTECTIVE AGENTS; DRUG DELIVERY SYSTEMS; DRUG STABILITY; FREEZE DRYING; FREEZING; HELA CELLS; HUMANS; HYDROGEN-ION CONCENTRATION; LIPIDS; NANOPARTICLES; RNA, SMALL INTERFERING; SUCROSE; TEMPERATURE; TREHALOSE;

EID: 85010023309     PISSN: 11769114     EISSN: 11782013     Source Type: Journal    
DOI: 10.2147/IJN.S123062     Document Type: Article

References (41)

1. Whitehead KA, Dorkin JR, Vegas AJ, et al. Degradable lipid nanoparticles with predictable in vivo siRNA delivery activity. Nat Commun. 2014;5:4277.
2. Whitehead KA, Matthews J, Chang PH, et al. In vitro-in vivo translation of lipid nanoparticles for hepatocellular siRNA delivery. ACS Nano. 2012;6(8):6922-6929.
3. Ball RL, Knapp CM, Whitehead KA. Lipidoid nanoparticles for siRNA delivery to the intestinal epithelium: in vitro investigations in a Caco-2 model. PLoS One. 2015;10(7):e0133154.
4. Love KT, Mahon KP, Christopher G, et al. Lipid-like materials for low-dose, in vivo gene silencing. Proc Natl Acad Sci U S A. 2010;107(5):1864-1869.
5. Kasiewicz LN, Whitehead KA. Silencing TNFα with lipidoid nanoparticles downregulates both TNFα and MCP-1 in an in vitro co-culture model of diabetic foot ulcers. Acta Biomater. 2015;32:120-128.
6. Turnbull IC, Eltoukhy AA, Fish KM, et al. Myocardial delivery of lipidoid nanoparticle carrying modRNA induces rapid and transient expression. Mol Ther. 2015;24(1):66-75.
7. Knapp CM, He J, Lister J, Whitehead KA. Lipidoid nanoparticle mediated silencing of Mcl-1 induces apoptosis in mantle cell lymphoma. Exp Biol Med (Maywood). 2016;241(9):1007-1013.
8. Knapp CM, Guo P, Whitehead KA. Lipidoid tail structure strongly influences siRNA delivery activity. Cell Mol Bioeng. 2016;9(3):305-314.
9. Aso Y, Yoshioka S. Effect of freezing rate on physical stability of lyophilized cationic liposomes. Chem Pharm Bull. 2005;53(3):301-304.
10. Maitani Y, Aso Y, Yamada A, Yoshioka S. Effect of sugars on storage stability of lyophilized liposome/DNA complexes with high transfection efficiency. Int J Pharm. 2008;356(1-2):69-75.
11. Torchilin V, Weissig V. Liposomes: A Practical Approach. OUP Oxford, New York; 2003.
12. Chen C, Han D, Cai C, Tang X. An overview of liposome lyophilization and its future potential. J Control Release. 2010;142(3):299-311.
13. Stark B, Pabst G, Prassl R. Long-term stability of sterically stabilized liposomes by freezing and freeze-drying: effects of cryoprotectants on structure. Eur J Pharm Sci. 2010;41(3-4):546-555.
14. Del Pozo-Rodríguez A, Solinís MA, Gascón AR, Pedraz JL. Short-and long-term stability study of lyophilized solid lipid nanoparticles for gene therapy. Eur J Pharm Biopharm. 2009;71(2):181-189.
15. Kasper JC, Winter G, Friess W. Recent advances and further challenges in lyophilization. Eur J Pharm Biopharm. 2013;85(2):162-169.
16. Wang L, Hu X, Shen B, et al. Enhanced stability of liposomes against solidification stress during freeze-drying and spray-drying by coating with calcium alginate. J Drug Deliv Sci Technol. 2015;30:163-170.
17. Yin F, Guo S, Gan Y, Zhang X. Preparation of redispersible liposomal dry powder using an ultrasonic spray freeze-drying technique for transdermal delivery of human epithelial growth factor. Int J Nanomedicine. 2014;9(1):1665-1675.
18. Campardelli R, Trucillo P, Reverchon E. A supercritical fluid-based process for the production of fluorescein-loaded liposomes. Ind Eng Chem Res. 2016;55(18):5359-5365.
19. Radmanovic N, Serno T, Joerg S, Germershaus O. Understanding the freezing of biopharmaceuticals: first principle modeling of the process and evaluation of its effect on product quality. J Pharm Sci. 2013;102(8):2495-2507.
20. Fonte P, Soares S, Costa A, et al. Effect of cryoprotectants on the porosity and stability of insulin-loaded PLGA nanoparticles after freeze-drying. Biomatter. 2012;2(4):329-339.
21. Hengherr S, Heyer AG, Köhler HR, Schill RO. Trehalose and anhydrobiosis in tardigrades-evidence for divergence in responses to dehydration. FEBS J. 2008;275(2):281-288.
22. Dey A, Cederbaum AI. Alcohol and oxidative liver injury. Hepatology. 2006;43:63-74.
23. Watanabe T, Umehara T, Yasui F, et al. Liver target delivery of small interfering RNA to the HCV gene by lactosylated cationic liposome. J Hepatol. 2007;47(6):744-750.
24. Dahlman JE, Barnes C, Khan OF, et al. In vivo endothelial siRNA delivery using polymeric nanoparticles with low molecular weight. Nat Nanotechnol. 2014;9(8):648-655.
25. Baba M, Itaka K, Kondo K, Yamasoba T, Kataoka K. Treatment of neurological disorders by introducing mRNA in vivo using polyplex nanomicelles. J Control Release. 2015;201:41-48.
26. Anchordoquy TJ, Girouard LG, Carpenter JF, Kroll DJ. Stability of lipid/DNA complexes during agitation and freeze-thawing. J Pharm Sci. 1998;87(9):1046-1051.
27. Felgner PL, Tsai YJ, Sukhu L, et al. Improved cationic lipid formulations for in vivo gene therapy. Ann N Y Acad Sci. 1995;772:126-139.
28. Abdelwahed W, Degobert G, Stainmesse S, Fessi H. Freeze-drying of nanoparticles: formulation, process and storage considerations. Adv Drug Deliv Rev. 2006;58(15):1688-1713.
29. Wu SY, Putral LN, Liang M, Chang HI, Davies NM, McMillan NA. Development of a novel method for formulating stable siRNA-loaded lipid particles for in vivo use. Pharm Res. 2009;26(3):512-522.
30. Kundu AK, Chandra PK, Hazari S, et al. Stability of lyophilized siRNA nanosome formulations. Int J Pharm. 2012;423(2):525-534.
31. Fonte P, Araújo F, Seabra V, Reis S, Van De Weert M, Sarmento B. Co-encapsulation of lyoprotectants improves the stability of protein-loaded PLGA nanoparticles upon lyophilization. Int J Pharm. 2015;496(2):850-862.
32. Shu X, Zhu K. The influence of multivalent phosphate structure on the properties of ionically cross-linked chitosan films for controlled drug release. Eur J Pharm Biopharm. 2002;54(2):235-243.
33. Van de Graaf KM. Anatomy and physiology of the gastrointestinal tract. Pediatr Infect Dis. 1986;5(1):S11-S15.
34. Date PV, Samad A, Devarajan PV. Freeze thaw: a simple approach for prediction of optimal cryoprotectant for freeze drying. AAPS PharmSciTech. 2010;11(1):304-313.
35. Kasper JC, Friess W. The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm. 2011;78(2):248-263.
36. Hinrichs WLJ, Mancenido FA, Sanders NN, et al. The choice of a suitable oligosaccharide to prevent aggregation of PEGylated nanoparticles during freeze thawing and freeze drying. Int J Pharm. 2006;311(1-2):237-244.
37. Khatri N, Baradia D, Vhora I, Rathi M, Misra A. Development and characterization of siRNA lipoplexes: effect of different lipids, in vitro evaluation in cancerous cell lines and in vivo toxicity study. AAPS PharmSciTech. 2014;15(6):1630-1643.
38. Hayashi H. Drying Technologies of Foods-Their History and Future. Drying Technology. 1989;7(2):315-369.
39. Carpenter JF, Chang BS, Garzon-Rodriguez W, Randolph TW. Rational design of stable protein formulations. Pharm Biotechnol. 2002;13:109-133.
40. Chang HI, Yeh MK. Clinical development of liposome-based drugs: formulation, characterization, and therapeutic efficacy. Int J Nanomedicine. 2012;7:49-60.
41. Ohtake S, Wang YJ. Trehalose: current use and future applications. J Pharm Sci. 2011;100(6):2020-2053.