The stability of lyophilized lipid/DNA complexes during prolonged storage

Journal of Pharmaceutical Sciences

Volumn 93, Issue 9, 2004, Pages 2259-2273

  Molina, Marion D C ^a   Armstrong, Taylor K ^a   Zhang, Ye ^a   Patel, Mayank M ^a   Lentz, Yvonne K ^a   Anchordoquy, Thomas J ^a  

^a UNIVERSITY OF COLORADO   (United States)

Author keywords

Cationic lipids; Dehydration; DNA; Gene delivery; Lyophilization; Nonviral vectors; Reactive oxygen species; Storage stability

Indexed keywords

DNA; DYE; ETHIDIUM BROMIDE; EXCIPIENT; GLUCOSE; LIPID; REACTIVE OXYGEN METABOLITE; SUCROSE; TREHALOSE;

ANIMAL CELL; ARTICLE; CELL STRAIN COS7; CHEMICAL PARAMETERS; CONTROLLED STUDY; DEHYDRATION; DNA DRUG COMPLEX; DNA SUPERCOILING; DRUG FORMULATION; DRUG MANUFACTURE; DRUG STABILITY; DRUG STORAGE; FLUORESCENCE ANALYSIS; FREEZE DRYING; GENETIC TRANSFECTION; GLASS TRANSITION TEMPERATURE; LOW TEMPERATURE; MOISTURE; NONHUMAN; NONVIRAL GENE DELIVERY SYSTEM; PARTICLE SIZE; PHYSICAL CHEMISTRY; PHYSICAL PARAMETERS; STORAGE TEMPERATURE; TIME; ZETA POTENTIAL;

EID: 4344610685     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1002/jps.20138     Document Type: Article

References (59)

1. Felgner PL, Gadek TR, Holm M, Roman R, Chan HW, et al. 1987. Lipofection - A highly efficient, lipid-mediated DNA transfection procedure. Proc Natl Acad Sci USA 87:7413-7417.
2. Felgner PL. 1997. Nonviral strategies for gene therapy. Sci Am 276:102-106.
3. Caplen NJ, Alton EWFW, Middleton PG, Dorin JR, Stevinson BJ, et al. 1995. Liposome-mediated CTFR gene transfer to the nasal epithelium of patients with cystic fibrosis. Nat Med 1:39-46.
4. Boussif O, Zanta MA, Behr J-P. 1996. Optimized galenics improve in vitro gene transfer with cationic molecules up to 1000-fold. Gene Ther 3: 1074-1080.
5. Godbey WT, Wu KK, Mikos AG. 1999. Poly(ethyleneimine) and its role in gene delivery. J Cont Rel 60:149-160.
6. Nguyen H-K, Lemieux P, Vinogradov SV, Gebhart CL, Guerin N, Paradis G, Bronich TK, Alakhov VY, Kabanov AV. 2000. Evaluation of polyether- polyethyleneimine graft copolymers as gene transfer agents. Gene Ther 7:126-138.
7. Gustafsson J, Arvidson G, Karlsson G, Almgren M. 1995. Complexes between cationic liposomes and DNA visualized by cryo-TEM. Biochim Biophys Acta 1235:305-312.
8. Dunlap DD, Maggi A, Soria MR, Monaco L. 1997. Nanoscopic structure of DNA condensed for gene delivery. Nucleic Acids Res 25:3095-3101.
9. Tang MX, Szoka FC. 1997. The influence of polymer structure on the interactions of cationic polymers with DNA and morphology of the resulting complexes. Gene Ther 4:823-832.
10. Mahato RI, Rolland A, Tomlinson E. 1997. Cationic lipid-based gene delivery systems: Pharmaceutical perspectives. Pharm Res 14:853-859.
11. Anchordoquy TJ, Koe GS. 2000. Physical stability of nonviral plasmid-based therapeutics. J Pharm Sci 89:289-296.
12. Mahato RI. 1999. Non-viral peptide-based approaches to gene delivery. J Drug Target 7: 249-268.
13. Anchordoquy TJ, Girouard LG, Carpenter JF, Kroll DJ. 1998. Stability of lipid/DNA complexes during agitation and freeze-thawing. J Pharm Sci 87: 1046-1051.
14. Middaugh CR, Evans RK, Montgomery DL, Casimiro DR. 1998. Analysis of plasmid DNA from a pharmaceutical perspective. J Pharm Sci 87: 130-146.
15. Anchordoquy TJ, Carpenter JF, Kroll DJ. 1997. Maintenance of transfection rates and physical characterization of lipid/DNA complexes after freeze-drying and rehydration. Arch Biochem Biophys 348:199-206.
16. Allison SD, Anchordoquy TJ. 2000. Mechanisms of protection of cationic lipid-DNA complexes during lyophilization. J Pharm Sci 89:682-691.
17. Cherng J-Y, van de Wetering P, Talsma H, Crommelin DJA, Hennink WE. 1997. Freeze-drying of poly((2-dimethylamino)ethyl methacrylate)-based gene delivery systems. Pharm Res 14: 1838-1841.
18. Talsma H, Cherng JY, Lehrmann H, Kursa M, Ogris W, et al. 1997. Stabilization of gene delivery systems by freeze-drying. Int J Pharm 157:233-238.
19. Cherng J-Y, Talsma H, Crommelin DJA, Hennink WE. 1999. Long term stability of Poly((2-dimethylamino) ethyl methacrylate)-based gene delivery systems. Pharm Res 16:1417-1423.
20. Cherng J-Y, Wetering Pvd, Talsma H, Crommelin DJA, Hennink WE. 1999. Stabilization of polymer-based gene delivery systems. Int J Pharm 183: 25-28.
21. Allison SD, Molina MdC, Anchordoquy TJ. 2000. Stabilization of lipid/DNA complexes during the freezing step of the lyophilization process: The particle isolation hypothesis. Biochim Biophys Acta 1468:127-138.
22. Li B, Li S, Tan Y, Stolz DB, Watkins SC, et al. 2000. Lyophilization of cationic lipid-protamine-DNA (LPD) complexes. J Pharm Sci 89:355-364.
23. Molina MdC, Allison DS, Anchordoquy TJ. 2001. Maintenance of particle size during the freezing step of the lyophilization process is insufficient for preservation of activity: Insight from other structural indicators. J Pharm Sci 90:1445-1455.
24. Seville PC, Kellaway IW, Birchall JC. 2002. Preparation of dry powder dispersions for non-viral gene delivery by freeze-drying and spray-drying. J Gene Med 4:428-437.
25. Allison SD, Anchordoquy TJ. 2001. Lyophilization of nonviral gene delivery systems. In: Findeis M, editor. Nonviral vectors for gene therapy. Totowa, NJ: Humana Press.
26. Eastman SJ, Siegel C, Tousignant J, Smith AE, Cheng SH, Scheule RK. 1997. Biophysical characterization of cationic lipid:DNA complexes. Biochim Biophys Acta 1325:41-62.
27. Lloyd RS, Haidle CW, Robberson DL. 1978. Bleomycin-specific fragmentation of double-stranded DNA. Biochemistry 17:1890-1896.
28. May JC, Grim E, Wheeler RM, West J. 1982. Determination of residual moisture in freeze-dried viral vaccines: Karl Fischer, gravimetric, and thermogravimetric methodologies. J Biol Stand 10:249-259.
29. Pou S, Huang Y-I, Bhan A, Bhadti VS, Hosmane RS, et al. 1993. A fluorophore-containing nitroxide as a probe to detect superoxide and hydroxyl radical generated by stimulated neutrofils. Anal Biochem 212:85-90.
30. Anchordoquy TJ. 1999. Nonviral gene delivery systems: Physical stability. Bio Pharm 12:42-48.
31. Cortesi R, Esposito E, Nastruzzi C. 2000. Effect of DNA complexation and freeze-drying on the physico-chemical characteristics of cationic liposomes. Antisense Nucleic Acid Dev 10:205-215.
32. Kwok KY, Adami RC, Hester KC, Park Y, Thomas S, Rice KG. 2000. Strategies for maintaining the particle size of peptide DNA condensates following freeze-drying. Int J Pharm 203:81-88.
33. Hanna N, Peri KG, Abran D, Hardy P, Doke A, et al. 1997. Light induces peroxidation in retina by activating prostaglandin G/H synthase. Free Rad Biol Med 23:885-897.
34. Lindahl T, Nyberg B. 1972. Rate of depurination of native deoxyribonucleic acid. Biochemistry 11: 3610-3617.
35. Lindahl T, Andersson A. 1972. Rate of chain breakage at apurinic sites in double-stranded deoxyribonucleic acid. Biochemistry 11:3618-3623.
36. Pikal K, Shah S. 1991. Moisture transfer from topper to product and resulting stability implications. Dev Biol Stand 74:165-179.
37. Karmas R, Buera P, Karel M. 1992. Effect of glass transition on rates of nonenzymatic browning in food systems. J Agric Food Chem 40:873-879.
38. Sun WQ, Davidson P, Chan HSO. 1998. Protein stability in the amorphous carbohydrate matrix: Relevance to anhydrobiosis. Biochim Biophys Acta 1425:245-254.
39. Buitink J, Hemminga MA, Hoekstra FA. 1999. Characterization of molecular mobility in seed tissues: An electron paramagnetic resonance spin probe study. Biophys J 76:3315-3322.
40. Buitink J, Leprince O, Hemminga MA, Hoekstra FA. 2000. Molecular mobility in the cytopplasm: An approach to describe and predict lifespan of dry germplasm. Proc Natl Acad Sci USA 97:2385-2390.
41. Craig ID, Parker R, Rigbi NM, Cairns P, Ring SG. 2001. Maillard reaction kinetics in model preservation systems in the vicinity of the glass transition: Experiment and theory. J Agric Food Chem 49: 4706-4712.
42. Pukacka S, Hoffmann SK, Goslar J, Pukacki PM, Wojkiewicz E. 2003. Water and lipid relations in beech (Fagus sylvatica L.) seeds and its effect on storage behavior. Biochim Biophys Acta 1621: 48-56.
43. Poxon SW, Hughes JA. 2000. The effect of lyophilization on plasmid DNA activity. Pharm Dev Technol 5:115-122.
44. Croyle MA, Cheng X, Wilson JM. 2001. Development of formulations that enhance physical stability of viral vectors for gene therapy. Gene Ther 8:1281-1290.
45. Hancock BC, Shamblin SL, Zografi G. 1995. Molecular mobility of amorphous pharmaceutical solids below their glass transition temperatures. Pharm Res 12:799-806.
46. Jahnig F, Bramhall J. 1982. The origin of a break in Arrhenius plots of membrane processes. Biochim Biophys Acta 690:310-313.
47. Bador H, Morelis R, Louisot P. 1984. Breaks in Arrhenius plots of reactions involving membrane-bound and solubilized sialyltransferases, due to temperature dependence of kinetic parameters. Biochim Biophys Acta 800:75-86.
48. Puterman ML, Hrboticky N, Innis SM. 1988. Nonlinear estimation of parameters in biphasic Arrhenius plots. Anal Biochem 170:409-420.
49. Hancock BC, Zografi G. 1997. Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 86:1-12.
50. Evans RK, Xu Z, Bohannon KE, Wang B, Brunner MW, Volkin DB. 2000. Evaluation of degradation pathways for plasmid DNA in pharmaceutical formulations via accelerated stability studies. J Pharm Sci 89:76-87.
51. Netto LES, Ferreira AM, Augusto O. 1991. Iron(III) binding in DNA solutions: Complex formation and catalytic activity in the oxidation of hydrazine derivatives. Chem Biol Interact 79:1-14.
52. Toyokuni S, Sagripanti J-L. 1992. Ion-mediated DNA damage: Sensitive detection of DNA strand breakage catalyzed by iron. Inorg Biochem 47: 241-248.
53. Koltover I, Salditt T, Radler JO, Safinya CR. 1998. An inverted hexagonal phase of cationic liposome-DNA complexes related to DNA release and delivery. Science 281:78-81.
54. Shalaev EY, Steponkus PL. 1999. Phase diagram of 1,2- dioleoylphosphatidylethanolamine (DOPE): water system at subzero temperatures and at low water contents. Biochim Biophys Acta 1419:229-247.
55. Shalaev EY, Steponkus PL. 2001. Phase behavior and glass transition of 1,2-dioleoylphatidylethanolamine (DOPE) dehydrated in the presence of sucrose. Biochim Biophys Acta 1514:100-116.
56. Weiland B, Huttermann J. 1998. Free radicals from X-irradiated dry and hydrated lyophilized DNA as studied by electron spin resonance spectroscopy: Analysis of spectral components between 77K and room temperature. Int J Radiat Biol 74:341-358.
57. Becker D, Bryant-Friedrich A, Trzasko C, Sevilla MD. 2003. Electron spin resonance study of DNA with an argon-ion beam: Evidence for formation of sugar phosphate backbone radicals. Radiat Res 160:174-185.
58. Caffrey M. 1985. Kinetics and mechanism of the lamellar gel/lamellar liquid-crystal and lamellar/inverted hexagonal phase transition in phosphatidylethanolamine: A real-time X-ray diffraction study using synchrotron radiation. Biochemistry 24:4826-4844.
59. Cherezov V, Qiu H, Pector V, Vanderbranden M, Ruysschaert J-M. 2002. Biophysical and transfection studies of the di-C14-Amidine/DNA complex. Biophys J 82:3105-3117.