Silicone oil microdroplets and protein aggregates in repackaged bevacizumab and ranibizumab: Effects of long-term storage and product mishandling

Investigative Ophthalmology and Visual Science

Volumn 52, Issue 2, 2011, Pages 1023-1034

  Liu, Lu ^a   Ammar, David A ^b   Ross, Lindsey A ^a   Mandava, Naresh ^b   Kahook, Malik Y ^b   Carpenter, John F ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; MONOMER; PLACEBO; RANIBIZUMAB; SILICONE OIL; ANGIOGENESIS INHIBITOR; MONOCLONAL ANTIBODY;

ARTICLE; CONTROLLED STUDY; DRUG CONTAMINATION; DRUG PACKAGING; DRUG STORAGE; FREEZE THAWING; GEL PERMEATION CHROMATOGRAPHY; MATERIALS HANDLING; MECHANICAL STRESS; PARTICLE SIZE; PRIORITY JOURNAL; PROTEIN AGGREGATION; CHEMISTRY; DRUG FORMULATION; DRUG STABILITY; PARTICULATE MATTER; PROTEIN MULTIMERIZATION;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL; DRUG COMPOUNDING; DRUG PACKAGING; DRUG STABILITY; DRUG STORAGE; PARTICLE SIZE; PARTICULATE MATTER; PROTEIN MULTIMERIZATION; SILICONE OILS;

EID: 79953266988     PISSN: 01460404     EISSN: 15525783     Source Type: Journal    
DOI: 10.1167/iovs.10-6431     Document Type: Article

References (23)

1. Subramanian ML, Ness S, Abedi G, et al. Bevacizumab vs. ranibizumab for age-related macular degeneration: early results of a prospective double-masked, randomized clinical trial. Am J Ophthalmol. 2009;148:875-882 e871.
2. Jyothi S, Chowdhury H, Elagouz M, Sivaprasad S. Intravitreal bevacizumab (Avastin) for age-related macular degeneration: a critical analysis of literature. Eye (Lond). 2010;24:816-824.
3. Manzano RP, Peyman GA, Khan P, Kivilcim M. Testing intravitreal toxicity of bevacizumab (Avastin). Retina. 2006;26:257-261.
4. Rich RM, Rosenfeld PJ, Puliafito CA, et al. Short-term safety and efficacy of intravitreal bevacizumab (Avastin) for neovascular agerelated macular degeneration. Retina. 2006;26:495-511.
5. Chang TS, Kokame G, Casey R, Prenner J, Feiner L, Anderson N. Short-term effectiveness of intravitreal bevacizumab versus ranibizumab injections for patients with neovascular age-related macular degeneration. Retina. 2009;29:1235-1241.
6. NEI. Comparison of AMD Treatments Trials (CATT): Lucentis-Avastin Trial; 2010.
7. Good TJ, Kimura AE, Mandava N, Kahook MY. Sustained elevation1 of intraocular pressure after intravitreal injections of anti-VEGF agents. Br J Ophthalmol. Published online August 11, 2010.
8. Ness T, Feltgen N, Agostini H, Bohringer D, Lubrich B. Toxic vitreitis outbreak after intravitreal injection. Retina. 2010;30:332-338.
9. Yamashiro K, Tsujikawa A, Miyamoto K, et al. Sterile endophthalmitis after intravitreal injection of bevacizumab obtained from a single batch. Retina. 2010;30:485-490.
10. Artunay O, Yuzbasioglu E, Rasier R, Sengul A, Bahcecioglu H. Incidence and management of acute endophthalmitis after intravitreal bevacizumab (Avastin) injection. Eye (Lond). 2009;23:2187-2193.
11. Kahook MY, Kimura AE, Wong LJ, Ammar DA, Maycotte MA, Mandava N. Sustained elevation in intraocular pressure associated with intravitreal bevacizumab injections. Ophthalmic Surg Lasers Imaging. 2009;40:293-295.
12. Jalil A, Fenerty C, Charles S. Intravitreal bevacizumab (Avastin) causing acute glaucoma: an unreported complication. Eye (Lond). 2007;21:1541.
13. Bakri SJ, Larson TA, Edwards AO. Intraocular inflammation following intravitreal injection of bevacizumab. Graefes Arch Clin Exp Ophthalmol. 2008;246:779-781.
14. Kahook MY, Liu L, Ruzycki P, et al. High-molecular-weight aggregates in repackaged bevacizumab. Retina. 2010;30:887-892.
15. Sharma DK Oma P, Krishnan S. Silicone microdroplets in protein formulations detection and enumeration. Pharm Technol 2009;33: 74-79.
16. Scott IU, Oden NL, VanVeldhuisen PC, Ip MS, Blodi BA, Antoszyk AN. SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design. Am J Ophthalmol. 2009;148:725-732. e727.
17. Wen ZQ, Vance A, Vega F, Cao X, Eu B, Schulthesis R. Distribution of silicone oil in prefilled glass syringes probed with optical and spectroscopic methods. PDA J Pharm Sci Technol. 2009;63:149-158.
18. Crampton S, Ricci M. Development and Application of a Fourier Transform Infrared (FTIR) Spectroscopy Method to Quantify Silicone Oil Extracted from Syringes. AAPS National BioTechnology. Conference. San Francisco: The American Association of Pharmaceutical Scientists; 2010.
19. Ludwig DB, Carpenter JF, Hamel JB, Randolph TW. Protein adsorption and excipient effects on kinetic stability of silicone oil emulsions. J Pharm Sci. 2010;99:1721-1733.
20. Thirumangalathu R, Krishnan S, Ricci MS, Brems DN, Randolph TW, Carpenter JF. Silicone oil- and agitation-induced aggregation of a monoclonal antibody in aqueous solution. J Pharm Sci. 2009; 98:3167-3181.
21. Bakri SJ, McCannel CA, Edwards AO, Moshfeghi DM. Persistent ocular hypertension following intravitreal ranibizumab. Graefes Arch Clin Exp Ophthalmol. 2008;246:955-958.
22. Ichhpujani P, Jindal A, Jay Katz L. Silicone oil induced glaucoma: a review. Graefes Arch Clin Exp Ophthalmol. 2009;247: 1585-1593.
23. Kahook MY, Ammar DA. In vitro effects of antivascular endothelial growth factors on cultured human trabecular meshwork cells. J Glaucoma.