Stability of 10 mg/mL cefuroxime solution for intracameral injection in commonly used polypropylene syringes and new ready-to-use cyclic olefin copolymer sterile vials using the LC-UV stability-indicating method

References

• European Society of Cataract and Refractive Surgeons (ESCRS). Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. J Cataract Refract Surg 2007;33:978–88
   PubMed Web of Science ®Google Scholar
• Barry P. Adoption of intracameral antibiotic prophylaxis of endophthalmitis following cataract surgery: update on the ESCRS Endophthalmitis Study. J Cataract Refract Surg 2014;40:138–42
   PubMed Web of Science ®Google Scholar
• Chang DF, Braga-Mele R, Mamalis N, et al. Prophylaxis of postoperative endophthalmitis after cataract surgery: results of the 2007 ASCRS member survey. J Cataract Refract Surg 2007;33:1801–5
   PubMed Web of Science ®Google Scholar
• Rudnisky CJ, Wan D, Weis E. Antibiotic choice for the prophylaxis of post-cataract extraction endophthalmitis. Ophthalmology 2014;121:835–41
   PubMed Web of Science ®Google Scholar
• Olavi P. Ocular toxicity in cataract surgery because of inaccurate preparation and erroneous use of 50mg/ml intracameral cefuroxime. Acta Ophthalmol 2012;90:e153–4
   PubMed Web of Science ®Google Scholar
• Viart H, Cueff R, Breysse C, et al. Optimisation of thawing conditions for solutions of cefuroxime in pre-filled syringes for intracameral injection to avoid a concentration gradient. Eur J Hosp Pharm Sci Pract 2012;20:117–21
   Google Scholar
• Verjans B. Using closed-vial technology in aseptic filling. Pharm Technol 2012;36:s36–s40
   Google Scholar
• Aseptic Technologies. Crystal®, the closed vial technology. Safer and easier aseptic filling. 2011. Available from: http://www.business-review-webinars.com/videos/c928f198c47145971fb27253b09485c3/aseptic.pdf [last accessed 22 Nov 2013]
   Google Scholar
• Verjans B, Reed C. Assessing filling technologies for contamination risks. Int BioPharm 2012;25:46–58
   Web of Science ®Google Scholar
• ANSM (Agence Nationale de sécurité du médicament et des produits de santé). Solution stérile de céfuroxime à 10mg/mL pour injection intracamérulaire. French National Formulary. [Internet]. 2010; Available from: http://ansm.sante.fr/Mediatheque/Publications/Pharmacopee-francaise-Formulaire-national [last accessed 24 Sept 2014]
   Google Scholar
• Piringer O-G, Baner AL. 2.3.1.7 Cyclic Olefin Copolymer (COC). Plastic packaging: interactions with food and pharmaceuticals. Weinheim Chichester: Wiley-VCH; 2008: 37–8
   Google Scholar
• Shin JY, Park JY, Liu C, et al. Chemical structure and physical properties of cyclic olefin copolymers (IUPAC Technical Report). Pure Appl Chem 2005;77:801–14
   Web of Science ®Google Scholar
• Wang W, Manmohan Singh, eds. Biological drug products: development and strategies. Hoboken (NJ): Wiley; 2014
   Google Scholar
• The European Medicines Agency (EMA). Summary of the European Public Assessment Report (EPAR) for Xeplion. [cited 22 Nov 2013]; Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002105/WC500103317.pdf
   Google Scholar
• SFPC, GERPAC. Methodological guidelines for stability studies of hospital pharmaceutical preparations. 2013. Available from: http://www.gerpac.eu/IMG/pdf/guide_stabilite_anglais.pdf [last accessed 24 Oct 2013]
   Google Scholar
• ICH (International Conference on Harmonisation). Harmonise tripartite guideline - stability testing of new drug substances and products Q1A(R2). 2003. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf [last accessed 24 Jul 2012]
   Google Scholar
• European Pharmacopoeia Commission. Monograph Cefuroxime sodium 8th ed (8.3). Strasbourg, France: EDQM; 2014: 1818--19
   Google Scholar
• Hubert P, Nguyen-Huu J-J, Boulanger B, et al. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal — part I. J Pharm Biomed Anal 2004;36:579–86
   PubMed Web of Science ®Google Scholar
• Hubert P, Nguyen-Huu J-J, Boulanger B, et al. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal–Part III. J Pharm Biomed Anal 2007;45:82–96
   PubMed Web of Science ®Google Scholar
• Hubert P, Nguyen-Huu J-J, Boulanger B, et al. Harmonization of strategies for the validation of quantitative analytical procedures: a SFSTP proposal–Part II. J Pharm Biomed Anal 2007;45:70–81
   PubMed Web of Science ®Google Scholar
• European Pharmacopoeia Commission. 2.6.1. Sterility 8th ed (8.3). Strasbourg, France: EDQM; 2014:175--8
   Google Scholar
• Wozniak TJ, Hicks JR. Cefuroxime sodium. In: Florey K, ed. Analytical profiles of drug substances, vol. 20. San Diego: Academic Press; 1991:209--36
   Google Scholar
• Fleury-Souverain S, Sadeghipour F, Bonnabry P. Development of ready-to-use cefuroxime syringes for use in ophthalmology. Eur J Hosp Pharm Sci Pract 2014;21:34–8
   Google Scholar
• Jain R, Wu Z, Bork O, et al. Pre-formulation and chemical stability studies of penethamate, a benzylpenicillin ester prodrug, in aqueous vehicles. Drug Dev Ind Pharm 2012;38:55–63
   PubMed Web of Science ®Google Scholar
• Dong J, Karki SB, Parikh M, et al. Oxidative degradation studies of an oxazolidinone-derived antibacterial agent, RWJ416457, in aqueous solutions. Drug Dev Ind Pharm 2012;38:1289–97
   PubMed Web of Science ®Google Scholar
• Uhart M, Pirot F, Boillon A, et al. Assessment of sodium hyaluronate gel as vehicle for intracameral delivery of cefuroxime in endophthalmitis prophylaxis. Int J Pharm 2010;398:14–20
   PubMed Web of Science ®Google Scholar
• Kodym A, Wiśniewski A, Kniola D, et al. Stability of cefuroxime in 1% and 5% buffered eye drops determined with HPLC method. Acta Pol Pharm 2010;68:555–64
   Web of Science ®Google Scholar
• Das Gupta V, Stewart KR. Stability of cefuroxime sodium in some aqueous buffered solutions and intravenous admixtures. J Clin Hosp Pharm 1986;11:47–54
   PubMedGoogle Scholar
• Muller HJ, Howe K, Frank C, et al. Stability of cefazolin, cefotiam, cefuroxime, cefotaxime, ceftriaxone and ceftazidime in normal saline solutions, stored in a new iv container made of Biofine®. Eur Hosp Pharm 2000;6:17–23
   Google Scholar
• Faouzi MA, Dine T, Luyckx M, et al. Stability and compatibility studies of cefaloridine, cefuroxime and ceftazidime with PVC infusion bags. Pharm 1994;49:425–7
   Google Scholar
• Paskiet D, Jenke D, Ball D, et al. The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP). PDA J Pharm Sci Technol PDA 2013;67:430–47
   PubMedGoogle Scholar
• Jenke D, Castner J, Egert T, et al. Extractables characterization for five materials of construction representative of packaging systems used for parenteral and ophthalmic drug products. PDA J Pharm Sci Technol PDA 2013;67:448–511
   PubMedGoogle Scholar
• Bittner GD, Denison MS, Yang CZ, et al. Chemicals having estrogenic activity can be released from some bisphenol a-free, hard and clear, thermoplastic resins. Environ Health Glob Access Sci Source 2014;13:103. doi:10.1186/1476-069X-13-103
   PubMed Web of Science ®Google Scholar
• Allwood MC. Practical guides I: Central intravenous additive services. J Clin Pharm Ther 1994;19:137–45
   PubMed Web of Science ®Google Scholar
• Hecq J-D. Centralized intravenous additive services (CIVAS): the state of the art in 2010. Ann Pharm Fr 2011;69:30–7
   PubMedGoogle Scholar