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Stability of fortified cefazolin ophthalmic solutions prepared in artificial tears containing surfactant-based versus oxidant-based preservatives.
J Ocul Pharmacol Ther 2010; 26(5):485-90JO

Abstract

OBJECTIVE

The aim of this study was to investigate the stability of fortified cefazolin sodium ophthalmic solutions (50 mg mL⁻¹) extemporaneously prepared in commercial artificial tears containing 2 different types of preservatives, namely the surfactants and oxidants.

METHODS

Fortified cefazolin sodium solutions were prepared by reconstituting cefazolin for injection with sterile water and further diluted with Tears Naturale II or Natear, 2 commercial artificial tears containing polyquaternium-1 and sodium perborate, respectively, as preservatives. The solutions were then kept at room temperature (28°C) or in the refrigerator (4°C). During the 28-day period, the formulations were periodically examined for the physical appearance, pH, and the remaining drug concentrations. The antibacterial potency was evaluated as the minimal inhibitory concentration against Staphylococcus aureus strain ATCC 29923 by broth dilution technique. The activity of the preservatives was demonstrated by antimicrobial effectiveness tests. On day 28, the microbial contamination in the preparations was tested.

RESULTS

The stability profiles of cefazolin solutions prepared in Tears Naturale II, Natear, and water were not different, but they were significantly influenced by the storage temperature. The refrigerated formulations showed no loss of drug and antibacterial potency as well as alteration of physical appearance and pH throughout the 28 days. In contrast, those kept at room temperature showed gradual change in color and odor. The degradation of drug exceeded 10% from day 3 and the decrease of antibacterial potency could be observed at week 3. All cefazolin solutions prepared in artificial tears retained the antimicrobial activity of preservatives and were free from bacterial and fungal contamination throughout the 28-day period of study.

CONCLUSIONS

Cefazolin sodium ophthalmic solutions can be extemporaneously prepared in Tears Naturale II or Natear without the influence from different types of preservatives used in these vehicles. The formulation is physically and chemically stable and retains the antibacterial potency for at least 28 days in the refrigerator.

Authors+Show Affiliations

Faculty of Pharmacy, Silpakorn University , Nakhon Pathom, Thailand. teerasak@su.ac.thNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

20879806

Citation

Rojanarata, Theerasak, et al. "Stability of Fortified Cefazolin Ophthalmic Solutions Prepared in Artificial Tears Containing Surfactant-based Versus Oxidant-based Preservatives." Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics, vol. 26, no. 5, 2010, pp. 485-90.
Rojanarata T, Tankul J, Woranaipinich C, et al. Stability of fortified cefazolin ophthalmic solutions prepared in artificial tears containing surfactant-based versus oxidant-based preservatives. J Ocul Pharmacol Ther. 2010;26(5):485-90.
Rojanarata, T., Tankul, J., Woranaipinich, C., Potawanich, P., Plianwong, S., Sakulma, S., & Saehuan, C. (2010). Stability of fortified cefazolin ophthalmic solutions prepared in artificial tears containing surfactant-based versus oxidant-based preservatives. Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics, 26(5), pp. 485-90. doi:10.1089/jop.2010.0036.
Rojanarata T, et al. Stability of Fortified Cefazolin Ophthalmic Solutions Prepared in Artificial Tears Containing Surfactant-based Versus Oxidant-based Preservatives. J Ocul Pharmacol Ther. 2010;26(5):485-90. PubMed PMID: 20879806.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stability of fortified cefazolin ophthalmic solutions prepared in artificial tears containing surfactant-based versus oxidant-based preservatives. AU - Rojanarata,Theerasak, AU - Tankul,Junlathip, AU - Woranaipinich,Chayanee, AU - Potawanich,Paweena, AU - Plianwong,Samarwadee, AU - Sakulma,Sirinart, AU - Saehuan,Choedchai, PY - 2010/10/1/entrez PY - 2010/10/1/pubmed PY - 2011/3/29/medline SP - 485 EP - 90 JF - Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics JO - J Ocul Pharmacol Ther VL - 26 IS - 5 N2 - OBJECTIVE: The aim of this study was to investigate the stability of fortified cefazolin sodium ophthalmic solutions (50 mg mL⁻¹) extemporaneously prepared in commercial artificial tears containing 2 different types of preservatives, namely the surfactants and oxidants. METHODS: Fortified cefazolin sodium solutions were prepared by reconstituting cefazolin for injection with sterile water and further diluted with Tears Naturale II or Natear, 2 commercial artificial tears containing polyquaternium-1 and sodium perborate, respectively, as preservatives. The solutions were then kept at room temperature (28°C) or in the refrigerator (4°C). During the 28-day period, the formulations were periodically examined for the physical appearance, pH, and the remaining drug concentrations. The antibacterial potency was evaluated as the minimal inhibitory concentration against Staphylococcus aureus strain ATCC 29923 by broth dilution technique. The activity of the preservatives was demonstrated by antimicrobial effectiveness tests. On day 28, the microbial contamination in the preparations was tested. RESULTS: The stability profiles of cefazolin solutions prepared in Tears Naturale II, Natear, and water were not different, but they were significantly influenced by the storage temperature. The refrigerated formulations showed no loss of drug and antibacterial potency as well as alteration of physical appearance and pH throughout the 28 days. In contrast, those kept at room temperature showed gradual change in color and odor. The degradation of drug exceeded 10% from day 3 and the decrease of antibacterial potency could be observed at week 3. All cefazolin solutions prepared in artificial tears retained the antimicrobial activity of preservatives and were free from bacterial and fungal contamination throughout the 28-day period of study. CONCLUSIONS: Cefazolin sodium ophthalmic solutions can be extemporaneously prepared in Tears Naturale II or Natear without the influence from different types of preservatives used in these vehicles. The formulation is physically and chemically stable and retains the antibacterial potency for at least 28 days in the refrigerator. SN - 1557-7732 UR - https://www.unboundmedicine.com/medline/citation/20879806/Stability_of_fortified_cefazolin_ophthalmic_solutions_prepared_in_artificial_tears_containing_surfactant_based_versus_oxidant_based_preservatives_ L2 - https://www.liebertpub.com/doi/full/10.1089/jop.2010.0036?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -