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Vol. 47, No. 4, 2001
Issue release date: July–August 2001
Chemotherapy 2001;47:304–308
(DOI:10.1159/000048538)

Evaluation of Spontaneous Contamination of Ocular Medications

Marchese A. · Bozzolasco M. · Gualco L. · Schito G.C. · Debbia E.A.
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Abstract

Background: In order to evaluate whether single-dose ophthalmic preparations in 0.5-ml containers can safely be used within 24 h after the first opening, eigth different sterile ocular medications containing timolol, jaluronic acid, diclofenac, ketotifen, pilocarpine, formocortal, formocortal-gentamycin, and tetryzoline-feniramine (Farmigea, Italy) were opened and tested for spontaneous bacterial contamination after exposure to air. Methods: Samples (10 µl) were collected from exposed ophthalmic preparations after 0, 2, 4, 8 and 24 h. Results: No viable microorganisms were detected during and at the end of the evaluation period. In order to assess whether the resident or pathogenic ocular bacterial population due to repeated handling might contaminate the medications, about 105 cells of different species (Staphylococcus aureus, coagulase-negative staphylococci, Streptococcus pneumoniae, Streptococcus spp., Corynebacterium spp., Pseudomonas aeruginosa, Neisseria spp., Acinetobacter spp., Haemophilus influenzae, Escherichia coli and Candida albicans) were added to the containers and incubated at 37°C or at room temperature. Samples were collected and the number of viable bacteria was estimated. The antibacterial effect of the ophthalmic compounds varied depending on the species considered. Tetryzoline-feniramine, pilocarpine, ketotifen and formocortal-gentamycin exhibited a frank bactericidal activity (<100 survivors after 18–24 h of exposure) against the great majority of the species tested. Conclusion: These results indicate that the risk of spontaneous contamination of ophthalmic preparations after their first opening is low, and that all preparations tested exhibit an aspecific antibacterial activity. As a consequence, the safe usage of these ocular medications could be extended from the recommended 3 h to at least 24 h after the first usage.



Copyright / Drug Dosage

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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References

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  2. Schein OD, Hibberd PL, Starch T, Baker AS, Kenyon KR: Microbial contamination of in-use ocular medications. Arch Ophthalmol 1992;110:82–85.

    External Resources

  3. Høding G, Sjursen H: Bacterial contamination of drops and dropper tips of in use multidose eye drop bottles. Acta Ophthalmol 1982;60:213–222.

    External Resources

  4. European Pharmacopoeia, 1998. Annex to the ICH/CPMP note for guidance on stability testing of new active substances and medical products (CPMP/ICH/380/95): Maximum shelf-life for sterile products after first opening or following reconstitution.
  5. National Committee for Clinical Laboratory Standards: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, ed 4. Approved Standard M7-A5 (2000) and M100-S10 (2000). Wayne, NCCLS, 2000.
  6. Van Santvliet L, Sam T, Ludwig A: Packing of ophthalmic solutions – Influence on stability, sterility, eye drop instillation and patient compliance. Eur J Pharm Biopharm 1996;42:375–384.
  7. Craig WA, Gudmundsson S: Postantibiotic effect; in Lorian V (ed): Antibiotics in Laboratory Medicine. Baltimore, Williams & Wilkins, 1996, pp 296–329.


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