Antimicrobial Effectiveness in Eye Drops: Limited Sterility versus Reduction in Microbial Count.

Autor:	Abu Shaqra QM; ASMI Medica, Zarqa, Jordan; qabushaqra@hotmail.com., Al-Groom RM; Department of Nutrition, Al-Zarqa University College, Al-Balqa Applied University, As-Salt, Jordan; and., Abu Shaqra AQ; Abu Shaqra Medical Diagnostic Laboratory, Jabal Al-Hussein, Amman, Jordan.
Jazyk:	angličtina
Zdroj:	PDA journal of pharmaceutical science and technology [PDA J Pharm Sci Technol] 2020 May-Jun; Vol. 74 (3), pp. 309-317. Date of Electronic Publication: 2020 Jan 15.
DOI:	10.5731/pdajpst.2019.009845
Abstrakt:	Eye drops are sterile preparations intended for instillation into the eye. All major pharmacopoeias require these products to pass the antimicrobial effectiveness test (AET). This test is similar to that used for an oral dosage form despite the fact that both product categories differ in their microbiological specifications. The eye drops might pass the official requirements of the AET, but in practice, contaminants introduced into the preparation might not be killed before its next use by the patient and this may compromise ocular health. The objective of this work was to investigate the possible application of a limited sterility testing in a multichallenge test that mimics more closely real life use of eye drops. The AET was performed on 12 brands of eye drops, and results were compared with the suggested pass criteria of various pharmacopoeias. The multichallenge test was designed and used to demonstrate the ability of each tested product to kill the entire challenge organism population within a few hours. The results demonstrated that all products investigated complied with the AET acceptance requirements of the USP <51> and the "B" criteria of the European Pharmacopoeia (Ph Eur) <5.1.3>. Only two of the tested products did not comply with the no recovery term of Ph Eur <5.1.3> "A" criteria. Products repeatedly challenged with Pseudomonas aeruginosa ATCC 9027 (103 CFU/mL) were found to be self-sterilizing within 2 h of each inoculation. In conclusion, all tested products passed the acceptance criteria of the USP <51>, class B of the Ph Eur <5.1.3>, and the multichallenge test. The size of the challenge organism population in the AET seems to be severe for eye drops, and the pass criteria of the British Pharmacopoeia Appendix XVI are the most stringent. The no recovery term given in the Ph Eur <5.1.3> should be defined to a specified range. (© PDA, Inc. 2020.)
Databáze:	MEDLINE
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