Nmg. Desolis et al., EFFECT OF PLASMIDS CONFERRING PRESERVATIVE RESISTANCE ON PERFORMANCE OF BACTERIAL STRAINS IN COMPENDIAL PRESERVATIVE EFFICACY TESTS, European journal of pharmaceutical sciences, 2(3), 1994, pp. 221-228
R plasmids, which increased resistance of Staphylococcus aureus and Es
cherichia coli to a variety of pharmaceutical preservatives, were show
n, using the protocol of the Preservative Efficacy Test of the British
Pharmacopoeia (1988), to influence the antibacterial efficacy of 0.00
1% benzalkonium chloride, 0.001% cetrimide and 0.0001% phenyl mercuric
nitrate solutions, but not 0.0005% chlorhexidine gluconate. Some stra
ins, which failed the BP (1988) criteria for ophthalmic and parenteral
products, satisfied the less stringent A or B criteria of the BP (199
3). However, the death rates of all strains tested complied with the c
riteria of the BP (1988) for 0.003% benzalkonium chloride, 0.003% cetr
imide and 0.001% phenylmercurie nitrate solutions. The data illustrate
the undoubted effects R plasmids can have on the survival of bacteria
contaminating pharmaceutical products but suggest that the levels of
resistance conferred are not sufficient to affect, adversely; the acti
vities of in-use concentrations that are required by compendial preser
vative efficacy tests.