Evaluation of preservative effectiveness in pharmaceutical products: the use of a wild strain of Pseudomonas cepacia.
A sodium benzoate-sorbic acid preservative system of a pharmaceutical product was proved effective against a wild strain of Pseudomonas cepacia, following the official method of the Italian and British Pharmacopoeias. However, this preservative system was ineffective against a challenge of Ps. cepacia wild strain cells grown in the unpreserved pharmaceutical product and on culture media different from those described by the Pharmacopoeias. The adaptive resistance of the wild strain of Ps. cepacia was not demonstrated with a laboratory strain (ATCC 25609). In contrast, p-hydroxybenzoate-based preservative systems proved to be efficient in protecting the pharmaceutical product against a challenge of wild and laboratory strains of Ps. cepacia grown in the different conditions described above. The results obtained suggest the usefulness, in the official methods for testing pharmaceutical preservatives, of using wild microbial strains isolated from the pharmaceutical environment. Metabolic adaptive responses, capable of affecting the antimicrobial sensitivity of wild micro-organisms used to challenge the preserved product, can be detected by using cells grown in the unpreserved pharmaceutical product.
Zani
F
F
Dipartimento Farmaceutico, Universitá di Parma, Italy.
Minutello
A
A
Maggi
L
L
Santi
P
P
Mazza
P
P
D001565:Benzoates / Q000494:pharmacology*; D019817:Benzoic Acid; D016956:Burkholderia cepacia / Q000187:drug effects* / Q000254:growth & development / Q000302:isolation & purification; D004341:Drug Evaluation; D004352:Drug Resistance, Microbial; D010226:Parabens / Q000494:pharmacology*; D011310:Preservatives, Pharmaceutical / Q000494:pharmacology*; D013011:Sorbic Acid / Q000494:pharmacology*; D013012:Sorbitol / Q000494:pharmacology; D013392:Sucralfate / Q000494:pharmacology
D001565:Benzoates; D010226:Parabens; D011310:Preservatives, Pharmaceutical; D013012:Sorbitol; D013392:Sucralfate; D019817:Benzoic Acid; C038193:4-hydroxybenzoic acid; D013011:Sorbic Acid