Evaluation of preservative systems in opthalmic suspension of polymyxin B and dexamethasone by linear regression.
An ophthalmic suspension of polymyxin B and dexametasone with 13 different preservative systems was evaluated by a linear regression method for rapid screening, using D-values. The products were challenged against Pseudomonas aeruginosa, Burkholderia cepacia, Staphylococcus aureus, Candida albicans and Aspergillus niger. Since linear regression showed correlation coefficients higher than 0.84 the decimal reduction time (D-value) was then calculated. The comparison of D-values obtained for each microorganism and each product led to the selection of the formula 9 = 10, which was selected to be submitted to the efficacy of antimicrobial preservation according to the European Pharmacopoeia.
Bou-Chacra
N A
NA
Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, Brasil.
Pinto
T J A
TJ
Kaneko
T M
TM
D000900:Anti-Bacterial Agents / Q000737:chemistry*; D000890:Anti-Infective Agents / Q000494:pharmacology*; D001419:Bacteria / Q000187:drug effects; D003907:Dexamethasone / Q000737:chemistry*; D004492:Edetic Acid / Q000737:chemistry; D005658:Fungi / Q000187:drug effects; D016014:Linear Models; D008826:Microbial Sensitivity Tests; D009883:Ophthalmic Solutions; D011112:Polymyxin B / Q000737:chemistry*; D011310:Preservatives, Pharmaceutical / Q000494:pharmacology*; D015203:Reproducibility of Results; D013242:Sterilization; D013535:Suspensions
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D013535:Suspensions; D003907:Dexamethasone; D004492:Edetic Acid; D011112:Polymyxin B