Dose Response Model Of Mouthwash Case Study
Application of dose response model for infection on selected case of oral mouth wash product
Mostafa Essam Eissa*
Quality Control Department, Microbiology Laboratory Division
*Corresponding e-mail: mostafaessameissa@yahoo.com
Running Title: Infection model of mouthwash
HIKMA Pharma pharmaceutical company, P.O. Box 1913, 2nd Industrial Zone, Plot no.1, 6th of October City, Giza, Egypt, Mobile: 00201006154853.
Abstract
Microbial contamination of pharmaceutical products constitutes a great concern for stakeholders and professionals in the field. Special attention is brought to multidose medicinal products with considerable water activities (aw). Such pharmaceutical products are prone to microbial spoilage with serious consequences on patients’
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(1971)
Table 2. Preservative efficacy test (PET) results of selected pharmaceutical products based on USP, 2010.
Dosage Form Test Microorganisms Testing Days Antimicrobial Components
Antiseptic mouth wash solution S. aureus* >3.40 >3.40 Hexetidine and Ethanol 96%
E. coli* >3.00 >3.00 P. aeruginosa* >3.30 >3.30 B. cepacia*,ψ >3.07 >3.07 C. albicans* >3.70 >3.70 A. brasiliensis 0.25 1.50
* = Microorganisms that have not been recovered at any stage of the test from the recovery medium. ψ = Non-pharmacopeial, water-borne isolate was included in the study of the products from facilities from which this microorganism was found.
Table 3. Infection risk expressed as percent from repeated contamination with each maximum dose/frequency administration using exponential dose-response model of Escherichia
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