Abstract
Validation of Symmetrical Two-Dose Parallel Line Assay Model for Nystatin Potency Determination in Pharmaceutical Product
Highlights
The potency of the antibiotics can be demonstrated under adequately controlled conditions through their inhibitory characteristic over microbial proliferation[1]
Agar diffusion is one of the biological methods that are more commonly employed for antibiotic dosage
The agar diffusion technique relies on the antimicrobial entity dispersion in the matrix of a layer of solidified agar medium, to the extent that completely suppresses the proliferation of the microbial cells in an area or zone around the reservoir containing antibiotic solution[6]
Summary
The potency (activity) of the antibiotics can be demonstrated under adequately controlled conditions through their inhibitory characteristic over microbial proliferation[1]. The agar diffusion technique relies on the antimicrobial entity dispersion in the matrix of a layer of solidified agar medium, to the extent that completely suppresses the proliferation of the microbial cells in an area or zone around the reservoir containing antibiotic solution[6] In this type of assay, the diameter (size) of the inhibition zone and the dose of the substance assayed are directly correlated 7. The solution of the test material is applied on the surface of this medium in a confined space, which is usually sterile plates incubated: the microorganism growth occurs, respecting the areas in which the antibiotic diffusion has occurred, generating contrast and resulting in the so-called growth inhibition zone 10 This phenomenon is the basic of the all theory that is the fundamental of the diffusion technique
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