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March 2012

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Subject:
From:
Brian Matthews <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 8 Mar 2012 16:07:02 +0000
Content-Type:
text/plain
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text/plain (135 lines)
I suggest that you apply the standard test method.  The idea is that it
demonstrates the PET of the formulation as a whole.  Thus I would not worry
about the contribution from the preservative and from the other components
in the product.

In development tests you might also want to look separately at the
preservative/solvent 'placebo' to give you more information.

It is however important to continue the test and recovery to the
recommended periods - it is not unknown for surprises to happen towards the
end of the test!

Regards,

Brian Matthews.

On 8 March 2012 10:49, Jelena Peric <[log in to unmask]> wrote:

> Dear All,
>
>
> have you ever tested the antimicrobial efficacy (i.e. efficacy of
> antimicrobial preservation) according to EP 5.1.3., or USP, on an
> antibiotic oral solution, or in any other antibiotic preparation that
> contains preservatives in addition to the antibiotic?
>
> The test is usually used to demonstrate that the chosen preservative
> concentration in a product is effective. During developmental stages of a
> product, different probes with different preservative concentrations are
> usually tested in order to demonstrate that the choice of a
> preservative and its concentration is justified, and that the product still
> complies even if the preservative content drops for what ever reason during
> shelf life.
>
> In my case, the situation is more complicated because of the presence of
> the antibiotic. What would be the right experimental design in my case?
> The simplest way would be to do the test on the final formulation, and to
> claim that the product is adequately preserved - but by doing so, I would
> not find out which test microorganisms are inhibited by the preservative,
> and which ones by the antibiotic, and what happens if the content of any of
> the antimicrobial substances drops during shelf life.
>
> Maybe I should test the final product formulation with the targeted
> preservative concentration, and than the same formulation but with the
> preservative concentration lowered (for example, 80% of the targeted
> concentration). Maybe I should see what happens if the content of the
> antibiotic drops to 80%, or what happens in the placebo (without the
> antibiotic) with the targeted preservative concentration or the lowered
> preservative concentration...
> What would you do in this case?
>
> Any thoughts will be appreciated,
>
>
> Jelena
>
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the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

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American Type Culture Collection - http://www.atcc.org

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Biotest - http://www.BiotestUSA.com/micro

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Steris - http://www.sterislifesciences.com/

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