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March 2012

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From:
Jelena Peric <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 8 Mar 2012 22:02:37 -0800
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I will rely on the data from the entire formulated product - that should be and will be the main part of the AET.
 
I only thought that additional tests may be necessary in order to provide additional information and to justify the choice of the preservative and its concentration.
 
 
 
 

From: "[log in to unmask]" <[log in to unmask]>
To: [log in to unmask] 
Sent: Thursday, March 8, 2012 5:55 PM
Subject: Re: [PMFLIST] Antimicrobial efficacy

I assume you perform AET in stability to confirm your?projections on efficacy and preservative concentration and perform relevant testing to assure active ingredient - antibiotic - stability as well.??? As you're ?objective is protection of the product, why you would not rely on data from the?entire formulated product rather than attempt to isolate preservatve from antibotic?




-----Original Message-----
From: Jelena Peric &lt;[log in to unmask]&gt;
To: PMFLIST &lt;[log in to unmask]&gt;
Sent: Thu, Mar 8, 2012 10:49 am
Subject: [PMFLIST] Antimicrobial efficacy




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 PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

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

Accugenix - http://www.accugenix.com

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

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

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

Lonza Rapid Testing Solutions - http://www.lonza.com/rts

MicroBioLogics, Inc. - http://www.microbiologics.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

Veltek Associates, Inc - http://www.sterile.com

=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

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

Accugenix - http://www.accugenix.com

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

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

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

Lonza Rapid Testing Solutions - http://www.lonza.com/rts

MicroBioLogics, Inc. - http://www.microbiologics.com

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

Veltek Associates, Inc - http://www.sterile.com

=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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