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April 2015

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Subject:
From:
Melissa Lambert <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 15 Apr 2015 22:33:14 +0000
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GSK CH has taken the following approaches;

For solid dosage with specific dosing instructions, let's say a 90 count bottle that instructs you to take 3 per day for a chronic condition.  If you follow dosing directions you would use the bottle within one month.
We would determine how many tablets were required for testing - let's say 70.
At time 0 would empty two bottles of 45 tablets and place in the chamber in the primary package (induction seal removed).
We would place an additional four bottles into the chamber with induction seal in place.
Over the course of the next 30 days we would open the two bottles 90 times each - if you work seven days a week you are opening them AM, noon and PM each day.  At the end of the 30 days you have two bottles with 45 tablets each to test.
Assuming a 24M expiry, we would repeat this process starting at 23M.
We would open two of the sealed bottles.  Remove 45 tablets and place back into the chamber.  We would open 90 days over the next 30 days and then test at expiry.
The additional two bottles are available if there was consideration to extend the expiry beyond 24M.

For solid dosage without specific dosing instructions, same 90 count bottle dosing is take as needed or specific dosing but for an acute conditions.  We would consult with our brand and marketing people to understand what the expected repurchase period is for the product.  What is a reasonable about of time to think someone would keep the product.  OR we might consider, how long do we thing the product will last.
If you don't expect the product to survive more than six months you would design a study similar to the above and label the bottle "discard 6M after opening".
If you expect the product to be used within three months you would design a study similar to the above.

To mitigate risk you could include additional periods...
Using the 90 count bottle and targeting three months in use period.
Six bottles are opened, 45 tablets removed and placed in chambers at T0.
Six to twelve sealed bottles also go in for end of expiry.
The first two are opened 90 times during the 1M, 3 x per day. Test at 1M.
The next two are opened 90 times over 2M, 3 x every other day.  Test at 2M.
The final two are opened 90 times over 3M, 1 x per day. Test at 3M
You would take two bottles at 21M and remove 45 tablets, open 90 x over 3M.  Test at 24M.
Two bottles at 22M and remove 45 tablets, open 90 x over 2M. Test at 24M.
Two bottles at 23M and remove 45 tablets, open 90 x over 1M.  Test at 24M.

We empty the bottle 1/2 way 1) so that we have adequate sample left at the end of the study 2) it is less labor intensive than to actually remove a tablet from each bottle and 3) the amount of headspace over the period of exposure averages out as thought you started removing one tablet and ended with one tablet (but doing this would require 70 bottles and a great deal of resource).

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Forenzo, Patrick
Sent: Wednesday, April 01, 2015 7:48 AM
To: [log in to unmask]
Subject: [PSDGLIST] In Use Test for solids

Can anyone share their program for in use test of solids in multiple use packs (ie HDPE bottles containing 30 units)- there is no clear guidance on how to perform the test and I am looking for some sort of industry standard companies are using- for example remove 1 tablet a day for 20 days (leaving 10 tablets in the bottle) , store for an additional 10 days opening the bottle once a day- (total test time 30 days) and then test the remaining samples or remove 1 tablet a day from bottle a and move into bottle b (empty) until all 30 units have been moved from bottle a to bottle b- perform the testing on the units in bottle b


Patrick Forenzo
Senior Fellow / Stability Expert
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA

Phone     +1  862 7786690
Cell        + 1  201 7047992
Fax         +1  973 7812019
[log in to unmask]<mailto:[log in to unmask]>
www.novartis.com<http://www.novartis.com/>



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=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors 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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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