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March 2013

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Subject:
From:
"Mr. Steve Brown" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 6 Mar 2013 16:42:17 -0500
Content-Type:
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In my experience, although, In-Use studies are required by some
Regulatory Authorities, there is little true guidance on exactly how to
do them.

We ran into a similar situation, but with a solid oral dosage form in a
100-count package.  The required testing called for a pooled sample of
20 dosage units (any sample size requirement must be taken into
consideration).

Since, the product must not be stored outside the package (stated on the
label) and the dose was 1 tablet a day; our approach was to initially
open the container, remove 20 dosage units and test them for base-line
data and to maximize the container head-space.  Then, we simulated the
"worst-case" in-use conditions by manipulating the container (opened it
for 1-minute and then closed it) every working-day (Monday thru Friday);
but, did not remove any dosage units.  We did this for 20 calendar-days.
On the 20th day, we removed another 20 dosage units and tested them.
This was repeated until all dosage units were consumed.

Your approach seems reasonable; especially, if the sample you need for
testing is about 14 mL.

Steven W. Brown, R.Ph.
Sr. VP Regulatory Affairs

Time-Cap Labs, Inc.
7 Michael Avenue
Farmingdale NY 11735
631-753-9090 ext 122

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-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Balasuriya, Tila
Sent: Wednesday, March 06, 2013 9:20 AM
To: [log in to unmask]
Subject: [PSDGLIST] In-Use testing

Team,

Would anyone have any experience with conducting In-Use stability
studies for an oral  liquid formulation  such as a syrup, to indicate
how close to the daily dosing you have to mirror the in-use stability
study.
For example if the daily dose is 2mls once per day, would it be
acceptable to design the In-Use stability study to remove 14mls (1
week's supply)  aliquots from a bottle once a week.

If you are aware of any ICH guidances, or regulatory experiences etc,
please let me know Thanks Tila Balasuriya






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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
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chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
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supplies
    for the clinical, industrial, and molecular biology research
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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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