Dear Patrick,
In a previous lifetime, I remember doing something similar to your first example, since this study design was aligned with the label instructions of once daily dosing for that particular product. As you propose, we also continued to open the bottles till the last date of dosing (day 30 in your example) and tested what was left in the bottle, since the test is supposed to demonstrate that the product in the package, after opening and repeated dispensing, is good to use till the last day of the in-use or dispensing period ("good till the last drop"). Study designs usually will vary based on the difference in label dosing instructions, as you are supposed to simulate how the patient/customer will handle the package and product. Open dish (petri dish or unsealed bottle) data may also be used to support the in-use period, since this condition represents worst case product exposure.
The CPMP (EU) guidance is an excellent reference. In addition, the WHO 2009 Stability Guidance contains a section on in-use stability that reflects the EU requirements.
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003475.pdf
http://www.who.int/medicines/publications/pharmprep/pdf_trs953.pdf?ua=1#page=101
Warm regards and best of luck!
Jing
Jing Capucao, Ph. D.
R&D Stability Manager
McNeil Consumer Healthcare
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215-273-2441
-----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.
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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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