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August 2019

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From:
"Mazzeo (R&D), Tony" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 9 Aug 2019 14:18:32 +0000
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Hi Gina,
   I believe that 'general rule' is based on the Arrhenius equations set up for 2 different temperatures (you can find the equation form in physical chemistry and pharmaceutical texts) and it uses a 'generic' activation energy that tries to cover every common reaction type.  It's been used in the past but it's really ballparkish and that's what the 1 month will get you 4 months from.  Depending on the amount of risk involved you may be OK using that rule.  You can get a bit more accurate if you use an activation energy that better represents your shelf life limiting degradation reaction.  Eg. For oxidation reactions use a reasonable oxidation activation energy.
These days, companies are getting more sophisticated and using 'predictive stability modeling' based on Arrhenius and other types of models.  You might take a look at FreeThink website and the ideas and publications behind "ASAP Prime".  I don't use the software myself and don't mean to advertise - but they have a lot of published examples.
Also, in case you this is for a clinical trial application in the EU - note that they allow 1 gives 4 but no more than 12 months extension for small molecules and it's less for biologics.

All ideas are my own and not necessarily those of my employer.

Tony Mazzeo
BMS
New Brunswick

-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Gina Mathews
Sent: Friday, August 9, 2019 12:56 AM
To: [log in to unmask]
Subject: [PSDGLIST] Arrhenius Question

Fellow Stabilitarians,

Has anyone seen a mathematical proof that 6 months of storage at 40C/75%RH should equal 24 months of storage at 25C/60%RH?  Supposedly this is derived from the Arrhenius equation.  Does anyone know how this works?  Would 3 months of storage at 40C/75%RH therefore equal 12 months at 25C/60%RH?


Best regards,

Gina Mathews
Sr. Manager, Stability, Quality Control
[cid:image003.jpg@01D54E34.1D5D0900]
Heron Therapeutics
4242 Campus Point Court, Suite 200
San Diego, CA 92121
O: 858-251-4712
[log in to unmask]

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ScienTek - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.iStability.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7Ca5eaefe057c14d1b1a0808d71ccd80f8%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637009541276474895&amp;sdata=8aehPuuo17G%2BZWxqbMJ9LH5r%2BWScNy0NBp%2BW6If4%2FiE%3D&amp;reserved=0
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

Avista Pharma Solutions - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.avistapharma.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7Ca5eaefe057c14d1b1a0808d71ccd80f8%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637009541276474895&amp;sdata=HvRpYFOFsUkqiF3TR7Nvn5Ost1JYr5jLaBa7NJFdJAw%3D&amp;reserved=0
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.

BahnsonEnvironmental Specialties - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.eschambers.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7Ca5eaefe057c14d1b1a0808d71ccd80f8%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637009541276484884&amp;sdata=fufwPr98v45XDC39W33jFx5egoGBcZXQp2xvSIuUp0w%3D&amp;reserved=0
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.cszindustrial.com%2F&amp;data=02%7C01%7Ctony.mazzeo%40BMS.COM%7Ca5eaefe057c14d1b1a0808d71ccd80f8%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637009541276484884&amp;sdata=RW6Q2i7YOj40GuOknvuyTx0s3mRfcSrzSIJXNhTdOTc%3D&amp;reserved=0
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.
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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.


ScienTek - http://www.iStability.com/
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.

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

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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