Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All, 
I am working with a CMO to develop a drug and they are getting ready to put it on stability. Does the size of the pill bottle the product is contained in matter? 

For example, I may want to send one pill for a study in a year from now and put it in a small bottle, versus using the drug for a trial and sending it for a larger trial. Which do I use for stability?

Thank you,

Dear Anon,

The purpose of stability is to evaluate the container/closure system with the product at various conditions (ICH) to characterize the "stability" of the product to inform labeled storage, transportation as intended in the clinical setting or take home.  Not sure if you have any feasibility studies, degradation or impurity profile in various containers/conditions? This could be useful. However,  I would say that without data, impact of the size of the container is an unknown.  Will the pill with additional head space or cotton to prevent breakage impact the physical and chemical properties of the product.  From a scientific perspective I would place a pill in both configurations and "bracket" the container size.  In either case you will need stability in the small bottle and then in the large bottle to support the filings and justify labeling, storage etc.   This is the least risk scenario. 

I look forward to other input and perspective on this topic, 

Good luck,

Dar

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
------------------------------

Original Message:
Sent: 11-May-2022 11:27
From: Anonymous Member
Subject: Drug Product Stability - Pill Bottle Size

This message was posted by a user wishing to remain anonymous

Hi All,
I am working with a CMO to develop a drug and they are getting ready to put it on stability. Does the size of the pill bottle the product is contained in matter?

For example, I may want to send one pill for a study in a year from now and put it in a small bottle, versus using the drug for a trial and sending it for a larger trial. Which do I use for stability?

Thank you,

This message was posted by a user wishing to remain anonymous

Thanks very much. Do you have any input on batch size? How many pills need to go into the pill bottle? This is for clinical trials, so we may be sending a different number of pills to each site. 

Thank you, 

Original Message:
Sent: 12-May-2022 00:28
From: Darlene Rosario
Subject: Drug Product Stability - Pill Bottle Size

Dear Anon,

The purpose of stability is to evaluate the container/closure system with the product at various conditions (ICH) to characterize the "stability" of the product to inform labeled storage, transportation as intended in the clinical setting or take home.  Not sure if you have any feasibility studies, degradation or impurity profile in various containers/conditions? This could be useful. However,  I would say that without data, impact of the size of the container is an unknown.  Will the pill with additional head space or cotton to prevent breakage impact the physical and chemical properties of the product.  From a scientific perspective I would place a pill in both configurations and "bracket" the container size.  In either case you will need stability in the small bottle and then in the large bottle to support the filings and justify labeling, storage etc.   This is the least risk scenario.

I look forward to other input and perspective on this topic,

Good luck,

Dar

------------------------------
Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States

Original Message:
Sent: 11-May-2022 11:27
From: Anonymous Member
Subject: Drug Product Stability - Pill Bottle Size

This message was posted by a user wishing to remain anonymous

Hi All,
I am working with a CMO to develop a drug and they are getting ready to put it on stability. Does the size of the pill bottle the product is contained in matter?

For example, I may want to send one pill for a study in a year from now and put it in a small bottle, versus using the drug for a trial and sending it for a larger trial. Which do I use for stability?

Thank you,

Yes. Bottle size does matter as differences in headspace could impact stability. Suggest conducting stability studies on the lowest and highest number of tablets you intend to use in your studies.  Then you will be bracketing for any tablet count in between.  You may also want to consider a small bottle for the smaller tablet counts.

------------------------------
Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
------------------------------

Original Message:
Sent: 11-May-2022 11:27
From: Anonymous Member
Subject: Drug Product Stability - Pill Bottle Size

This message was posted by a user wishing to remain anonymous

Hi All,
I am working with a CMO to develop a drug and they are getting ready to put it on stability. Does the size of the pill bottle the product is contained in matter?

For example, I may want to send one pill for a study in a year from now and put it in a small bottle, versus using the drug for a trial and sending it for a larger trial. Which do I use for stability?

Thank you,