News & events

Bailey Rubin, Technical Sales Representative

A preparation has already undergone stability testing, but the container is changing. This may involve changes to the container’s material composition, size, or packaging configuration.

If the formulation hasn’t changed, it may seem reasonable to assume the stability data still apply, right?

Not necessarily.

During stability testing, it is essential to evaluate the container. The formulation, storage conditions, and packaging all interact, so changes to the final packaging can affect the applicability of existing stability data.

Why does the container matter?

The container does more than hold the preparation; it also plays a crucial role in protection. The container can also interact with the formulation in ways that may impact its stability. Factors such as the container material, type, size, and closure can influence the preparation’s stability over time.

Both USP <797> and ICH stability guidance recognize that stability data should represent the product in the packaging in which it will actually be stored and dispensed. USP <797> considers the container’s materials and compatibility with the final preparation when establishing a BUD, and ICH recommends using the same formulation and the same, or simulated, container closure system proposed for storage and distribution.

If stability data is obtained from one packaging type, changing to a different packaging type does not automatically mean the existing stability data applies.

What if only the container size or fill volume is changing?

The container size and fill volume matter.

ICH allows bracketing for different container sizes or fill volumes when they are part of the same container closure system. However, different sizes or fill volumes can change characteristics that may affect stability, such as headspace or the amount of formulation in contact with the container surface.

For example, changes in headspace can affect the amount of oxygen available to the formulation, which may be critical for preparations susceptible to oxidation. Similarly, changes in the surface-area-to-volume ratio can affect how much of the formulation is in contact with the container material.

What should be done before changing the packaging?

Before making a change, compare the container used during the original stability study to the container planned for use. Consider what has changed and whether those differences could affect the stability of the preparation.

If it is unclear whether existing stability data supports a change in final packaging, or if a packaging change is being considered and additional testing may be needed, contact ARL Bio Pharma at info@arlok.com. The ARL Bio Pharma team can help determine the appropriate next steps at info@arlok.com or 800-393-1595.