New USP Chapter on Moisture Barrier of Plastic Packaging Systems

Recommendation

7/8 May 2024

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The United States Pharmacopeia, USP, published a draft of a new general chapter in Pharmacopeial Forum (PF) 44(3) [May- June 2018]: <1671> The Application of Moisture Vapor Transmission Rates for Solid Oral Dosage Forms in Plastic Packaging Systems. This chapter is applicable to pharmaceutical manufacturers, packagers, and repackagers.

According to USP, the proposed new general chapter <1671> has been developed to support general chapter Containers—Performance Testing <671> which has been revised and published for comment in the same issue of PF.

The new chapter <1671> is intended to

• describe the methodology of proving the moisture barrier equivalency of two similar packaging systems based on the moisture vapor transmission rate (MVTR) measurements described in general chapter <671>;
• define the upper limit of the MVTR for an oral dosage form drug product (tablet, see below);
• compare the desiccant-based and water-based MVTR methods; and
• explain how to leverage MVTR data to complement, and possibly reduce, stability studies when a new packaging system or a new drug product packaging configuration is introduced.

The scope of this chapter is restricted to

• solid oral dosage form (SODF) drug products;
• MVTR based on Methods 1, 2, and 3 (desiccant-based) described in general chapter <671>;
• MVTR based on Method 4 (water based) described in <671>, and
• repackaging of SODFs.

A maximum demonstrated moisture permeability of ≤ 0.8 per day per tablet (MVTR/Unit) was established. The maximum demonstrated level of MVTR may be used in order to introduce new packaging presentations without the need of specific drug product stability testing prior to implementation. MVTR is one of many factors in assessing packaging system change including introducing new packaging configuration (e.g., HDPE bottle with a new count). These factors are, amongst others, the composition of the container–closure system, product requirements, and stability. However, MVTR may be useful in a product development setting, to decide on the packaging components before packaging exhibit batches, or in a pharmacy setting where product is being repackaged.

In addition, the USP Packaging and Distribution Expert Committee is proposing the following revisions to <671>, which are meant to update the current chapter. The key changes being proposed are:

• Add USP Desiccant, Small RS; USP Desiccant, Medium RS; and USP Desiccant, Large RS to aid stakeholders in the execution of the chapter,
• Add a new water-filled method as an alternative approach to the desiccant-filled method in the Moisture Vapor Transmission for Plastic Packaging Systems section,
• Introduce a new informational chapter <1671> (see above), that is meant to support the current chapter revision.

Additionally, minor editorial changes have been made to update the chapter to current USP style.

After your registration to Pharmacopeial Forum you will have access to the drafts of the two general chapters <671> and <1671>.