10/11 March 2021
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
The scope of this chapter is restricted to
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:
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>.