Tuesday, 12 March 2024 9 .00 - 16.45 h
A "Stimuli to the Revision Process" article has been published in the Pharmacopoeial Forum 40(2) to propose a new method for measuring moisture vapour permeation.
The article is based on a workshop organised by the USP together with the Product Quality Research Institute (PQRI) last year.
It addresses a new method for the measurement of "moisture vapour transmission rate" (MVTR) for solid oral dosage forms like tablets or capsules usually packaged and stored in plastic bottles or blister packs.
The new method of measuring MVTR has been elaborated by the PQRI Container-Closure Working Group because the current method isn't sufficiently robust and leads to inconsistent results. The goal of the PQRI Working Group was to optimise this method in order to satisfy FDA expectations for supporting packaging systems in lieu of performing stability tests.
Both methods are gravimetric methods but the new procedure is more reliable and reproducible. Moreover it takes into account high-barrier and low-barrier materials.
The new method also aligns with the new ASTM International standard (D7009), which is an adaptation of the PQRI method.