A number of guidances are available from different regulatory agencies, in particular the US FDA, to facilitate and expedite drug products development and evaluations. These guidances are related to dissolution method developments, apparatus calibration and product evaluations. In many cases, these guidances and related practices are commonly referred to by their acronyms, such as BCS, IVIVC, SUPAC, bio-waivers, similarity factor (F2) QbD, PVT, mechanical calibration. Examples of such commonly referred guidance documents are listed under the publications section.
It is important to note that these guidances solely or significantly depend on the use of dissolution (Paddle and Basket) apparatuses. Therefore, success or applications of these guidances are dependent on the outcome from these apparatuses.
In recent years, it has generally been recognised that Paddle and Basket apparatuses do not provide relevant and reproducible dissolution results. This is because of the poor hydrodynamics (or lack of efficient stirring and mixing) within dissolution vessels. Therefore, intended benefits from the use of the guidance documents may also become suspect.
Appropriate use and interpretation of the guidance documents require relevant and reproducible results. This may be achieved by conducting dissolution tests using apparatuses which are free from the deficiencies of Paddle and Basket, that is apparatuses with improved and efficient stirring and mixing environments.
