The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs.
The British Pharmacopoeia first launched the consultation
in January 2017 to gather input from stakeholders on ways the pharmacopoeia could improve its approach to dissolution testing in its finished product monographs.
Dissolution testing is performed for solid oral drugs to determine the rate at which the active pharmaceutical ingredient is released. Data from dissolution testing is also used for quality control purposes to show consistency across batches.
“A pharmacopoeial dissolution test is a crucial analytical procedure which needs to be robust and reproducible. Ideally, the test will identify critical changes to the performance of a product and be able to discriminate between differences in batch quality of multiple formulations,” the British Pharmacopoeia writes.
Industry stakeholders commented that they would like to see the British Pharmacopoeia adopt “Q” acceptance criteria, which describes the quantity of the active ingredient that is dissolved in a set amount of time in terms, across both new and existing monographs.
According to the British Pharmacopoeia, there are more than 400 monographs from before 2008 that do not use the Q criteria approach.
“This causes confusion for users and emerged as a key theme for all the responses received,” the British Pharmacopoeia writes, adding that it will review the monographs that do not contain a dissolution test and update them to include one with suitable Q acceptance criteria.
The British Pharmacopoeia also said it plans to add information on alternative methods for dissolution testing where necessary. “The responses indicated that there could be instances where alternative methods may be required; the [British Pharmacopoeia] will seek to provide sufficient guidance on the justification of alternative methods,” the British Pharmacopoeia writes.
However, the British Pharmacopoeia noted that respondents generally felt that its dissolution testing methods “are still relevant and should be retained” and kept harmonized with those described by the Pharmacopoeial Discussion Group, which includes the European Pharmacopoeia, the US Pharmacopeia and the Japanese Pharmacopoeia.
The consultation also revealed that many users found the British Pharmacopoeia’s supplementary chapter on dissolution testing (SC I E:Dissolution Testing of Solid Oral Dosage Forms) to be difficult to navigate. The British Pharmacopoeia says it will revise the chapter to make it easier to follow in time for its 2020 edition.
, Consultation Response