British Pharmacopoeia consultation response on dissolution testing published

In January 2017 the British Pharmacopoeia (BP) invited key stakeholders to provide feedback and advice on how the BP could update dissolution testing in the pharmacopoeia. The consultation closed in April 2017 and a review by the Expert Advisory Group for Pharmacy followed in September 2017. The results and conclusions have now been published as part of a planned series of important stakeholder engagement activities that the BP will undertake in 2019.

Based on the discussions and recommendations from the consultation the BP Secretariat, with the support of the BP Commission, aims to develop a revised policy on dissolution testing. The BP has addressed each of the points raised with a clear action plan that defines how this policy will be implemented.

The key points are:

  • current dissolution testing methods in the BP are still relevant and should be retained 
  • dissolution requirements within monographs should all be expressed in terms of active substance dissolved in a specified time (also known as the internationally harmonised quantity Q). The BP will revise applicable monographs to include this acceptance criteria and revisions will be prioritised based on the use and impact of the product
  • control of prolonged-release solid oral dosage forms, such as tablets and capsules, poses different and more complex challenges and the BP will continue to seek appropriate and robust standards for dissolution testing of these products 
  • the relationships between the BP and its stakeholders are vital to ensuring the quality of medicines. The BP will update the guidance for dissolution testing, and ensure these changes are clearly visible to all users.

James Pound, Secretary & Scientific Director for the British Pharmacopoeia Commission and Group Manager for the British Pharmacopoeia & Laboratory Services, MHRA said:

“Dissolution testing remains a critical quality attribute for pharmacopoeial monographs and plays a crucial role in demonstrating the quality of a finished products, such as tablets and capsules.

“This BP consultation focusses on how best we can work with stakeholders to ensure that monographs provide a dissolution test that is useful in determining the quality of a product.

“The BP values the input from its stakeholders and will continue to engage with trade groups, industry and members of the Expert Advisory Groups, to ensure that focus of the work remains on protecting public health.”

Read more about the consultation response or find out more about the original consultation.