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28 Sep 2021

Key considerations to develop effective analytical methods for your drug project

A summary exploring Recipharm’s key considerations when it comes to developing effective analytical methods for drug projects.

The formulation development process for any new drug candidate is complex and challenging. In order for the project to be successful, it’s important to be confident that the formulation is performing as intended, is safe for patients to use and offers the stability to provide consistent performance throughout its advertised shelf life. This requires comprehensive testing and analysis.

However, no two drug formulations are alike – each one has its own unique features. This means that pharmaceutical companies need to devise dedicated analytical methods for each new project – all while ensuring they provide the accuracy required. Here are the top three considerations from Recipharm Analytical Solutions™ for developing effective analytical methods for a drug formulation development project.

  1. Define the quality target product profile (QTPP) at the very beginning

This needs to be done as early on in the project as possible to ensure the analytical methods are truly able to control the quality of the final product. Failure to do this will result in unnecessary delays, which extend development timelines. An ideal QTPP will include a list of quality attributes (QAs) that are required of the finished product to ensure optimum product performance and patient safety. These can then be used to develop effective and rapid analytical methods to test that the product meets these QAs.

  1. Remember to test both API and excipient together from the outset

All drug products are the combination of API and inactive excipients, and the performance and quality of the finished treatment will depend on how these ingredients work together. Appropriate compatibility studies must be performed on both API and excipient together in order to fully understand their performance. These studies should include: particle size distribution for drug substance; differential scanning calorimetry; thermogravimetric analysis; related substance profile; polymorphic form selection; and x-ray diffraction (XRD).

  1. Testing shouldn’t end at the formulation stage

The stability and shelf-life of the finished drug product have a key impact on its effectiveness, as well as patient safety, so it is also vital to carry out rigorous testing on any finished dosage form. The specificity of the testing method should be well established, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines should be used to ensure reporting, identification and quantification thresholds are met.

Expert support is vital

Analysis and testing play a vital role in any drug product development. Done well, they can not only ensure product quality and safety, but also minimise time-to-market and maximise the value of the product throughout its life cycle.  Developing effective testing methods requires an expert team who are experienced in devising testing solutions tailor-made to the specific needs of a project.

Outsourcing to companies like Recipharm Analytical Solutions™ can provide access to this expertise. Our expert team has experience from developing hundreds of analytical methods every year, supporting development of formulations ranging from powder in capsules and IV solutions to ER tablets and dry powder inhalers.

Working with such a partner, companies can be confident they have the tools and methods to fully understand their product, so they can continue to delivery high-quality and safe therapies to patients.

Mentioned Companies
Recipharm AB
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