Quality of Design in Formulation Development

The FDA and EMEA are now actively seeking applications using the concepts of Quality by Design (QbD).  Here the quality of the product is built in by virtue of appropriate testing and design space analysis. When building a formulation by QbD it is important to start with the properties of the API and make the correct selection of form for the intended use.  Then there must be an understanding of interactions with excipients and the formulation process.  All are understood to define a region of variability that will be possible to achieve a successful medicinal product.

Building quality – from API to medicinal product

The first stage in Quality by Design is the selection of the best form to develop. This is a science based understanding of the factors that will be important for the API. The decisions will vary depending on many factors such as intended route of delivery, the inherent issues with the API (solubility and stability for example) and proposed product types.  Pharmaterials have many years of experience and are skilled in the application of QbD concepts to the design of experiments and interpretation of data.  This sets you on the right path with the correct physical form that is optimised for your selected delivery route and method.

We will:

• investigate the solid forms that exist and advise on their suitability for the intended uses
• give advice and help to allow the selection of the optimum solid form
• give advice of the need for controls, and then provide specifications for control of key attributes including particle size distribution, flow properties etc.
• use our knowledge, skills and outstanding instrumentation to ensure that we understand how the form may change in the process of manufacturing a pharmaceutical medicinal product.  This understanding linked with the best selection of form to minimise risk of change is important to show the design space that allows confidence that there will be no changes in the product and allows specifications to be set for the API in the product.
• use our state-of-the-art rapid excipient compatibility testing to speed the quality development process and back this up with chromatographic analysis
• select excipients for formulation development on an understanding of compatibility, functionality and suitability to meet the desired challenges.
• screen for the best formulation approaches as required, potentially using our high throughput formulation screening, or use the customer selected formulation approach and optimise the form and processing selection to ensure robustness.
• utilise design of experiments to meet customer needs as and when required.

Pharmaterials are delighted to provide a full QbD service in screening and formulation / analytical development to ensure your product is best placed for success.