Advancing pharmaceutical and biopharmaceutical formulations in drug development

Drug products contain an active pharmaceutical ingredient (API) and other inactive ingredients, such as excipients, diluents, lubricants, and binders. The purpose of the inactive ingredients is to optimise the drug’s performance, for example by modifying drug release or facilitating absorption. The API together with these ingredients make up the drug formulation. 

During drug development, all drug products are formulated to particular dosage forms – such as oral tablets, capsules, injections, topical and inhaled – in order to be delivered effectively to the patient. Formulation development therefore depends on the dosage form, as will the technology required and the challenges facing research and development (R&D) scientists.

The process of formulation development ensures that the drug being manufactured is chemically and physically stable, and remains so throughout its shelf life. Formulations must also be bioavailable, and meet regulatory requirements and quality standards to ensure patient safety.

APIs must be physically and chemically compatible with the excipient within a given formulation. Selecting the right excipient is usually the first stage of formulation development and recent technological advances have provided a clearer picture of the interactions of excipients with APIs.

Infrared spectroscopy is a powerful analytical technique for formulation development and optimisation during drug development. Fourier Transfer Infrared (FT-IR) spectroscopy elucidates the influence of the formulation on protein stability in biopharmaceutical drug products.

Dynamic nuclear polarisation (DNP) enhances the spectroscopic sensitivity and signal intensity of nuclear magnetic resonance (NMR), and has become a newly developing field in the characterisation of pharmaceutical compounds. DNP-NMR spectrometers can help researchers and drug developers in the rapid determination of drug formulation components, therefore speeding up the drug development process whilst maintaining safety and efficacy.