Various dosage forms contain different types of excipients. These pharmaceutical excipients are incorporated to support the manufacturing process, to protect, support, or enhance stability, improve bioavailability, or ensure patient compliance.
Active ingredients often possess reactive functional groups that are prone to interact with the functional groups of excipients. These interactions can lead to the formation of impurities in the finished dosage form.
Compatibility studies are designed to identify critical drug–excipient incompatibilities, their causes, and effects. The design of compatibility studies may involve:
- Utilizing mixtures of the drug with one or more excipients, with the addition of water to accelerate drug–excipient interactions. Hydrogen peroxide may also be introduced to induce oxidative stress.
- Incubating at various elevated temperatures and analyzing for physical and chemical changes in the drug at predetermined time intervals.
- Analyzing binary mixtures of drug and excipients using thermal methods such as Differential Scanning Calorimetry (DSC).
Examples of known incompatibilities include the interaction between lactose and amine-containing Active Pharmaceutical Ingredients (APIs), which can result in the Maillard reaction.
Please do not hesitate to contact us for more information on how you could investigate drug-excipient compatibility in the early stages of your development.
