Excipients Formulation Development Support
Excipients in Formulation Development
Excipients play a central role in the drug development process, in the formulation of stable dosage forms and in their administration. The intended function of an excipient is to act as the vehicle or as a component of the carrier of the active substance. Excipients contribute to product characteristics such as biopharmaceutical profile, stability, assist in product identification, appearance and patient acceptance and aid the processing of the drug delivery system during its manufacture. Excipients can protect the pharmaceutical dosage form from oxidation by acting as antioxidants or modify the taste of a medicine and contribute to improving patient compliance.
Though excipients were at one time assumed to be “inactive” ingredients, it is now understood that excipients can have an important impact on the pharmaceutical and chemical performance of a drug product formulation.
The functionality of an excipient can depend on complex interactions between the components of the formulation and on stresses associated with the manufacturing process and is determined by its physicochemical properties, molecular structure and content of by-product or additives.
It’s therefore important to identify unknown and control Functionality Related Characteristics (FRC) of excipient materials, to manage their effects on pharmacodynamics and pharmacokinetics and achieve safe, robust and stable pharmaceutical products.
Our extensive experience in excipient formulation development and excipient characterization allow us to explain observed excipient formulation characteristics or to pin-point product specific Functionality Related Characteristics (FRC).
Combined Analytical, Pharmaceutical and Dissolution lab Services
Excipia can help companies with their formulation development
- to identify critical (combinations of) excipients and Functionality Related Characteristics (FRCs) in formulations,
- investigate formulation and excipient batch-to-batch variability,
- troubleshoot underperforming pharmaceutical formulations,
- select specific excipient batches, grades, or suppliers,
- set in-house excipient specifications for customized pharmaceutical product properties.
n addition, due to the unique combination with a pharmaceutical development and dissolution testing services within Avivia, Excipia can provide comprehensive insight into various product features, such as detailed release performance, and apply and test new insights with small-scale development batches.