Although industry guidelines, excipient monographs and compendial test methods provide some direction, the sourcing and testing of excipients is an ongoing challenge for drug manufacturers. In pharmaceutical manufacturing, the active pharmaceutical ingredient (API) needs to be formulated into a final dosage form that must fulfil a number of objectives and goals. The dose form must be a convenient method for administration while also ensuring accurate and consistent dosing; it must improve bioavailability and palatability through taste masking, provide a controlled and predictable method of drug dissolution and release, and reduce any side-effects of the medication.
The objective of a successful formulation project is to develop robust formulations that meet the appropriate performance requirements for drug bioequivalence and stability, and that are suitable for validated production at commercial scale. However, such formulations need to be developed in time to meet production and commercialisation deadlines.
A robust formulation is one that is able to accommodate the typical variability seen in API and excipient properties, such as chemical purity and physical characteristics — including particle size and particle shape — and to accommodate any variability in production processes without compromising the manufacture, stability, performance or any other attribute of the product. Any deviations from the parameters set in formulation development can have significant consequences to the patients’ care or well-being.
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