Formulation and Process Design

The objective of the formulation project is to design and manufacture medicines that deliver the drug to the patient: in the required amount (content and assay), at the optimum rate necessary to achieve the desired therapeutic benefit (in vivo dissolution and absorption), consistently: within lots (blend uniformity for all components), between lots (validated manufacturing process), and for the shelf life of the product (stability). At the same time, the development process has to be efficient.

The formulation scientist, in designing a new formulation, brings together four sets of information:

- Knowledge and understanding of the excipients, their characteristics and limitations, and how these relate to different types of product and processing.

- Knowledge and understanding of the different types of unit processes used in pharmaceutical manufacturing, their limitations, and the constraints imposed upon materials and the formulation by these processes.

- Knowledge and understanding of how to interpret the results of the preformulation screening on the bulk active pharmaceutical ingredient (API) with respect to the requirements of the patient, the route of administration and the type of dosage form and how it is made.

- Knowledge and understanding of how all these different components interact to produce a robust, stable product which delivers the drug to the patient in the required amount, at the required rate, consistently within a lot and between lots, and over the shelf-life of the product.

There may be many different options for a formulation project. It is imperative that the correct options are selected.

FinnBrit Consulting has the experience in formulation and process design to advise on the best options for a particular project.

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