Formulation is the Cinderella of Drug Development

Without an effective, stable formulation, an API is essentially worthless.

Formulation has become one of the most overlooked parts of drug development, but it can be the difference between an effective medicinal product and a very expensive placebo.

A successful robust medicinal product is the result of a controlled set of interactions between the API, excipients and process. A given molecule, on its own, has a certain potential, but without a proper formulation it could simply be a poison. (All drugs are poisons! The difference between a drug and a poison is a balance of dose and route of administration.)

Many drug development projects fail because of poor understanding of factors that influence drug absorption, others because of poor understanding of the factors that influence drug stability. Contrary to popular belief, formulation and process design are not driven by the therapeutic category of the drug candidate, but are in part driven by the physical and chemical properties of the active pharmaceutical ingredient (API), and the route of administration.

The same type of formulation approach may be used for an antihypertensive, antibiotic or a neurological agent if the route of administration and physicochemical properties of the API are similar.

There are few APIs, novel or existing, that cannot be successfully formulated to provide adequate dosing in man or animals.

FinnBrit Consulting has the knowledge and experience necessary to provide advice on all aspects of formulation and drug development.

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