Pharmaceutical R&D

Discovering an exciting new chemical entity may seem the most dramatic chapter, but it is only the beginning of the drug development story. The Pharmaceutical Research and Development department at Merck Frosst has the task of turning the concept into reality, designing an appropriate dosage form to get the medicine from the bench to the patient.

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This supremely challenging reduction to practice involves the combined skills of more than 60 scientists and support staff with expertise in pharmaceutics, polymer chemistry, physical chemistry, analytical and bio-analytical chemistry and pharmacokinetics.

The research teams must decide whether the potential drug is presented to patients as capsules, tablets, an injectable, cream, ointment or aerosol. The major area of expertise at the Research Centre is in solid oral dosage forms and it is also the main group within Merck worldwide that has aerosol formulation knowledge and experience.

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The development of a new formulation by scientists in Pharmaceutical Research and Development requires thorough physico-chemical and mechanical characterization of the new compounds, development of analytical and bio-analytical methods and evaluation of initial probe formulations. These activities lead to the development of stable and bioavailable formulations that allow the testing of the potential new medicines in humans in large clinical centres around the world.

Consignments of experimental formulations of the potential drug are shipped to the clinical trial centres directly from our new, state-of-the-art Clinical Supplies centre that was constructed in 1992. It represents a major expansion in our ability to support the global clinical studies of Merck & Co., Inc. This is the area where processes used to make the dosage form are optimized and scaled-up.

Before a new medicine is successfully introduced to patients and becomes available worldwide, the Pharmaceutical Research and Development team at Merck Frosst must accomplish the technology transfer to the Merck Manufacturing Division to ensure a robust, efficient manufacturing process, watertight quality control and ultimately, a happy ending to another great story, well told.