Pharmaceutical R&D

When scientists at the Merck Frosst center for Therapeutic Research have identified a new chemical entity for development, the Formulation and Process Development group is responsible for developing the most appropriate dosage form, be it a tablet, capsule, oral solution, suspension, intravenous solution, lyophilized product or cream. The choice of pharmaceutical form is based on a number of factors, including in vivo results and targets, the physical characteristics and stability of the material, the patient population, and company strategy and standards. For example, the team is currently developing a new sprinkle formulation, consisting of oral granules, for pediatric use. This non-conventional dosage form will optimize drug delivery and help young children take their medicine easily and reliably.

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As a first step, the Formulation and Process Development team carries out model formulation studies, to help select appropriate excipients and processes. Based on the results of the model formulation study, the scientists prepare more refined formulations, suitable for use in clinical trials. As the clinical trials progress, the researchers refine, optimize, and, finally, scale up laboratory-scale formulations and processes to commercial production scale. At each step, Formulation and Process Development works to ensure the quality of the experimental drug product and the reproducibility of the process.

At every stage of product development the Formulation and Process scientists work closely with many other departments within Merck Frosst and Merck & Co., Inc. worldwide.

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In addition to developing new formulations, the group is working on new techniques to support formulation development, such as using NIR to determine end-point in powder blending, and electric capacitance tomography to evaluate drying profiles in fluid-bed drying. The scientists are constantly trying to improve on current delivery systems, and are at the forefront of new drug delivery technologies, such as rapidly dissolving tablets, chewable tablets, devices for aerosol drug delivery, and needleless injections.