San Diego, USA-based Santarus, a specialty drug company, says that it is developing a new tablet formulation to add to its Zegerid family of branded prescription pharmaceutical products. The new formulation is a tablet that combines immediate-release omeprazole, a proton pump inhibitor, with a mix of buffers. Santarus plans to undertake clinical and stability studies with the tablet in preparation for the submission of a New Drug Application to the Food and Drug Administration. The company's objective is to have the new Zegerid tablet product commercially available in the USA in the second half of 2009.
"Our goal was to design an optimized tablet formulation that has the potential to provide features and benefits that are important to physicians and their patients. We have evaluated the new formulation in a pilot clinical study with positive results," said Gerald Proehl, chief executive of Santarus. "Our progress in developing a Zegerid tablet formulation reflects our past experience in developing other immediate-release PPI products."
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