Santarus, Inc., a specialty pharmaceutical company, has announced that it is developing a new new tablet formulation to add to its Zegerid family of branded prescription pharmaceutical products.
The new formulation is a swallowable tablet that combines immediate-release omeprazole, a proton pump inhibitor (PPI), with a mix of buffers. Santarus plans to undertake clinical and stability studies with the tablet in preparation for the submission of an NDA to the US Food and Drug Administration. The company's objective is to have the new Zegerid tablet product commercially available in the US 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 T. Proehl, president and chief executive officer of Santarus. "Our progress in developing a Zegerid tablet formulation reflects our past experience in developing other immediate-release PPI products. We have a successful track record of moving quickly through product and clinical development to regulatory approval for Zegerid capsules and powder for oral suspension. We are focused on achieving similar results for this new Zegerid formulation so we can expand the Zegerid family of product offerings".
Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), maintenance of healing and short-term treatment of erosive esophagitis, and short-term treatment of active benign gastric ulcers and active duodenal ulcers. Zegerid powder for oral suspension 40 mg is also indicated for the reduction of risk of upper gastrointestinal bleeding in critically ill patients.
PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs in the US, other than Zegerid, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression.