Omeprazole suspension brand name
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Omeprazole Suspension Brand Name: Acitrel and Rapinex
Introduction to Omeprazole Suspension
Omeprazole is a widely used medication for treating various gastrointestinal conditions such as dyspepsia, peptic ulcer disease, gastroesophageal reflux disease (GERD), laryngopharyngeal reflux, and Zollinger-Ellison syndrome. It is commonly available in tablet and capsule forms under brand names like Prilosec and Losec, as well as from various generic manufacturers.
Development of Omeprazole Suspension
Immediate-Release Formulation
Santarus Inc. has developed an immediate-release formulation of omeprazole combined with an antacid (sodium bicarbonate) as a powder for suspension. This formulation is known as Acitrel (SAN 05) and also as Rapinex powder for oral suspension . The development of this suspension is based on technology licensed from the University of Missouri, with additional licenses from Tulane and North Carolina Universities for potential treatments of gastrointestinal diseases .
Licensing and Marketing
Santarus has secured exclusive, worldwide rights to patent applications covering specific combination formulations of proton pump inhibitors (PPIs) and antacids for treating various upper gastrointestinal diseases and disorders. The company plans to license the development, distribution, and marketing rights of the omeprazole powder for oral suspension (20 mg) outside the US to well-established pharmaceutical companies .
FDA and Naming Considerations
The US FDA has requested that Santarus pursue a name other than Rapinex for the product. As a result, Santarus is currently in discussions with the FDA to determine an alternative name for the product .
Clinical Trials and Safety
Phase III Trials
In August 2003, Santarus announced positive results from a phase III trial comparing oral Acitrel (Rapinex 40 mg) with intravenous cimetidine in preventing upper gastrointestinal bleeding in 359 critically ill adult patients .
Open-Label Clinical Trials
Santarus also completed an open-label clinical trial involving 243 patients, including 97 patients with gastric ulcers, to evaluate the safety of the omeprazole 40 mg powder suspension over an 8-week period .
Stability and Compounding
Stability in SyrSpend SF Alka
A study examined the stability of omeprazole in SyrSpend SF Alka (reconstituted), a vehicle for making a suspension with a pleasant taste, thus increasing palatability and compliance. The study found that the shelf life of the product is at least 92 days when refrigerated and protected from light.
Compounding from Solid Dosage Forms
In New Zealand, where no liquid formulations of omeprazole are commercially available, suspensions must be extemporaneously compounded from solid dosage forms. A study identified that suspensions prepared from Losec and Dr. Reddy's brands of omeprazole 20 mg capsules demonstrated acceptable quality and stability for 20 days when stored at 4°C and protected from light.
Conclusion
The development of omeprazole suspension by Santarus Inc., known as Acitrel and Rapinex, represents a significant advancement in the treatment of gastrointestinal conditions, particularly for patients who cannot take tablets or capsules. With ongoing discussions with the FDA regarding the product name and positive clinical trial results, this formulation is poised to offer a valuable alternative in the management of upper gastrointestinal diseases.
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