Omeprazole formulation components
Pro Research Analysisby 
Searched over 200M research papers
Key Components in Omeprazole Formulations
Omeprazole formulations are designed to protect the drug from degradation in acidic environments and to ensure effective delivery and absorption. The main components and strategies used in these formulations are outlined below.
Active Ingredient and Core Materials
The core of most omeprazole formulations contains the active ingredient, which can be omeprazole itself, its alkaline salt, or a specific enantiomer of omeprazole. Sometimes, an alkaline-reacting compound is included in the core to further stabilize the drug against acid degradation 1236.
Excipients and Binding Agents
Pharmaceutically acceptable excipients are mixed with the active ingredient to aid in the manufacturing process and improve the stability and handling of the formulation. Common excipients include binding agents such as hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), which help maintain the integrity of the core 1236.
Enteric Coating and Separating Layers
To protect omeprazole from stomach acid, a separating layer and an enteric coating are applied over the core. The enteric coating prevents the drug from dissolving in the acidic environment of the stomach, allowing it to be released in the higher pH of the small intestine 1236. Materials like Eudragit® L100-55 are also used for pH-sensitive coatings in nanoparticle formulations .
Acid-Neutralizing Agents
Some formulations use acid-neutralizing agents such as sodium bicarbonate or magnesium oxide instead of, or in addition to, enteric coatings. These agents buffer the stomach acid, protecting omeprazole and enabling rapid release and absorption. Sodium bicarbonate is particularly effective in stabilizing omeprazole and ensuring quick drug release 457.
Liquid and Pediatric Formulations
For patients who cannot swallow tablets, such as children or the elderly, liquid suspensions are prepared. These often use sodium bicarbonate as a buffering agent, along with other excipients like glycerin, simple syrup, and preservatives to improve stability and palatability. The stability and organoleptic properties (taste, color, smell) of these formulations are carefully evaluated 578.
Nanoparticle suspensions are another approach for pediatric use, where omeprazole is encapsulated in polymeric nanoparticles with pH-sensitive coatings to enhance stability and therapeutic effect .
Specialized Delivery Systems
Innovative delivery systems, such as floating in situ gels, have been developed to prolong gastric residence time and sustain drug release. These systems use polymers and floating agents to form a gel in the stomach, minimizing omeprazole degradation and improving bioavailability .
Conclusion
Omeprazole formulations typically include the active drug, binding agents (like HPMC or HPC), acid-neutralizing compounds (such as sodium bicarbonate), and protective enteric coatings. For liquid and pediatric formulations, additional excipients are used to ensure stability and palatability. Advanced delivery systems, including nanoparticles and floating gels, further enhance omeprazole’s stability and absorption, meeting the needs of diverse patient populations 12345678+2 MORE.
Sources and full results
Most relevant research papers on this topic