Omeprazole formulation ingredients
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Core Ingredients in Omeprazole Formulations
Omeprazole formulations typically contain the active ingredient omeprazole or its alkaline salts, such as omeprazole magnesium. The core of the formulation may also include an alkaline-reacting compound to help stabilize the drug in the acidic environment of the stomach. This core is often mixed with pharmaceutically acceptable excipients, such as binding agents, to aid in the manufacturing process and ensure proper tablet or pellet formation 1237.
Excipients and Binding Agents in Omeprazole Tablets and Pellets
Pharmaceutically acceptable excipients are essential for the stability and manufacturability of omeprazole formulations. Common excipients include binding agents like hydroxypropyl methylcellulose (HPMC) or hydroxypropyl cellulose (HPC), which help hold the formulation together and can influence the drug’s release profile. Other excipients may include surfactants, inert core materials, and alkali agents to further protect the active ingredient 12357.
Enteric Coating and Separating Layers
To protect omeprazole from degradation in the acidic stomach environment, most oral formulations use an enteric coating. This coating is applied over a separating layer that sits on top of the core material. The enteric coating ensures that the drug is only released in the higher pH environment of the small intestine, where it is more stable and can be absorbed effectively 12357.
Alternative Formulation Approaches: Acid-Neutralizing Agents
Some newer formulations use acid-neutralizing agents, such as sodium bicarbonate or magnesium oxide, instead of or in addition to enteric coatings. These agents rapidly neutralize stomach acid, protecting omeprazole and allowing for faster drug release and absorption. Sodium bicarbonate, in particular, has been shown to be effective in stabilizing omeprazole and enabling rapid absorption, making it suitable for immediate-release formulations 4610.
Liquid Omeprazole Formulations
For patients who cannot swallow tablets, such as pediatric or geriatric patients, liquid omeprazole formulations are prepared. These often use sodium bicarbonate as a buffering agent to maintain a stable pH and improve omeprazole stability in suspension. Other excipients in liquid formulations may include simple syrup, glycerin, and purified water. The choice of excipients can affect the stability, taste, and appearance of the final product 610.
Stability and Compatibility of Excipients
Studies show that omeprazole magnesium is compatible with a range of excipients, with no significant drug-excipient interactions affecting drug concentration over time. However, some excipients, like aerosil 200, may cause color changes under certain conditions. The overall formulation must comply with pharmacopeial standards for flowability, compressibility, and stability 89.
Conclusion
Omeprazole formulations are complex and carefully designed to protect the active ingredient from stomach acid, ensure stability, and provide effective drug release. Key ingredients include omeprazole or its salts, alkaline-reacting compounds, binding agents like HPMC or HPC, and enteric coatings. Alternative approaches use acid-neutralizing agents such as sodium bicarbonate for rapid-release formulations. The choice and combination of excipients are critical for the stability, manufacturability, and patient acceptability of both solid and liquid omeprazole products 12345678+2 MORE.
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