Omeprazole sodium bicarbonate compound
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Omeprazole Sodium Bicarbonate Compound: Efficacy, Stability, and Clinical Applications
Introduction to Omeprazole Sodium Bicarbonate Compound
Omeprazole, a proton pump inhibitor (PPI), is commonly used to treat acid-related disorders such as gastritis, gastroesophageal reflux disease (GERD), and peptic ulcers. When combined with sodium bicarbonate, it forms an immediate-release formulation that enhances its efficacy and stability. This article synthesizes research findings on the bioequivalence, acid inhibitory effects, stability, and clinical applications of the omeprazole-sodium bicarbonate compound.
Bioequivalence and Acid Inhibitory Effects
Bioequivalence Studies
A study conducted in Mexico evaluated the bioequivalence of two oral-capsule formulations of omeprazole 20 mg combined with 1100 mg of sodium bicarbonate. This formulation is indicated for adults over 18 years for treating gastritis, reflux, and heartburn caused by excessive acid production . Another study compared the acid inhibitory effects of an immediate-release formulation of omeprazole 40 mg and sodium bicarbonate 1100 mg (CDFR0209) with delayed-release omeprazole 40 mg (omeprazole-DR). The results showed that both formulations were equally effective in decreasing integrated gastric acidity at steady state .
Comparative Efficacy with Other PPIs
In a randomized crossover study, the onset of action and efficacy of immediate-release omeprazole 20 mg/sodium bicarbonate 1100 mg (IR-OME) were compared with delayed-release lansoprazole 15 mg. The study found that IR-OME achieved a faster onset of action and better gastric acid suppression at steady state compared to DR-lansoprazole . Additionally, a systematic review indicated that while omeprazole/sodium bicarbonate therapy is not more effective than omeprazole alone, it tends to provide a more sustained response and quicker relief 79.
Stability of Omeprazole-Sodium Bicarbonate Formulations
Stability in Various Conditions
Research on the stability of omeprazole-sodium bicarbonate oral suspensions has shown that these formulations remain stable under various conditions. A study found that omeprazole-sodium bicarbonate suspension 2 mg/mL prepared from 20 mg packets was stable for at least 45 days when stored at 3-5°C . Another study demonstrated that omeprazole 2 mg/mL in an oral liquid compounded from capsules and sodium bicarbonate injection was stable for up to 30 days at 5°C and -20°C, but only for 14 days at 24°C . Furthermore, flavored omeprazole-sodium bicarbonate suspensions retained over 96% of their initial concentration when refrigerated for one month .
Administration Through Feeding Tubes
The feasibility of administering omeprazole-sodium bicarbonate suspension through neonatal and pediatric nasogastric feeding tubes was also evaluated. The suspension was easily administered through various sizes of feeding tubes, unlike lansoprazole bead mixtures, which tended to clog smaller tubes .
Clinical Applications and Comparative Studies
Treatment of Helicobacter pylori Infection
A study comparing the efficacy of omeprazole-amoxicillin combination therapy with ranitidine/sodium bicarbonate-amoxicillin for treating Helicobacter pylori infection found that neither therapy was particularly effective, with cure rates of 46% and 39%, respectively .
Gastroesophageal Reflux Disease (GERD)
Omeprazole-sodium bicarbonate has been extensively studied for its efficacy in treating GERD. A systematic review concluded that while it is not more effective than omeprazole alone, it offers a more sustained response and quicker relief in some patients 79.
Conclusion
The combination of omeprazole and sodium bicarbonate offers several advantages, including faster onset of action, sustained acid suppression, and stability under various storage conditions. While it may not be significantly more effective than omeprazole alone for all conditions, it provides a valuable alternative for patients requiring immediate relief and sustained acid control. Further research and clinical trials could help optimize its use in treating acid-related disorders.
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