Omeprazole delayed release 40 mg
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Omeprazole Delayed Release 40 mg: Efficacy and Pharmacokinetics
Introduction to Omeprazole Delayed Release 40 mg
Omeprazole is a widely used proton pump inhibitor (PPI) that effectively treats various acid-related gastrointestinal disorders, including gastroesophageal reflux disease (GERD) and peptic ulcers. The delayed-release formulation of omeprazole is designed to protect the drug from the acidic environment of the stomach, ensuring its release in the more neutral pH of the intestines.
Comparative Efficacy of Omeprazole Formulations
Omeprazole Delayed Release vs. Immediate Release
Studies have shown that both immediate-release and delayed-release formulations of omeprazole are effective in reducing gastric acidity. A study comparing the acid inhibitory effects of a combination of immediate-release omeprazole and sodium bicarbonate (CDFR0209) with delayed-release omeprazole (Losec 40 mg) found that both formulations were equally effective in decreasing integrated gastric acidity at steady state1. Another study demonstrated that immediate-release omeprazole provided significantly better control of 24-hour intragastric acidity compared to delayed-release lansoprazole and pantoprazole when dosed in the morning3.
Pharmacokinetics Under Different Conditions
The pharmacokinetic profile of omeprazole can vary depending on whether it is taken in a fasting or fed state. A study comparing the pharmacokinetics of immediate-release and delayed-release omeprazole under fasting and fed conditions found that the immediate-release formulation had a higher maximum plasma concentration (Cmax) and a lower time to reach maximum concentration (Tmax) compared to the delayed-release formulation4. The presence of food reduced the rate and extent of systemic exposure for both formulations4.
Bioequivalence and Safety
A study conducted on healthy Filipino subjects evaluated the bioequivalence of a new 40 mg delayed-release capsule formulation of omeprazole relative to the reference marketed Losec® capsule. The results indicated that the new formulation was bioequivalent to the reference product, with both formulations being well tolerated and no significant adverse events reported5.
Pediatric Use and Efficacy
Omeprazole is also used in pediatric patients for the treatment of erosive esophagitis and GERD. A review of studies on the efficacy of delayed-release oral suspension of omeprazole in children reported a median symptom relief rate of 80.4%, with significant reductions in esophageal reflux index and intragastric acidity. Endoscopic healing rates were 84% after 8 weeks and 95% after 12 weeks of treatment8.
Conclusion
Omeprazole delayed-release 40 mg is an effective and well-tolerated treatment for acid-related gastrointestinal disorders. It offers comparable efficacy to immediate-release formulations in reducing gastric acidity and has been shown to be bioequivalent to established marketed products. Its use in pediatric patients also demonstrates significant efficacy in treating esophagitis and GERD. The choice between immediate-release and delayed-release formulations may depend on specific patient needs and conditions, including the timing of dosing and the presence of food.
Sources and full results
Most relevant research papers on this topic
Acid Inhibitory Effect of a Combination of Omeprazole and Sodium Bicarbonate (CDFR0209) Compared With Delayed‐Release Omeprazole 40 mg Alone in Healthy Adult Male Subjects
CDFR0209 and delayed-release omeprazole 40 mg are equally effective in decreasing integrated gastric acidity in healthy adult male subjects.
RCT
Very Rigorous JournalIntragastric acidity and omeprazole exposure during dosing with either PA32540 (enteric‐coated aspirin 325 mg + immediate‐release omeprazole 40 mg) or enteric‐coated aspirin 325 mg + enteric‐coated omeprazole 40 mg – a randomised, phase 1, crossover study
PA32540 effectively reduces upper gastrointestinal side effects while maintaining omeprazole exposure, compared to enteric-coated aspirin 325 mg + enteric-coated omeprazole 40 mg.
RCTControl of 24-hour Intragastric Acidity With Morning Dosing of Immediate-release and Delayed-release Proton Pump Inhibitors in Patients With GERD
Immediate-release omeprazole provides significantly better control of 24-hour intragastric acidity than delayed-release lansoprazole and pantoprazole when dosed in the morning.
RCTPharmacokinetics of a New Immediate-release Compound Omeprazole Capsule and its Comparison with the Enteric-coated Formulation under Fasting and Fed Conditions
Compound omeprazole capsule has rapid but similar absorption to delayed-release omeprazole under both fasting and fed conditions.
RCTBioequivalence of Omeprazole Delayed-Release Capsules in HealthyFilipino Subjects
The new omeprazole 40 mg delayed-release capsule and the established marketed Losec® capsule (2x20 mg) are bioequivalent and well-tolerated in healthy adult Filipino subjects.
Development and validation of UV Spectrophotometric method for simultaneous equation of Aspirin and Omeprazole in tablet dosage form
The UV spectrophotometer method is a simple, cost-effective, and robust method for simultaneous estimation of Aspirin and Omeprazole in tablet dosage forms, with minimal %RSD.
Omeprazole/Antacid-powder suspension-Santarus: omeprazole/sodium bicarbonate powder-Santarus, SAN 05.
Santarus Inc. is developing an immediate-release omeprazole powder suspension (Acitrel) to treat gastrointestinal diseases, including gastrointestinal haemorrhage, gastro-oesophageal reflux disease, heartburn, and peptic ulcers.
Delayed-release oral suspension of omeprazole for the treatment of erosive esophagitis and gastroesophageal reflux disease in pediatric patients: a review
Omeprazole at a dose of 0.3 to 3.5 mg/kg once daily for at least 12 weeks is highly effective in treating childhood esophagitis, providing symptom relief, reduced reflux index, and improved endoscopic healing rates.
Systematic Review
Rigorous JournalOmeprazole-induced slowing of gastrointestinal transit in mice can be countered with tegaserod.
Omeprazole slows gastrointestinal transit in mice, but this effect can be reversed by tegaserod, making it a potential treatment for dyspeptic symptoms.
Non-RCT
Animal Study