Background/Objectives: Omeprazole undergoes degradation in acidic conditions, which makes it unstable in low pHs found in the gastric environment. The vast majority of already marketed omeprazole formulations use enteric polymer coatings to protect the drug from exposure to acidic pH in the stomach, allowing for drug release in the small intestine where the pH is higher. This study aimed to explore the technical aspects of using stomach acid neutralizers as an alternative to polymeric coatings for omeprazole. Methods: After evaluating various neutralizers, magnesium oxide and sodium bicarbonate were chosen to be incorporated into capsules containing omeprazole, which then underwent in vitro dissolution testing to assess their ability to maintain optimal pH levels and ensure appropriate dissolution kinetics. Hygroscopicity and chemical stability of the selected formulation were tested to prove pharmaceutical quality of the product. An in vivo pharmacokinetic study was conducted to demonstrate the efficacy of the omeprazole–sodium bicarbonate formulation in providing faster absorption in humans. Results: Sodium bicarbonate was selected as the most suitable antacid for ensuring omeprazole stabilization. Its quantity was optimized to effectively neutralize stomach acid, facilitating the rapid release and absorption of omeprazole. In vitro studies demonstrated the ability of the formulation to neutralize gastric acid within five minutes. In vivo studies indicated that maximum concentrations of omeprazole were achieved within half an hour. The product met the requirements of pharmaceutical quality. Conclusions: An easily manufacturable, fast-absorbing oral formulation was developed as an alternative to enteric-coated omeprazole.

Introduction: Elevated low-density lipoprotein cholesterol (LDL-C) is a causal, modifiable risk factor for atherosclerotic cardiovascular disease (ASCVD). In individuals at low-to-moderate cardiovascular risk who do not meet criteria for lipid-lowering pharmacotherapy, or who are not willing to use statins or are intolerant, non-pharmacological options are clinically relevant; however, efficacy must be demonstrated for the finished formulation rather than extrapolated from its individual ingredients. Material and methods: CHOLAMAZEN (ClinicalTrials.gov NCT07405814) is an international, randomized, double-blind, placebo-controlled, parallel-group trial conducted in Italy and Poland. A total of 106 adults aged 18-70 years with previously untreated mild-to-moderate hypercholesterolemia will be randomized 1:1, stratified by sex, to receive Artisterol or matching placebo once daily for 12 weeks. Each 10-ml liquid stick pack of Artisterol provides 1,200 mg plant sterols, 500 mg artichoke (Cynara scolymus) leaf extract, and 5 mg thiamine (vitamin B1). Results: The primary endpoint is the absolute mean change in LDL-C from baseline to Week 12. Secondary endpoints include changes in total cholesterol, HDL-C, non-HDL-C, triglycerides, apolipoprotein B, fasting plasma glucose and hepatic transaminases, together with adverse-event monitoring and compliance assessment. Exploratory analyses will evaluate LDL-C and secondary outcomes across baseline, Week 6 and Week 12. Conclusions: This protocol is designed to determine whether a non-monacolin, statin-free liquid formulation containing plant sterols, artichoke leaf extract and thiamine lowers LDL-C versus placebo and is safe and well tolerated over 12 weeks. Reporting follows Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2025, and trial results will be reported according to the registered endpoints.