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Omeprazole was a subject of a patent litigation in the U.S. [66] The invention involved application of two different coatings to a drug in pill form to ensure that the omeprazole did not disintegrate before reaching its intended site of action in stomach. Although the solution by means of two coating was obvious, the patent was found valid ...
A derivative of timoprazole, omeprazole, was discovered in 1979, and was the first of a new class of drug that control acid secretion in the stomach, a proton pump inhibitor (PPI). [11] [12] Addition of 5-methoxy-substitution to the benzimidazole moiety of omeprazole was also made and gave the compound much more stability at neutral pH. [6]
The drugs and the enzymes they probe are as follows - caffeine (probes CYP1A2, N-acetyltransferase 2, xanthine oxidase), midazolam (probes CYP3A), omeprazole (probes CYP2C19) and dextromethorphan (probes CYP2D6). After giving the cocktail, the concentrations of the drugs and their metabolites in plasma (for midazolam and omeprazole) and urine ...
[20] [21] [22] In the United States, the Food and Drug Administration (FDA) has advised that over-the-counter PPIs, such as Prilosec OTC, should be used no more than three 14-day treatment courses over one year. [23] [24] Despite their extensive use, the quality of the evidence supporting their use in some of these conditions is variable.
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
Cimetidine was the prototypical histamine H 2 receptor antagonist from which later drugs were developed. Cimetidine was the culmination of a project at Smith, Kline & French (SK&F; now GlaxoSmithKline) by James W. Black, C. Robin Ganellin, and others to develop a histamine receptor antagonist that would suppress stomach acid secretion.
An enteric coating is a polymer barrier applied to oral medication that prevents its dissolution or disintegration in the gastric environment. [1] This helps by either protecting drugs from the acidity of the stomach, the stomach from the detrimental effects of the drug, or to release the drug after the stomach (usually in the upper tract of the intestine). [2]
Drug Information Portal. U.S. National Library of Medicine. U.S. National Library of Medicine. Clinical trial number NCT03198507 for "ERADICATE Hp2 - Treating Helicobacter Pylori With RHB-105 Compared to Active Comparator (ERADICATE Hp2)" at ClinicalTrials.gov