Intragastric 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

2013 ◽  
Vol 38 (1) ◽  
pp. 62-71 ◽  
Author(s):  
P. B. Miner ◽  
J. G. Fort ◽  
Y. Zhang
Keyword(s):  
Crossover Study ◽  
Phase 1 ◽  
Immediate Release ◽  
Intragastric Acidity ◽  
Enteric Coated Aspirin ◽  
Enteric Coated

Comparative Bioavailability of Enteric-Coated Aspirin Preparations

1980 ◽  
Vol 14 (2) ◽  
pp. 103-107 ◽  
Author(s):  
William J. Bicket ◽  
Susan M. Maynard ◽  
William T. Sawyer
Keyword(s):  
Salicylic Acid ◽  
Crossover Study ◽  
Drug Administration ◽  
Acid Content ◽  
Healthy Subjects ◽  
Enteric Coated Aspirin ◽  
Comparative Bioavailability ◽  
Enteric Coated

A three-way crossover study was conducted in nine healthy subjects to compare the bioavailability of one uncoated and two enteric-coated aspirin products after the administration of a single 650-mg dose of each preparation. Urine was collected at various intervals for 24 hours after drug administration and assayed for total salicylic acid content as an indicator of bioavailability. There were statistically significant differences among the three products in the amount of salicylic acid appearing in the urine, both for specific collection intervals and for cumulative (24-hour) excretions. Greater (p < 0.001) amounts of urinary salicylic acid were found in the first three hours after uncoated aspirin treatment than after enteric-coated aspirin administration. After 24 hours, equivalent amounts of salicylic acid were found following treatment with uncoated aspirin and one of the enteric-coated preparations. The absorption of aspirin from enteric-coated preparations is markedly delayed when compared to that from an uncoated product.

scholarly journals Yosprala: Coordinated Delivery of a Proton Pump Inhibitor and Aspirin

2019 ◽  
Vol 36 (2) ◽  
pp. 78-83
Author(s):  
Courtney A. Ingram ◽  
Gracie Giang ◽  
Katie McCrory ◽  
Terri M. Wensel
Keyword(s):  
Clinical Trials ◽  
Secondary Prevention ◽  
Cardiovascular Events ◽  
English Language ◽  
Data Extraction ◽  
Immediate Release ◽  
Study Selection ◽  
Effective Option ◽  
Enteric Coated Aspirin ◽  
Enteric Coated

Objective: Review the pharmacology, pharmacokinetics, efficacy, and safety of Yosprala (aspirin and omeprazole). Data Sources: A literature search was conducted using PubMed with the terms “Yosprala,” “PA8140,” and “PA32540” from the initial year through May, 2019. Additional sources were gathered through bibliographies. Aralez Pharmaceuticals Inc was contacted for manufacturer information. Study Selection and Data Extraction: The sources were narrowed to studies done in English language between 1990 and 2019. All viable clinical trials for the use of Yosprala in the secondary prevention of cardiovascular events were included. Data Synthesis: Yosprala is a coordinated delivery system of immediate-release omeprazole 40 mg and enteric-coated aspirin (325 mg or 81 mg). In 2016, the Food and Drug Administration approved Yosprala for the secondary prevention of cardiovascular or cerebrovascular events (ie, stroke or myocardial infarction). While it is recommended that patients take low-dose aspirin for secondary prevention of these events, many patients cannot tolerate the gastrointestinal (GI) adverse effect profile of the drug. Phase 3 clinical trials have proven that Yosprala significantly lowers the occurrence of GI bleeds and ulcers versus aspirin alone (3.2% and 8.6%, respectively; P ≤ .001). The most common adverse effects include infection, diarrhea, and dyspepsia. Conclusion: Yosprala significantly reduces the occurrence of GI ulcers and seems to be a safe and effective option for the secondary prevention of cardiovascular events.

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