Although traditionally compounded omeprazole suspension and the FIRST Omeprazole Suspension Kit have similar storage requirements and potency retention, researchers have found that the active pharmaceutical ingredient (API) concentration in the FIRST Omeprazole suspension is more consistent from batch to batch than traditionally compounded omeprazole suspensions.

Omeprazole is a proton pump inhibitor (PPI) frequently used for the treatment of gastrointestinal conditions, such as gastrointestinal esophageal reflux disease. It is typically prepared as an oral suspension using sodium bicarbonate in order to accommodate certain patients. FIRST Omeprazole Kits offer a pre-measured option for pharmacists dispensing suspended Omeprazole.

Researchers compared traditionally compounded Omeprazole suspension with the FIRST Omeprazole Kit, in an effort to compare the stability of the API in both. Both samples were aliquoted into 5-mL doses in clear Luer-lock plastic oral syringes, before being stored in refrigerators.

On sampling days 0, 7, 14, 21, and 30, 3 syringes from each batch were combined with 5 mL of acetonitrile and water in order to reach assay concentrations. These samples were then analyzed using a validated high-performance liquid chromatography with ultraviolet detection methods.

On the day of compounding, the average omeprazole concentration measured was approximately 1.942 mg/mL for the FIRST Omeprazole Kit, and approximately 1.796 mg/mL for traditionally compounded omeprazole. On day 30, the average concentration was approximately 1.924 mg/mL for FIRST omeprazole kit, and approximately 1.688 mg/mL for the traditional omeprazole compound.

The students concluded from this data that the FIRST Omeprazole suspension can be stored for the duration of the product’s 30 days and still retain potency between 90% and 110% of the initial concentration or label claim.

Remonica Jackson, BS, MS, PharmD candidate, who was one of the researchers from the Bill Gatton College of Pharmacy at East Tennessee State University, noted that health care professionals typically advise patients not to take a PPI after 14 days due to the decrease in potency. The FIRST kit, however, may offer a solution to that time limitation.

“Now, you can tell your patients that there is a drug [available], if you want to be on long-term PPIs,” Jackson said in an interview with Pharmacy Times.

REFERENCE
Jackson R, Brown S, Lewis P. Comparative stability of compounded omeprazole suspension versus commercial omeprazole kit when stored in oral syringes under refrigerated conditions [poster]. Presented at 2019 American Society of Health-System Pharmacists (ASHP) Midyear Meeting.