Loyd V. Allen, Jr., PhD
Professor Emeritus
College of Pharmacy,
University of Oklahoma
Oklahoma City

Method of Preparation: Hold neck of bottle containing the omeprazole powder; tap bottom edges on a hard surface to loosen powder. Remove cap from bottle. Tap top of induction seal liner to loosen any powder adhering to liner. Carefully and slowly peel back inner foil seal liner from bottle. Using enclosed tool, scrape any omeprazole powder from seal into bottle. Using smaller end of tool, with firm strength loosen any powder from inside lower edges of bottle. Ensure that no omeprazole powder remains trapped in inside lower edges of bottle. Using tool, distribute omeprazole powder evenly over bottom surface of bottle. Shake FIRST-PPI Suspension bottle for a few seconds. Open FIRST-PPI Suspension bottle; empty about one-half of contents into omeprazole powder bottle. Replace cap; vigorously shake omeprazole powder bottle for approximately 60 seconds. Empty remaining FIRST-PPI Suspension into omeprazole powder bottle. Allow suspension to drain for 10 seconds. Replace cap; shake omeprazole powder bottle vigorously for about 30 seconds. As appropriate, dispense enclosed adapter cap and oral syringe with accompanying instructions for use.

Use: Omeprazole is a proton pump inhibitor (PPI) used to treat gastric hyperacidity.

Packaging: Package in the containers in which it is provided and compounded.

Labeling: Keep out of reach of children. Protect from light. Protect from freezing. Shake well before each use. Refrigerate. Discard after ____ [time period].

Stability: A beyond-use date of not more than 30 days when stored at refrigerated temperature may be used.

Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).

Discussion: Omeprazole (Prilosec, C₁₇H₁₉N₃O₃S, MW 345.42) occurs as a white to off-white powder that melts with decomposition at about 155°C; it is a weak base. It is very slightly soluble in water (1 g in 8,000 mL) and sparingly soluble in alcohol (1 g in 25 mL). Its degradation rate increases with decreasing acidic pH values, but it has acceptable stability under alkaline conditions.

Also available is a FIRST-Omeprazole Compounding Kit comprising omeprazole powder USP and FIRST-PPI Suspension containing artificial strawberry flavor, benzyl alcohol, FD&C Red #40, Magnasweet 100 (ammonium glycyrrhizate), poloxamer 188, propylene glycol, purified water, simethicone emulsion, sodium bicarbonate, sodium citrate (dihydrate), sucralose, and xanthan gum. The final compounded product provides a homogenous suspension containing 2 mg per mL of omeprazole in FIRST-PPI Suspension comparable to the active ingredient in Simplified Omeprazole Suspension. Read more.