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

Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh or measure each ingredient. Hold the neck of the bottle containing the lansoprazole powder and tap the bottom edges on a hard surface to loosen the powder. Remove the cap from the bottle. Tap the top of the induction seal liner to loosen any powder adhering to the liner. Carefully and slowly peel back the inner foil seal liner from the bottle. Using the enclosed tool, scrape any lansoprazole powder from the seal into the bottle. Using the smaller end of the tool, with firm strength loosen any powder from the inside lower edges of the bottle. It is important to ensure that no lansoprazole powder remains trapped in the inside lower edges of the bottle. Again using the tool, distribute the lansoprazole powder evenly over the bottom surface of the bottle. Shake the FIRST-PPI Suspension bottle for a few seconds. Open the FIRST-PPI Suspension bottle and empty about one-half of its contents into the lansoprazole powder bottle. Replace the cap and shake the lansoprazole powder bottle for approximately 60 seconds. Shake vigorously. Empty the remaining FIRST-PPI Suspension into the lansoprazole powder bottle. Allow the suspension to drain for 10 seconds. Replace the cap and shake the lansoprazole powder bottle vigorously for approximately 60 seconds. Package and label.

Note: If appropriate, dispense the enclosed adapter cap and oral syringe with accompanying instructions for use. The adapter cap is not child resistant.

Use: Lansoprazole is indicated to treat conditions related to gastric and duodenal ulcers.

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

Labeling: Keep out of reach of children. Keep refrigerated. Shake well before each use. 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, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).

Discussion: Lansoprazole (Prevacid, C₁₆H₁₄F₃N₃O₂S, MW 369.36) occurs as a white to brownish-white powder that is sparingly soluble in ethanol and practically insoluble in water. The degradation rate of the compound in aqueous solution increases with decreasing pH.

The commercially manufactured product (Prevacid) is supplied as delayed-release capsules and as SoluTabs, available in two dosage strengths: 15 mg and 30 mg of lansoprazole per tablet. Many clinical situations require the use of a different dose or a liquid lansoprazole oral suspension, as presented here. Read more.