US Pharm. 2023;48(12):59-60.
Method of Preparation: Hold the neck of the bottle containing the pantoprazole powder and tap the bottom edges on a hard surface to loosen the powder. Remove the cap from the bottle. Lightly shake DILUENT bottle, and tap the top of the cap to remove powder. Open the bottle. Tap the top of the induction seal liner on the pantoprazole bottle. Carefully and slowly peel back the inner foil seal liner on the bottle. Scrape any powder from the seal into the pantoprazole bottle. Carefully empty the contents of the DILUENT bottle into the pantoprazole powder bottle, tapping the sides to empty as much powder as possible. Measure 290 mL of purified water in a graduated cylinder. Add approximately half of the 290 mL purified water to the pantoprazole powder bottle and replace the cap. Shake the pantoprazole powder bottle vigorously for approximately 30 seconds. Add the rest of the purified water in the graduated cylinder to the pantoprazole powder bottle and replace the cap. Shake the pantoprazole powder bottle vigorously for approximately 30 seconds. Instruct patient to shake the bottle well before use. Label the product with the appropriate auxiliary labels including but not limited to: SHAKE WELL and REFRIGERATE.1
Note: As appropriate, dispense the enclosed adapter cap and oral syringe with the accompanying instructions for use. Instruct the patient in the use of the dispensed compounded suspension with the enclosed adapter cap and oral syringe.1
Use: Pantoprazole oral suspension has been used to treat a variety of gastrointestinal disorders, particularly gastroesophageal reflux disease (GERD) in pediatric patients and newborns.
Packaging: Package in the containers in which the product is provided and compounded.1
Storage: Prior to compounding, store FIRST-Pantoprazole Compounding Kit at 20°C–25°C (68°F–77°F); excursions permitted between 15°C–30°C (59°–86°F) (see USP Controlled Room Temperature). Store final compounded product at refrigerated temperature of 2°C–8°C (36°F–46°F).1
Labeling: For oral use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing.1
Stability: The beyond-use date of the compounded product, as dispensed, when stored at refrigerated temperature is not later than 30 days.1
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) are all examples of quality-control assessments.2
Discussion: Pantoprazole is a proton pump inhibitor that impacts the final step in the production of gastric acid. Its application is to treat gastrointestinal problems, particularly GERD, which is common in pediatric patients, including newborns. When a patient is intolerant to an ingredient in the manufactured products, the concentration and composition of this preparation can be easily modified to accommodate patient requirements.3
Pantoprazole sodium sesquihydrate (Protonix, C16H14F2N3NaO4S × 1.5 H2O, MW 432.4) occurs as a white to off-white, crystalline powder. This compound is racemic and possesses weakly basic and acidic properties. Pantoprazole sodium sesquihydrate is freely soluble in water, partially insoluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation of pantoprazole sodium sesquihydrate increases with decreasing pH. The degradation half-life at ambient temperature is approximately 2.8 hours at pH 5, and it is approximately 220 hours at pH 7.8.3
A commercially available liquid product that may be suited to patients’ needs is the FIRST-Pantoprazole Compounding Kit. Each FIRST-Pantoprazole Compounding Kit is comprised of bulk pantoprazole sodium USP powder and a bottle of a powder diluent blend containing benzyl alcohol, calcium carbonate, CL-611 (microcrystalline cellulose and carboxymethylcellulose sodium), colloidal silicon dioxide, peppermint flavoring, potassium acesulfame, sodium stearyl fumarate, sucralose, and trisodium phosphate dodecahydrate. The bottles will be combined at the pharmacy and reconstituted with purified water prior to dispensing. When compounded, the final product provides a homogeneous suspension containing 4 mg/mL pantoprazole.1 Store the final compounded product at refrigerated temperature of 2°C–8°C (36°F–46°F). Shake the bottle well before use. The beyond-use date of the compounded product, as dispensed, when stored at refrigerated temperature is not later than 30 days.1
Purified water is water that has been filtered through the use of distillation, ion exchange, reverse osmosis, or another suitable process. Purified water is miscible with the majority of polar solvents and is chemically stable in all physical states.4
1. Pantoprazole 4 mg/mL in FIRST-Mint Flavored Suspension Compounding Kit package insert. Woburn, MA: Azurity Pharmaceuticals; November 2023.
2. Allen LV Jr. Standard operating procedure for quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
3. Protonix (pantoprazole) product information. Philadelphia, PA: Wyeth Pharmaceuticals Inc; May 2012.
4. Dubash D, Shah U. Water. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:1012-1016.
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