Lansoprazole 3 mg/mL Suspension

US Pharm. 2020;45(11):46-47.

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.^1,2

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).³

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.¹ The degradation rate of the compound in aqueous solution increases with decreasing pH.^1,4

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.

Each FIRST-Lansoprazole Compounding Kit comprises lansoprazole 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. When compounded, the final product provides a homogenous suspension containing 3 mg per mL of lansoprazole.²

Artificial strawberry flavor: This typically contains more than 40 individual chemical substances.⁵

Benzyl alcohol (C₇H₈O, MW 108.14), an antimicrobial preservative, is a clear, colorless, oily liquid with a faint, aromatic odor and a sharp, burning taste. It is soluble 1 g in 25 mL of water.⁶

FD&C Red #40 (C₁₈H₁₄N₂Na₂O₈S₂ 496.42 g·mol⁻¹, Allura Red AC, FD&C Red 40, E129, Food Red 17) is a red azo dye that occurs as a red powder usually supplied as its red sodium salt that is soluble in water.⁷

Magnasweet (ammonium glycyrrhizate, C₄₂H₆₅NO₁₆-anhydrous, MW 840.08; C₄₂H₆₅NO₁₆.5H₂O-pentahydrate, MW 930.04) occurs as a white to yellowish-white or brown, hygroscopic powder with an intensely sweet taste. It is used as a sweetening, flavoring, taste-masking, and emulsifying agent. It is slightly soluble in water.⁸

Poloxamer 188 is a block copolymer of ethylene oxide and propylene oxide that occurs as white-colored, waxy, free-flowing granules that are practically odorless and tasteless. The poloxamers are used as emulsifying agents, solubilizing agents, and wetting agents. Poloxamer 188 is freely soluble in water.⁹

Propylene glycol (C₃H₈O₂) occurs as a clear, colorless, viscous, hygroscopic, practically odorless liquid with a sweet taste somewhat resembling glycerin. It is miscible with water.¹⁰

Simethicone {CH₃[Si(CH₃)₂.O]nSi(CH₃)₃} is a fluid silicone that occurs as a clear, colorless, odorless liquid that is insoluble in water.¹¹

Sodium bicarbonate (baking soda, sal de Vichy, NaHCO₃, MW 84.01) occurs as a white, crystalline powder that is stable in dry air, but it slowly decomposes in moist air. Sodium bicarbonate is soluble in water (1 g in 10-12 mL).^1,12

Sodium citrate dihydrate (trisodium citrate, C₆H₅Na₃O₇, MW 258.07, anhydrous; dihydrate, MW 294.10) occurs as colorless crystals or as a white, crystalline powder. The hydrous form is freely soluble in water (1 g in 1.5 mL).¹³

Sucralose (Unisweet, C₁₂H₁₉Cl₃O₈, MW 397.64) is a white to off-white, free-flowing, crystalline powder. It is freely soluble in water (0.283 g/mL).¹⁴

Xanthan gum (corn sugar gum) is a high-molecular-weight polysaccharide gum. It occurs as a cream-colored or white, odorless, free-flowing fine powder that is soluble in cold or warm water. Xanthan gum is used as a viscosity-increasing agent in suspensions.¹⁵

REFERENCES

1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial Convention, Inc; April 2019.2. FIRST-Lansoprazole package insert. Wilmington, MA: Cutis Pharma; November 2016.
3. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.4. Allen LV Jr, ed. Remington: The Science and Practice of Pharmacy. 22nd ed. London, England: Pharmaceutical Press; 2013:1649.
5. Artificial strawberry flavoring. www.feingold.org/strawberry.html. Accessed April 25, 2019.6. Quinn ME. Benzyl alcohol. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:108-110.
7. Rappoport Z, ed. The Chemistry of Phenols. Chichester, England: John Wiley & Sons; 2004.8. Quinn ME. Ammonium glycyrrhizate. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:73-74.
9. Pirjanian A, Alvarez-Nunez F. Poloxamer. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:688-693.10. Driver S. Propylene glycol. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:795-798.
11. Sweetman SC, ed. Martindale: The Complete Drug Reference. 36th ed. London, England: Pharmaceutical Press; 2009:1770-1771.12. Quinn ME. Sodium bicarbonate. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:846-850.13. Amidon GE. Sodium citrate dihydrate. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:858-860.14. Hutchins A, Mullarney MP. Sucralose. In: Sheskey PJ, Cook WG, Cable CG, eds. Handbook of Pharmaceutical Excipients. 8th ed. London, England: Pharmaceutical Press; 2017:937.
15. Shah HC, Singh KK. Xanthan gum. In: Rowe RC, Sheskey PJ, Cook WG, Fenton ME, eds. Handbook of Pharmaceutical Excipients. 7th ed. Washington, DC: American Pharmaceutical Association; 2012:897-900.

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