Albendazole 200 mg/5 mL Oral Suspension

US Pharm. 2010;35(10):104-105.

Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh/measure each ingredient. Heat »20 mL purified water to 90°C and add the sodium benzoate; allow to cool to 40°C. In a separate container, add the citric acid to a small portion of the purified water. Combine the two solutions. Separately, disperse the xanthan gum in ~40 mL purified water at 65°C, allow to hydrate, then cool to room temperature. Combine the solutions. Add the potassium sorbate and sucrose; mix well. Separately, mix the albendazole with the polysorbate 80 and sorbitol; add to the solution. Add the simethicone, flavor (a mixture of orange and vanilla has been used), and sufficient purified water to volume; mix well. Package and label.

Use: Albendazole oral liquid is used as an anthelmintic in patients who cannot swallow the commercially available tablets.

Packaging: Package in tight, light-resistant containers.

Labeling: Shake well before taking. Keep out of the reach of children. Discard after ____ [time period].

Stability: As this preparation is commercially available in some countries, a beyond-use date (BUD) of up to 6 months may be used; however, a shorter BUD is generally recommended.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).²

Discussion: Albendazole (C₁₂H₁₅N₃O₂S, MW 265.33), a synthetic benzimidazole-derivative anthelmintic agent, is structurally related to thiabendazole and mebendazole. It is used to treat tapeworm and roundworm infections. A white to faintly yellowish powder, it is practically insoluble in water and alcohol.^2,3

Simethicone (dimethyl silicone fluid, polydimethylsiloxane, dimethicone, CH₃[Si(CH₃)₂.O]nSi(CH₃)₃) occurs as a clear, colorless, odorless liquid. Simethicone is insoluble in water and alcohol.⁴

Polysorbate 80 (Tween 80, polyoxyethylene (20) sorbitan monooleate, C₆₄H₁₂₄O₂₆) has an MW of 1,310. It occurs as a yellow oily liquid with a characteristic odor and a warm, somewhat bitter taste.⁵

Xanthan gum (corn sugar gum) is a high-MW polysaccharide gum that occurs as a cream- or white-colored, odorless, free-flowing, fine powder. It is soluble in cold or warm water.⁶

Sucrose (cane sugar, beet sugar, refined sugar, saccharose) is obtained from sugar cane, sugar beet, or other sources. It occurs as colorless crystals, crystalline masses or blocks, or a white, odorless crystalline powder with a sweet taste. Sucrose is soluble in water 1:0.5, alcohol 1:400, and 95% ethanol 1:170.⁷

Sorbitol (d-glucitol, C₆H₁₄O₆, MW 182.17), a hexahydric alcohol, is isomeric with mannitol. It is an odorless, white or almost colorless, crystalline, hygroscopic powder.⁸

Sodium benzoate (C₇H₅NaO₂, MW 144.11) occurs as a white granular or crystalline, slightly hygroscopic powder. It is soluble 1 g in 1.8 mL water and 75 mL 95% ethanol.⁹

Potassium sorbate (C₆H₇O₂K, MW 150.22) occurs as a white, crystalline powder with a faint, characteristic odor. It is soluble in water (1 g in 1.72 mL), acetone (1 g in 1,000 mL), 95% alcohol (1 g in 35 mL), and propylene glycol (1 g in 1.8 mL).¹⁰

Citric acid (citric acid monohydrate, C₆H₈O₇.H₂O) occurs as colorless or translucent crystals or a white crystalline, efflorescent powder. One gram is soluble in less than 1 mL water and 1.5 mL ethanol.¹¹

REFERENCES

1. USP Pharmacists’ Pharmacopeia. 2nd ed. Rockville, MD: U.S. Pharmacopeial Convention, Inc; 2008:775-779,1422.
2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
3. McEvoy GK. AHFS 2010 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists; 2010:50-52.
4. Sweetman SC, ed. Martindale: The Complete Drug Reference. 36th ed. London, England: Pharmaceutical Press; 2009:1770-1771.
5. Zhang D. Polyoxyethylene sorbitan fatty acid esters. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:549-553.
6. Shah HC, Singh KK. Xanthan gum. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:782-785.
7. Armstrong NA. Sucrose. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:703-707.
8. Shur J. Sorbitol. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:679-682.
9. Sakurai T. Sodium benzoate. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:627-629.
10. Quinn ME, Sheskey PJ. Potassium sorbate. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:579-581.
11. Amidon GE. Citric acid monohydrate. In: Rowe RC, Sheskey PJ, Quinn ME, eds. Handbook of Pharmaceutical Excipients. 6th ed. London, England: Pharmaceutical Press; 2009:181-183.

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