General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. In: United States Pharmacopeia and National Formulary (USP 43-NF 38). Revised January 1, 2014. Rockville, MD: The United States Pharmacopeia Convention Inc; 2020.
Triturate tablets to a fine powder with a mortar and pestle.
Weigh out methyl hydroxybenzoate powder, add to mortar, and mix well.
Levigate powder with a small amount of vehicle to form a paste.
Add vehicle in increasing amounts while mixing thoroughly.
Transfer contents of the mortar to a graduated cylinder.
Rinse the mortar and pestle with vehicle and pour into graduated cylinder.
Add vehicle to the graduated cylinder to achieve the total volume indicated above.
Add adequate amount of citric acid 1 M to adjust for a pH of 3.
Transfer contents of the graduated cylinder into an appropriately sized amber bottle.
Shake well to mix.
Alternatives — May substitute vehicle with 1:10 raspberry syrup and hydroxyethylcellulose 0.5% solution.
Quality-Control Procedures — Conduct pH testing to adjust for a pH of 3. Visually inspect for physical appearance of formulation and container closure integrity (no leakage, cracks in container, or improper seals).
Labeling Requirements — Extemporaneously compounded preparation. For oral use only. Store at room temperature or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 30 days.
Commercially available — Use extemporaneously prepared formulation only when commercial product is unavailable.
SosnowskaK, WinnickaK, Czajkowska-KośnikA.Stability of extemporaneous enalapril maleate suspensions for pediatric use prepared from commercially available tablets. Acta Pol Pharm. 2009;66(3):321–326.
SosnowskaK, WinnickaK, Czajkowska-KośnikA.Stability of extemporaneous enalapril maleate suspensions for pediatric use prepared from commercially available tablets. Acta Pol Pharm. 2009;66(3):321–326.)| false