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Powder containment hood, porcelain mortar and pestle, graduated cylinder
Triturate tablets to a fine powder with a mortar and pestle.
Levigate with a small amount of Ora-Plus to form paste.
Add Ora-Plus 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.
Transfer contents of the graduated cylinder into an appropriately sized amber bottle.
Shake well to mix.
Alternatives — May substitute vehicle with cherry syrup USP, Syrpalta, or Ora-Sweet SF.
Quality-Control Procedures — 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 in refrigerator. Shake well before use.
Storage Conditions/Stability — Refrigerate. Stable for 42 days.
Study Container Type — Amber plastic vial
Referenced Manufacturers — Ondansetron hydrochloride tablets (Zofran, GlaxoSmithKline); Ora-Plus, Ora-Sweet, Ora-Sweet SF (Paddock Laboratories, LLC); cherry syrup (Spectrum Chemical Manufacturing Corp); Syrpalta (Humco).
Stability-Indicating Study — Yes
Commercially available — Use extemporaneously prepared formulation only when commercial product is unavailable.
Williams CL, Sanders PL, Laizure SC, et al.Stability of ondansetron hydrochloride in syrups compounded from tablets. Am J Hosp Pharm. 1994;51:806–809.
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