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Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Antineoplastic drug: Must be prepared in compliance with USP <800>.
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 Ora-Plus with methylcellulose 1% solution and Ora-Sweet with simple syrup NF.
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. Caution: antineoplastic drug. For oral use only. Store at room temperature. Shake well before use.
Storage Conditions/Stability — Store at room temperature. Stable for 63 days.
Study Container Type — Amber glass bottle
Referenced Manufacturers — Thioguanine tablets (Lanvis, GlaxoSmithKline); Ora-Plus, Ora-Sweet (Paddock Laboratories, LLC); methylcellulose solution (Bracco Diagnostics, Inc); simple syrup (Atlas Testing Laboratories, Inc).
Stability-Indicating Study — No
Aliabadi HM, Romanick M, Somayaji V, et al.Stability of compounded thioguanine oral suspensions. Am J Health Syst Pharm. 2011;68(10):900–908.
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