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Powder containment hood, glass 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 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 at room temperature. Shake well before use.
Storage Conditions/Stability — Store at room temperature. Stable for 90 days.
Study Container Type — Amber polypropylene plastic prescription bottle with child-resistant cap
Referenced Manufacturers — Rufinamide tablets (Banzel, Eisai Co, Ltd); Ora-Plus, Ora-Sweet, Ora-Sweet SF (Paddock Laboratories, LLC).
Stability-Indicating Study — Yes
Commercially available — Use extemporaneously prepared formulation only when commercial product is unavailable.
Hutchinson DJ, Liou Y, Best R, et al.Stability of extemporaneously prepared rufinamide oral suspensions. Ann Pharmacother. 2010;44(3):462–465.
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