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Powder containment hood, glass mortar and pestle, graduated cylinder
Open capsules and empty contents into a mortar.
Triturate contents to a fine powder.
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.
Transfer contents of the graduated cylinder into an appropriately sized amber bottle.
Shake well to mix.
Special Instructions — *Mix 60 mL of Ora-Plus with 60 mL of Ora-Sweet. Use mixture as vehicle or use Ora-Blend.
Alternatives — May substitute vehicle with cherry syrup.
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 or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 84 days.
Study Container Type — Polyethylene terephthalate G (PET-G) prescription bottle
Referenced Manufacturers — Rifabutin capsules (Mycobutin, Adria/Pharmacia); Ora-Plus, Ora-Sweet (Paddock Laboratories, LLC); cherry syrup (Humco).
Stability-Indicating Study — Yes
Haslam JL, Egodage KL, Chen Y, et al.Stability of rifabutin in two extemporaneously compounded oral liquids. Am J Health Syst Pharm. 1999;56:333–336.
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