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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 powder with glycerol to form a paste.
Add glycerol 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.
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 8 days.
Study Container Type — Amber high-density polyethylene bottle with polypropylene screw-top lid
Referenced Manufacturers — Levothyroxine sodium tablets (Eltroxin 100, GlaxoSmithKline NZ); glycerol (Pharmaceutical Sales & Marketing, Ltd); distilled water (not specified).
Stability-Indicating Study — Yes
Commercially available — Use extemporaneously prepared formulation only when commercial product is unavailable.
Boulton DW, Fawcett JP, Woods DJ. Stability of an extemporaneously compounded levothyroxine sodium oral liquid. Am J Health Syst Pharm. 1996;53:1157–1161.
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