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Powder containment hood, beaker, magnetic stirrer, graduated cylinder
Open capsules and empty contents into a beaker.
Add vehicle to the beaker to achieve the total volume indicated above.
Place the beaker on a magnetic stirrer and stir for 30 minutes.
Transfer solution 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 7 days.
Study Container Type — Amber plastic oral syringe
Referenced Manufacturers — Lansoprazole capsules (Prevacid, TAP Pharmaceuticals); sodium bicarbonate injection (Abbott Laboratories).
Stability-Indicating Study — Yes
Footnote — According to DiGiacinto et al,1 stable for 14 days when refrigerated. According to Morrison et al,2 stable for 7 days when refrigerated. Used conservative stability dating of 7 days.
DiGiacinto JL, Olsen KM, Bergman KL, et al.Stability of suspension formulations of lansoprazole and omeprazole stored in amber-colored plastic oral syringes. Ann Pharmacother. 2000;34(5):600–605.
Morrison JT, Lugo RA, Thigpen JC, et al.Stability of extemporaneously prepared lansoprazole suspension at two temperatures. J Pediatr Pharmacol Ther. 2013;18(2):122–127.
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