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INGREDIENTS:

Lansoprazole 30 mg capsule12 capsules
Sodium bicarbonate 8.4% injectionQSAD: 120 mL

EQUIPMENT AND SUPPLIES:

Powder containment hood, beaker, magnetic stirrer, graduated cylinder

PREPARATION DETAILS:

  1. Open capsules and empty contents into a beaker.

  2. Add vehicle to the beaker to achieve the total volume indicated above.

  3. Place the beaker on a magnetic stirrer and stir for 30 minutes.

  4. Transfer solution into an appropriately sized amber bottle.

  5. 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.

STABILITY STUDY DETAILS:

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.

REFERENCES

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    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):600605.

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    Morrison JT, Lugo RA, Thigpen JC, et al.Stability of extemporaneously prepared lansoprazole suspension at two temperatures. J Pediatr Pharmacol Ther. 2013;18(2):122127.

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