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Pantoprazole Solution 2 mg/mL—Formulation 1

in Extemporaneous Formulations
Authors:
Rita K. Jew
,
Winson Soo-Hoo
,
Elham Amiri
, and
Jamie M. Gomes
Free access

INGREDIENTS:

Pantoprazole 40 mg tablet6 tablets
Sodium bicarbonate powder10.1 g
Sterile water for irrigationQSAD: 120 mL

EQUIPMENT AND SUPPLIES:

Powder containment hood, mortar and pestle, beaker, magnetic stirrer, graduated cylinder, pharmaceutical analytical scale

PREPARATION DETAILS:

  1. Remove imprint from tablets by gently rubbing with a paper towel dampened with ethanol.

  2. Allow tablets to air-dry for a few minutes.

  3. Triturate tablets to a fine powder with a mortar and pestle.

  4. Transfer the contents of the mortar to an appropriately sized beaker.

  5. Add 100 mL of sterile water for irrigation and place the beaker on a magnetic stirrer.

  6. Add 5 g of sodium bicarbonate powder and continue to stir for approximately 20 minutes until all tablet remnants have disintegrated and the coating has dissolved.

  7. Add remaining sodium bicarbonate powder and stir for approximately 5 minutes until the powder dissolves.

  8. Add enough sterile water for irrigation to achieve the final volume indicated.

  9. Transfer the solution into an appropriately sized amber bottle.

  10. 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 62 days.

STABILITY STUDY DETAILS:

Study Container Type — Amber polyethylene terephthalate (PET) bottle with child-resistant cap

Referenced Manufacturers — Pantoprazole tablets (Protonix, Wyeth-Ayerst Laboratories); sterile water for irrigation (Abbott Laboratories); sodium bicarbonate powder (Spectrum Chemical Manufacturing Corp).

Stability-Indicating Study — Yes

REFERENCE

1.

Dentinger PJ, Swenson CF, Anaizi NH. Stability of pantoprazole in an extemporaneously compounded oral liquid. Am J Health Syst Pharm. 2002;59:953956.

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