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INGREDIENTS:

Cinacalcet 30 mg tablet20 tablets
Ora-Plus60 mL
Ora-SweetQSAD: 120 mL

EQUIPMENT AND SUPPLIES:

Powder containment hood, glass mortar and pestle, graduated cylinder

PREPARATION DETAILS:

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

  2. Levigate powder with Ora-Plus to form paste.

  3. Add Ora-Plus in increasing amounts while mixing thoroughly.

  4. Transfer contents of the mortar to a graduated cylinder.

  5. Rinse the mortar and pestle with vehicle and pour into graduated cylinder.

  6. Add vehicle to the graduated cylinder to achieve the total volume indicated above.

  7. Transfer contents of the graduated cylinder into an appropriately sized amber bottle.

  8. Shake well to mix.

Alternatives — May substitute vehicle with Ora-Sweet SF.

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 64 days.

STABILITY STUDY DETAILS:

Study Container Type — Amber oval prescription bottle with child-resistant closure

Referenced Manufacturers — Cinacalcet tablets (Sensipar, Amgen); Ora-Plus, Ora-Sweet, Ora-Sweet SF (Perrigo Co).

Stability-Indicating Study — Yes

REFERENCE

1.

Thomson K, Hutchinson DJ, Chablani L. Stability of extemporaneously prepared cinacalcet oral suspensions. Am J Health Syst Pharm. 2018;75:e236e240.

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