General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. In: United States Pharmacopeia and National Formulary (USP 43-NF 38). Revised January 1, 2014. Rockville, MD: The United States Pharmacopeia Convention Inc; 2020.
Powder containment hood, glass mortar and pestle, graduated cylinder
Triturate tablets to a fine powder with a mortar and pestle.
Levigate powder with a small amount of vehicle to form a paste.
Add vehicle 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.
Special Instructions — *Mix 60 mL of Ora-Plus with 60 mL of Ora-Sweet. Use mixture as vehicle or use Ora-Blend. Bitter aftertaste. May administer chocolate syrup before medication administration or mix the preparation with chocolate syrup (1:1 by volume) immediately before administration to mask the bitter aftertaste.
Alternatives — May substitute vehicle with 60 mL of Ora-Plus mixed with 60 mL of Ora-Sweet SF or Ora-Blend 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. Shake well before use.
Storage Conditions/Stability — Store at room temperature. Stable for 90 days.
STABILITY STUDY DETAILS:
Study Container Type — Amber plastic prescription bottle with child-resistant cap