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.
Containment ventilated enclosure (CVE) or biological safety cabinet (BSC), porcelain mortar and pestle, graduated cylinder
Caution: Hazardous Drug—Non-antineoplastic hazardous drug: Must be prepared in compliance with USP <800>.
Open capsules and empty contents into a mortar.
Triturate contents to a fine powder.
Levigate powder with sterile water for irrigation 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 — *Cherry syrup is made with simple syrup NF (85% sucrose) with FD&C Red No. 40 (50 mg/L) and artificial cherry flavoring (1 mL/L).
Alternatives — May substitute vehicle with Ora-Plus 120 mL with artificial cherry flavoring 0.48 mL, 10% FD&C Red No. 40 0.06 mL, and aspartame 360 mg. Stable for 120 days when refrigerated or stored at room temperature, but the formulation retained an acceptable cherry odor for only 28 days when stored at room temperature.
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. Caution: hazardous drug. 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 121 days.
STABILITY STUDY DETAILS:
Study Container Type — Amber polyethylene terephthalate glycol (PET-G) bottle with child-resistant cap
Referenced Manufacturers — Mycophenolate mofetil capsules (CellCept, Hoffmann-La Roche); sterile water for irrigation (Abbott Laboratories); Red Dye (Allied Chemical Corp); cherry flavoring (Shemen Tov Corp); Ora-Plus (Paddock Laboratories, LLC); aspartame (Spectrum Chemical Manufacturing Corp).
Stability-Indicating Study — Yes
Commercially available as a 200-mg/mL suspension — Use extemporaneously prepared formulation only when commercial product is unavailable or a more dilute syrup is desired.
AnaiziNH, SwensonCF, DentingerPJ.Stability of mycophenolate mofetil in an extemporaneously compounded oral liquid. Am J Health Syst Pharm. 1998;55:926–929.
SwensonCF, DentingerPJ, AnaiziNH.Stability of mycophenolate mofetil in an extemporaneously compounded sugar-free oral liquid. Am J Health Syst Pharm. 1999;56(21):2224–2226.10.1093/ajhp/56.21.2224)| false