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), graduated cylinder, beaker, hot plate, thermometer
Caution: Hazardous Drug—Non-antineoplastic hazardous drug: Must be prepared in compliance with USP <800>.
Place capsules in a 30-mL oral syringe.
Add hot water (55°C) to the oral syringe.
Let mixture stand for 10 minutes.
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. Caution: hazardous drug. For oral use only. Store at room temperature. Shake well before use.
Storage Conditions/Stability — Store at room temperature. Stable for 24 hours.
STABILITY STUDY DETAILS:
Study Container Type — Plastic syringe
Referenced Manufacturer — Lenalidomide capsules (Celgene Corp); sterile water for irrigation (not specified).
Stability-Indicating Study — No
MoritaTO, YamaguchiA, KimuraS, et al.Stability of lenalidomide suspension after preparation by a simple suspension method for enteral tube administration. J Oncol Pharm Pract.2016;22(4):579–583.
MoritaTO, YamaguchiA, KimuraS, et al.Stability of lenalidomide suspension after preparation by a simple suspension method for enteral tube administration. J Oncol Pharm Pract. 2016;22(4):579–583.)| false