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, beaker, magnetic stirrer, graduated cylinder, 2 x 18-G needle, 2 x 60 mL syringe
Open capsules and empty contents into a beaker.
Add vehicle to the beaker to achieve the total volume indicated above.
Place the beaker on a magnetic stirrer and stir for 30 minutes.
Transfer solution into an appropriately sized amber bottle.
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 at room temperature or refrigerate. Shake well before use.
Storage Conditions/Stability — Store at room temperature or refrigerate. Stable for 45 days in plastic amber syringe when refrigerated and 14 days when stored at room temperature. Stable for 30 days in glass vial when refrigerated and 14 days when stored at room temperature.
STABILITY STUDY DETAILS:
Study Container Type — Amber plastic syringe and glass vial
DiGiacintoJL, OlsenKM, BergmanKL, et al.Stability of suspension formulations of lansoprazole and omeprazole stored in amber-colored plastic oral syringes. Ann Pharmacother. 2000;34(5):600–605.10.1345/aph.19086)| false