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.
Levigate powder with orange syrup APF to form 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.
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 270 days.
STABILITY STUDY DETAILS:
Study Container Type — Amber glass bottle
Referenced Manufacturers — Prednisolone disodium phosphate powder (Roussel Uclaf Australia Pty Ltd); methylparaben powder, propylparaben powder (Sigma-Aldrich); orange syrup APF (David Craig & Co); sterile water for injection (not specified).
Stability-Indicating Study — No
Commercially available as a 1-, 2-, 3-, 4-, and 5-mg/mL sodium phosphate solution and a 3-mg/mL base solution and syrup — Use extemporaneously prepared formulation only when commercial product is unavailable or a more concentrated solution is desired.
SullivanJA, HobsonLT.Prednisolone disodium phosphate stability in a prednisolone oral solution. Aust J Hosp Pharm. 1994;24:397–398.
SullivanJA, HobsonLT.Prednisolone disodium phosphate stability in a prednisolone oral solution. Aust J Hosp Pharm. 1994;24:397–398.)| false