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, ceramic mortar and pestle, graduated cylinder
Open capsules and empty contents into a mortar.
Triturate contents to a fine powder.
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.
Alternatives — May substitute vehicle with cherry syrup. Stable for 35 days when refrigerated and 5 days when stored at room temperature. Also may substitute using SyrSpend SF, which is stable for 90 days when refrigerated, or SyrSpend SF (for reconstitution), which is stable for 30 days when refrigerated.
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 35 days.
STABILITY STUDY DETAILS:
Study Container Type — Amber glass bottle and amber polyethylene terephthalate (PET) bottle with plastic cap1; low-actinic plastic prescription bottle2
WiniarskiAP, InfeldMH, TscherneR, et al.Preparation and stability of extemporaneous oral liquid formulations of oseltamivir using commercially available capsules. J Am Pharm Assoc. 2007;47(6):747–755.10.1331/JAPhA.2007.06125)| false
DijkersE, NanhekhanV, ThorissenA.Updated stability data of midazolam, oseltamivir phosphate, and propranolol hydrochloride in SyrSpend SF and minoxidil in Espumil. Int J Pharm Compd. 2017;21(3):240–241.
DijkersE, NanhekhanV, ThorissenA.Updated stability data of midazolam, oseltamivir phosphate, and propranolol hydrochloride in SyrSpend SF and minoxidil in Espumil. Int J Pharm Compd. 2017;21(3):240–241.)| false