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 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.
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 90 days.
STABILITY STUDY DETAILS:
Study Container Type — Low-actinic, light-resistant prescription bottle
Referenced Manufacturer — Baclofen powder, SyrSpend SF PH4 (Fagron).
Stability-Indicating Study — Yes
Commercially available as a 1-mg/mL solution — Use extemporaneously prepared formulation only when commercial product is unavailable or a more concentrated suspension is desired.
FerreiraAO, PoloniniH, da SilvaSL, et al.Stability of acetazolamide, baclofen, dipyridamole, mebeverine hydrochloride, propylthiouracil, quinidine sulfate, and topiramate oral suspensions in SyrSpend SF PH4. Int J Pharm Compd.2017;21(4):339–346.
FerreiraAO, PoloniniH, da SilvaSL, et al.Stability of acetazolamide, baclofen, dipyridamole, mebeverine hydrochloride, propylthiouracil, quinidine sulfate, and topiramate oral suspensions in SyrSpend SF PH4. Int J Pharm Compd. 2017;21(4):339–346.)| false