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, mortar and pestle, graduated cylinder
Open capsule 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 Gatorade Thirst Quencher Lemon Lime, Ocean Spray Cran-Grape Drink, Speas Farm Apple Juice or V8 100% Vegetable Juice. Stable for 2 days when refrigerated or when stored at room temperature for all alternative vehicles except Ocean Spray Cran-Grape (2 days when refrigerated; 8 hours when stored at room temperature) and V8 100% Vegetable Juice (2 days when refrigerated; 1 day when stored at room temperature).
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 2 days.
STABILITY STUDY DETAILS:
Study Container Type — Unknown
Referenced Manufacturers — Nizatidine capsule (Axid, Eli Lilly and Co); water (not specified); Gatorade Thirst Quencher (Stokely-Van Camp, Inc); Ocean Spray Cran-Grape (Ocean Spray Cranberries); Speas Farm Apple Juice (Sundor Brands, Inc); V8 100% Vegetable Juice (Campbell Soup Co).
Stability-Indicating Study — Yes
Commercially available as a 15-mg/mL solution — Use extemporaneously prepared formulation only when commercial product is unavailable or a more dilute solution is desired.
LantzMD, WozniakTJ.Stability of nizatidine in extemporaneous oral liquid preparations. Am J Hosp Pharm. 1990;47(12):2716–2719.
LantzMD, WozniakTJ.Stability of nizatidine in extemporaneous oral liquid preparations. Am J Hosp Pharm. 1990;47(12):2716–2719.)| false