US Pharm. 2022;47(1):58-59.
Method of Preparation: Calculate the required quantity of each ingredient for the total amount to be prepared. Accurately weigh or measure each ingredient. Combine the carbamazepine powder with 20 mL of the SyrSpend SF PH4, and mix to form a smooth paste. Geometrically, add sufficient SyrSpend SF PH4 to final volume, with thorough mixing after each addition. Package and label.
Use: This preparation may be used in the treatment of epilepsy in pediatric patients.
Suspensions must be administered three to four times daily, in contrast with tablets, which may be administered two to four times daily; that is because a given dose of a suspension may produce higher peak and lower trough levels compared with the same dose given as a tablet. Generally, patients should be started on lower doses in order to avoid unwanted side effects. Analgesic use should be limited to the treatment of trigeminal neuralgia.
Packaging: Package in tight, light-resistant containers.
Labeling: Keep out of reach of children. Discard after ____ [time period]. Shake well.
Stability: A beyond-use date of up to 90 days may be used for this preparation when it is stored at either room temperature or refrigerated temperature.1,2
Quality Control: Quality-control assessment can include weight or volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, physical stability (discoloration, foreign materials, gas formation, mold growth), and preservative-effectiveness test.3,4
Discussion: Carbamazepine (Tegretol, C15H12N2O, MW 236.27) occurs as a white to off-white powder that is practically insoluble in water and soluble in alcohol. Carbamazepine is an iminostilbene derivative used as an anticonvulsant as well as for the relief of pain associated with trigeminal neuralgia and for other psychiatric disorders, including schizophrenia and bipolar disorder.1
SyrSpend SF PH4 is available as a liquid or a dry powder for reconstitution. The liquid form is preserved with less than 0.1% sodium benzoate and is buffered to a pH of 4.2. SyrSpend SF PH4 is available either as an unflavored or as a cherry-flavored vehicle. The powder for reconstitution is preservative free, is buffered to pH 4.2, and is available as a preweighed powder to make 100 mL (containing 6.5 g powder) or 200 mL (containing 13.0 g powder). The SyrSpend SF PH4 powder is unflavored.5
SyrSpend products include SyrSpend SF Alka Cherry (Preservative Free); SyrSpend SF Alka Unflavored (Preservative Free); SyrSpend SF Cherry; SyrSpend SF Grape; SyrSpend SF PH4 Dry (Preservative Free); SyrSpend SF Powder Dry (Preservative Free); and SyrSpend SF Unflavored. SyrSpend products are oral starch-based suspension vehicles containing a patented Active Suspending Technology that holds active pharmaceutical ingredient particles in suspension and accelerates the redistribution of suspended medication for more accurate dosing. The products are buffered to a pH of 4.2 and have low osmolality, along with bitterness masking. They are formulated without alcohol, parabens, sorbitol, carrageenan, sugars, gluten, dyes, glycerin, propylene glycol, and benzyl alcohol. The SyrSpend SF family is available as powders that require reconstitution with purified water prior to use. The SyrSpend SF Alka vehicles are buffered to a pH of greater than 7. SyrSpend SF Alka is an easy-to-use powder for reconstitution that provides an alkaline environment for acid-labile drugs.6
REFERENCES
1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial Convention, Inc; December 2021.
2. Polonini HC, Loures S, de Araujo EP, et al. Stability of allopurinol, amitriptyline hydrochloride, carbamazepine, domperidone, isoniazid, ketoconazole, lisinopril, naproxen, paracetamol (acetaminophen), and sertraline hydrochloride in SyrSpend SF PH4 oral suspensions. IJPC. 2016;20(5):426-434.
3. Allen LV Jr. Summary of quality-control testing for sterile and nonsterile compounded preparations, part 1: physical and chemical testing. IJPC. 2019;23(3):211-216.
4. Allen LV Jr. Summary of quality-control testing for sterile and nonsterile compounded preparations, part 2: microbiological testing. IJPC. 2019;23(4):299-303.
5. Fagron. Product innovations: SyrSpend SF PH4. https://fagron.com/en/product-innovations/syrspend%C2%AE-sf. Accessed December 6, 2021.
6. Fagron. SyrSpend family of products. https://us.fagron.com/en-us/syrspend-sf-family-products. Accessed December 6, 2021.
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