US Pharm. 2021;46(2):56-57.
Method of Preparation: Calculate the required quantity of each ingredient for the total amount to be prepared. Accurately weigh or measure each ingredient. Reduce the particle size of the valsartan to a fine powder and then add a small portion of the SyrSpend SF PH4 to form a smooth paste. Geometrically, add sufficient SyrSpend SF PH4 to final volume, mixing after each addition. Package and label.
Use: Valsartan, an angiotensin II receptor antagonist, is used in the treatment of hypertension, heart failure, and left ventricular dysfunction following myocardial infarction in adults; it is also used to treat hypertension in pediatric patients aged 6 years and older. Valsartan is sometimes given in combination with other antihypertensive medications.1
Packaging: Package in tight, light-resistant containers.2
Labeling: Keep out of reach of children. Use only as directed. Shake well.
Stability: A beyond-use date of up to 90 days, when packaged in low-actinic, light-resistant prescription containers and stored at either room or refrigerated temperatures, may be used for this preparation. After 90 days, 101.50% of the intact drug was found to remain at refrigerated temperature, and 100.78% remained at room temperature.3
Quality Control: Quality-control assessment can include weight/volume, pH, specific gravity, active drug assay, color, rheologic properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).4
Discussion: Valsartan (Diovan, C24H29N5O3, MW 435.52) occurs as a white or almost white, hygroscopic powder that is freely soluble in anhydrous ethanol and is practically insoluble in water. Valsartan melts at about 117°C. Diovan, which is available as tablets for oral administration, contains 40 mg, 80 mg, 160 mg, or 320 mg of valsartan and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides (yellow, black, and/or red), magnesium stearate, microcrystalline cellulose, polyethylene glycol 8000, and titanium dioxide.1,3
SyrSpend SF PH4 is available as a liquid and as a dry powder for reconstitution. The liquid is preserved with less than 0.1% sodium benzoate, and it is buffered to a pH of 4.2. SyrSpend SF PH4 liquid is available as either an unflavored or a cherry-flavored vehicle. The powder for reconstitution is preservative free, is buffered to a pH of 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 for reconstitution 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 ingredients’ particles in suspension and accelerates 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. SyrSpend products are formulated without alcohol, parabens, sorbitol, carrageenan, sugars, gluten, dyes, glycerin, propylene glycol, and benzyl alcohol. The SyrSpend SF family of products that are available as powders 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
1. RxList. Diovan. www.rxlist.com/diovan-drug/patient-images-side-effects.htm. Accessed January 5, 2021.
2. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: United States Pharmacopeial Convention, Inc; January 2021.
3. Polonini HC, Silva SL, Cunha CN, et al. Compatibility of cholecalciferol, haloperidol, imipramine hydrochloride, levodopa/carbidopa, lorazepam, minocycline hydrochloride, tacrolimus monohydrate, terbinafine, tramadol hydrochloride and valsartan in SyrSpend SF PH4 oral suspensions. Pharmazie. 2016;71:185-191.
4. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
5. Product innovations: SyrSpend SF. https://fagron.com/en/product-innovations/syrspend%C2%AE-sf. Accessed January 5, 2021.
6. SyrSpend SF family of products. https://us.fagron.com/en-us/syrspend-sf-family-products. Accessed January 5, 2021.
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