US Pharm. 2014;39(11):54-55.
Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh or measure each ingredient. In a glass or porcelain mortar, pulverize the tablets with a pestle to a fine powder. Add a few milliliters of Ora-Plus to the powder and mix to form a smooth paste. Geometrically, add the remainder of the Ora-Plus and mix well. Add the Ora-Sweet to volume and mix well. Package and label.
Use: Adderall oral liquid has been used in the treatment of attention-deficit/hyperactivity disorder in patients who are unable to swallow the oral dosage form or in cases when the dosage needs to be titrated.
Packaging: Package in tight, light-resistant containers.
Labeling: Keep out of reach of children. Discard after ____ [time period]. Use only as directed. Shake well.
Stability: A beyond-use date of 30 days may be used for this preparation.1,2
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).3
Discussion: Adderall is a single-entity amphetamine product that combines the neutral sulfate salts of dextroamphetamine and amphetamine with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate. It contains the d-amphetamine and l-amphetamine salts in the ratio of 3 to 1. Adderall consists of a mixture of amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate.
Amphetamine sulfate ((C9H13N)2.H2SO4, MW 368.49) occurs as a white, odorless, crystalline powder with a slightly bitter taste. In aqueous solution, it has an acid reaction to litmus, with a pH of 5 to 6. It is freely soluble in water and slightly soluble in alcohol.1
The regular immediate-release Adderall tablets should be used for this preparation, and they are available in strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg. The 10-mg strength used in the referenced stability study consists of 2.5 mg amphetamine aspartate, 2.5 mg amphetamine sulfate, 2.5 mg dextroamphetamine saccharate, and 2.5 mg dextroamphetamine sulfate.2 The inactive ingredients include microcrystalline cellulose, colloidal silicone dioxide, and FD&C Blue #1 (in the 7.5-mg and 10-mg tablets). The Adderall 5-mg strength has no color additives; the 12.5-mg, 15-mg, 20-mg, and 30-mg strengths contain FD&C Yellow #6 as a color additive.4
Ora-Plus is an oral suspending vehicle that accepts dilution of up to 50% or more with water, flavoring agents, or syrups while still retaining its suspending properties. It has a pH of approximately 4.2 and an osmolality of about 230 mOsm/kg. It is a thixotropic vehicle with a viscosity of approximately 1,000 cps at 25°C. Ora-Plus contains purified water, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, sodium phosphate, and citric acid as buffering agents, simethicone as an antifoaming agent, and potassium sorbate and methylparaben as preservatives.5
Ora-Sweet syrup vehicle is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend and contains glycerin and sorbitol to prevent cap lock, a problem associated with many syrups. Ora-Sweet is buffered to a pH of approximately 4.2 and has an osmolality of about 3,240 mOsm/kg. It contains purified water, sucrose, glycerin, sorbitol (5%), flavoring, sodium phosphate, and citric acid as buffering agents, and potassium sorbate and methylparaben as preservatives.6
REFERENCES
1. U.S. Pharmacopeia 37/National Formulary 32. Rockville, MD: U.S. Pharmacopeial Convention, Inc; 2014:403-410,1783-1785, 2568-2571.
2. Justice J, Kupiec TC, Matthews P, Cardona P. Stability of Adderall in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 2001;58:1418-1421.
3. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
4. Physicians’ Desk Reference. 67th ed. Montvale, NJ: PDR Network; 2013:2273-2279.
5. Ora-Plus product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.
6. Ora-Sweet product information. Minneapolis, MN: Paddock Laboratories, Inc; 2010.
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