US Pharm. 2023;48(5):59-60.
Method of Preparation: Calculate the exact quantity of the drug required for the total amount to be prepared. After removing the trademark imprint with a paper towel dampened with alcohol USP, allow tablets to air-dry for a few minutes. Use a mortar and pestle to triturate tablets to a fine powder. Measure appropriate amount of vehicle comprising Ora-Plus and/or Ora-Sweet. Incorporate vehicle into the powder a few millimeters at a time; then stir mixture consistently until it forms a viscous, smooth, and uniform paste. Transfer paste to a graduated cylinder and measure the volume; if necessary, add additional vehicle in sufficient quantity to final volume. Shake well before packaging.
Use: Amphetamine/dextroamphetamine is used for treatment of attention-deficit/hyperactivity disorder (ADHD) and narcolepsy. The oral suspension is recommended in patients who have difficulty swallowing pills or require a titrated dosage.
Packaging: Package in a tight, light-resistant container. Store at controlled room temperature.
Labeling: Keep out of reach of children. Keep refrigerated. Protect from light. Shake well. Discard after ____ [time period].
Stability: The USP default beyond-use date for nonpreserved aqueous oral liquids is 14 days when stored in a refrigerator.1
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).2
Discussion: Adderall contains amphetamine, which is a Schedule II controlled substance. Given the high potential for abuse, it is recommended that prescribers assess the risk of abuse prior to prescribing this medication. Adderall is a single entity composed of dextroamphetamine and amphetamine; it also contains amphetamine saccharate dextro-isomer and d, l-amphetamine aspartate dextro-isomer. Adderall contains amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate in a 3:1 ratio of d-amphetamine to l-amphetamine salts.3 These compounds are neutral sulfate salts of amphetamine and dextroamphetamine that are formed by a reaction with sulfuric acid.
Amphetamines, which are a type of noncatecholamine sympathomimetic amine, have a stimulating effect on the central nervous system (CNS). In racemic form, amphetamines differ from dextroamphetamine in that the l-isomer is more potent in its cardiovascular activity but much less potent in its excitatory effects on the CNS. The salt form, amphetamine sulfate ((C9H13N)2 • H2SO4, MW 368.5), is a white, crystalline powder that has no odor and a slightly bitter taste. Amphetamine sulfate dissolves easily in water (with a pH of 5-6) and is slightly soluble in alcohol.4
Immediate-release tablets (available in strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg) should be used to prepare this oral suspension. A stability study of Adderall as an oral liquid used the 10-mg tablet, which contains amphetamine aspartate 2.5 mg, amphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, and dextroamphetamine sulfate 2.5 mg.4 The tablets contain microcrystalline cellulose and colloidal silicon dioxide as inactive ingredients. The 7.5-mg and 10-mg tablets also contain FD&C Blue #1, and the 12.5-mg, 15-mg, 20-mg, and 30-mg tablets contain FD&C Yellow #6; the 5-mg tablet contains no color additives.
Ora-Plus is an oral suspending liquid that exhibits thixotropic behavior. It can be diluted with up to 50% or more of water, flavorings, or syrups without losing its suspending properties. Ora-Plus has a viscosity of approximately 1,000 cps at 25°, a pH of around 4.2, and an osmolality of 230 mOsm/kg. Its ingredients include purified water, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, sodium phosphate, citric acid, simethicone as an antifoaming agent, and potassium sorbate and methylparaben as preservatives.5
Ora-Sweet is an oral syrup vehicle that is commonly used to mask the taste of bitter medications. The pH of Ora-Sweet is approximately 4.2, and the osmolality is around 3,450 mOsm/kg. Its ingredients include purified water, sucrose, glycerin, sorbitol, flavorings, sodium phosphate, and citric acid as buffering agents and potassium sorbate and methylparaben as preservatives.6
REFERENCES
1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial Convention, Inc; September 2022.
2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
3. Adderall (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate). Horsham, PA: Teva Pharmaceuticals USA; December 2016.
4. Justice J, Kupiec TC, Matthews P, Cardona P. Stability of Adderall in extemporaneously compounded oral liquids. Am J Health Syst Pharm. 2001;58(15):1418-1421.
5. Ora-Plus product information. Allegan, MI: Perrigo Laboratories; 2019.
6. Ora-Sweet product information. Allegan, MI: Perrigo Laboratories; 2019.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
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