US Pharm. 2021;46(5):60-CV3.
Method of Preparation: Calculate the required quantity of each ingredient for the total amount to be prepared. Accurately weigh or measure each ingredient. If atomoxetine hydrochloride (HCl) powder is used, Ora-Plus is not needed, and the finished preparation should be a solution; if capsules are used, Ora-Plus is needed to suspend the excipients. If using capsules: Empty the capsules; pulverize the contents to a fine powder and combine with the stevia. Add Ora-Plus in small portions, mixing well after each addition. Add sufficient Ora-Sweet or Ora-Sweet SF to final volume, and mix well. Package and label. If using atomoxetine HCl powder: Mix the powder and the stevia with a small quantity of Ora-Sweet or Ora-Sweet SF. Add sufficient Ora-Sweet or Ora-Sweet SF to final volume, and mix well. Package and label.
Use: Atomoxetine is a selective norepinephrine reuptake inhibitor used to treat attention-deficit/hyperactivity disorder in children and adults.
Packaging: Package preparation in tight, light-resistant containers.
Labeling: Keep out of reach of children. Discard after ____ [time period]. Refrigerate. Shake well (if suspension).
Stability: A beyond-use date of 14 days when refrigerated may be used for this preparation.1
Quality Control: Quality-control assessment can include weight/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.2,3
Discussion: Atomoxetine HCl (Strattera, C17H21NO.HCl, MW 291.82) occurs as a white to practically white solid with a water solubility of 27.8 mg/mL and a pKa of 10.13. One mg of atomoxetine is equivalent to 1.14 mg of atomoxetine HCl. Atomoxetine HCl has high aqueous solubility and biological membrane permeability that facilitates its rapid and complete absorption after oral administration. Absolute bioavailability ranges from 63% to 94% depending on interindividual differences. Atomoxetine is widely distributed and is extensively bound to plasma proteins, primarily albumin. However, it is not recommended to mix the commercial Strattera oral solution in food or water, as this may prevent the patient from receiving a full dose or could adversely affect the taste. Atomoxetine may be administered with or without food.4,5
Strattera 4 mg/mL oral solution (Lilly) is commercially available as a clear, colorless solution in the UK. Each mL contains atomoxetine HCl equivalent to 4 mg of atomoxetine, sorbitol (32.97 mg), sodium benzoate (0.8 mg), propylene glycol (9.8 mg), and sodium (2.64 mg in total), and its pH ranges from 3.7 to 4.3. Excipients in the U.S. Strattera capsules include pregelatinized starch, dimethicone, gelatin, sodium lauryl sulfate, FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide, and edible black ink.4,5
Stevia (stevioside, honey leaf, yerba dulce) is a sweetening agent about 300 times as sweet as sucrose. It is extracted from the leaves of the Stevia rebaudiana Bertoni plant and occurs as a white, crystalline, hygroscopic powder.6
Ora-Plus is an oral suspending vehicle that accepts dilution of up to 50% or more with water, flavoring agents, or syrups. It has a pH of approximately 4.2. 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.7
Ora-Sweet syrup is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend. Ora-Sweet is buffered to a pH of approximately 4.2. It contains purified water, sucrose, glycerin, sorbitol (5%), flavoring, sodium phosphate, and citric acid as buffering agents, and potassium sorbate and methylparaben as preservatives.8
Ora-Sweet SF is a sugar-free, alcohol-free syrup flavored with a citrus-berry flavor blend. It is buffered to a pH of approximately 4.2. Ora-Sweet SF contains water, sodium saccharin, xanthan gum, glycerin, sorbitol, citric acid, and sodium citrate as buffers; methylparaben, propylparaben, and potassium sorbate as preservatives; and flavoring agents.9
1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial Convention, Inc; April 2021.
2. 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.
3. Allen LV Jr. Summary of quality-control testing for sterile and nonsterile compounded preparations, part 2: microbiological testing. IJPC. 2019;23(4):299-303.
4. PubChem. Atomoxetine. https://pubchem.ncbi.nlm.nih.gov/compound/Atomoxetine. Accessed April 5, 2021.
5. Electronic Medicines Compendium. Strattera 4 mg/mL oral solution. www.medicines.org.uk/emc/product/6827/smpc. Accessed April 26, 2021.
6. Brayfield A, ed. Martindale: The Complete Drug Reference. 38th ed. London, England: Pharmaceutical Press; 2014:2214.
7. Ora-Plus product information. Allegan, MI: Perrigo; 2018.
8. Ora-Sweet product information. Allegan, MI: Perrigo; 2018.
9. Ora-Sweet SF product information. Allegan, MI: Perrigo; 2018.
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