Method of Preparation: Calculate the quantity of each ingredient needed. Accurately weigh or measure each ingredient. Combine the aripiprazole with a few milliliters of Ora-Plus and mix to form a smooth paste. Geometrically, add the remainder of the Ora-Plus, with thorough mixing after each addition. Incorporate sufficient Ora-Sweet to final volume and mix well. As an alternative to the combination of Ora-Plus and Ora-Sweet, Ora-Blend may be used as the vehicle. Package and label.
Use: Aripiprazole oral solution is used in the treatment of schizophrenia, the acute treatment of manic and mixed episodes associated with bipolar disorder, the adjunctive treatment of major depressive disorder, irritability associated with autistic disorder, and the treatment of Tourette syndrome. This formulation may be used in patients who cannot take the solid oral dosage forms or tolerate any of the ingredients in the commercially available aripiprazole oral solution.
Packaging: Package in tight, light-resistant, child-resistant containers.
Labeling: Keep out of reach of children. Keep refrigerated. Discard after ____ [time period]. Shake well.
Stability: A beyond-use date of up to 91 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: Aripiprazole (Abilify, MW 448.39, C23H27Cl2N3O2) is an atypical antipsychotic that occurs as a white to off-white, crystalline powder. It is insoluble in water. Aripiprazole is available as tablets, orally disintegrating tablets, oral solution, and injection.1
Commercially available Abilify Oral Solution is a clear, colorless to light-yellow solution available in a concentration of 1 mg/mL. The inactive ingredients for this solution include disodium edetate, fructose, glycerin, dl-lactic acid, methylparaben, propylene glycol, propylparaben, sodium hydroxide, sucrose, and purified water. The oral solution is flavored with natural orange cream and other natural flavors.4
Abilify tablets are available in strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. If these tablets are used as the source of the drug in this formulation, it should be noted that they also contain the following inactive ingredients: cornstarch, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Colorants include ferric oxide (yellow or red) and FD&C Blue No. 2 Aluminum Lake.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. Ora-Plus 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 it has an osmolality of about 3,240 mOsm/kg. Ora-Sweet contains purified water, sucrose, glycerin, sorbitol (5%), flavoring, sodium phosphate, and citric acid as buffering agents, and potassium sorbate and methylparaben as preservatives.6
Ora-Blend is a sweetened oral suspending vehicle used to simplify the process involved in the extemporaneous compounding of oral suspensions. It is an aqueous-based, sweetened vehicle consisting of a synergistic blend of suspending agents that have a high degree of colloidal activity. Ora-Blend is buffered to a slightly acidic pH of approximately 4.2, has a viscosity of approximately 700 cps at 25°C, and has an osmolality of 2,107 mOsm/kg. It occurs as an opaque, pinkish liquid with a sweet citrus-berry flavor. Ora-Blend contains purified water, sucrose, glycerin, sorbitol, flavoring, microcrystalline cellulose, carboxymethylcellulose sodium, xanthan gum, carrageenan, citric acid, and sodium phosphate as buffers, and simethicone as an antifoaming agent. It is preserved with methylparaben and potassium sorbate.7
1. U.S. Pharmacopeia/National Formulary [current revision]. Rockville, MD: U.S. Pharmacopeial Convention, Inc; December 2018.
2. Pramann LA, Davidow LQ, van Haandel L, Funk RS. Development of extemporaneously compounded aripiprazole oral suspensions for use in children. Int J Pharm Compd. 2016;20(3):257-261.
3. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
4. RxList. Abilify. www.rxlist.com/abilify-drug.htm. Accessed December 11, 2018.
5. Ora-Plus product information. Allegan, MI: Perrigo; 2018.
6. Ora-Sweet product information. Allegan, MI: Perrigo; 2018.
7. Ora-Blend product information. Allegan, MI: Perrigo; 2018.
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