Alprazolam

METHOD OF PREPARATION

1. Calculate the required quantity of each ingredient for the total amount to be prepared.

2. Accurately weigh and/or measure each ingredient.

3. If tablets are used, pulverize the tablets to a fine powder, or use bulk alprazolam powder.

4. Slowly add the Ora-Plus and mix, forming a smooth paste and then a uniform suspension.

5. Slowly add the Ora-Sweet, Ora-Sweet SF, or cherry syrup to volume and mix well.

6. Package and label.

PACKAGING

Package in tight, light-resistant containers.

LABELING

Keep out of reach of children. Use only as directed. Shake well before taking. Protect from light.

STABILITY

A beyond-use date of 60 days is appropriate for this preparation.1,2

USE

Generally, alprazolam is a sedative-hypnotic. It has been used in the management of anxiety disorders, for the short-term relief of symptoms of anxiety or anxiety associated with depressive symptoms, and for the management of panic disorder.3

QUALITY CONTROL

Quality-control assessment can include weight/volume, pH (pH 4.2 to 4.7 if the "Ora" family of vehicles is used, or 3.4 to 4.2 in cherry syrup), specific gravity, active drug assay, color, rheological properties/pourability, physical observation, and physical stability (discoloration, foreign materials, gas formation, mold growth).4

DISCUSSION

Alprazolam is often prepared in oral liquid dosage forms for children and elderly patients who cannot accommodate the solid tablets or when the exact dosage is not available in tablet form. In compounding this preparation, the pharmacist can use either the commercial tablet or the bulk powder. Alprazolam has the typical benzodiazepine actions.3

Alprazolam USP (C^sub 17^H^sub 13^ClN^sub 4^, MW 308.76, Xanax) occurs as a white to off-white, crystalline powder that melts at about 225°C. It is insoluble in water and soluble in alcohol.2 Alprazolam, a benzodiazepine, is commercially available as 0.25-, 0.5-, 1-, and 2-mg tablets. The Xanax brand tablets also contain cellulose, cornstarch, docusate sodium, lactose, magnesium stearate, silicon dioxide, and sodium benzoate. The 0.5-mg tablets contain FD&C Yellow No. 6, and the 1-mg tablets contain FD&C Blue No. 2.5

Ora-Plus is an oral suspending vehicle with a pH of approximately 4.2 and an osmolality of about 230 mOsm/kg. It is thixotropic, with a viscosity of approximately 1,000 cps at 25°C. It 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.6

Ora-Sweet syrup is a citrus-berry-flavored vehicle for oral extemporaneous preparations. It 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.7

Ora-Sweet SF is a sugar-free, alcohol-free syrup with a citrus-berry flavor blend. It is buffered to a pH of approximately 4.2 and may be used alone or in combination with other vehicles. It has an osmolality of 2,150 mOsm/kg. It contains water, sodium saccharin, xanthan gum, glycerin, and sorbitol; citric acid and sodium citrate as buffers; methylparaben, propylparaben, and potassium sorbate as preservatives; and flavoring agents.8

Cherry Syrup NF consists of cherry juice (475 mL), sucrose (800 g), alcohol (20 mL), and purified water (to make 1000 mL). It should be preserved in tight, light-resistant containers. Exposure to excessive heat should be prevented. It should be labeled to state the Latin binomial name and, following the official name, the part of the plant source from which it was derived. It contains from 1.0% to 2.0% alcohol. It is used as an oral vehicle.2

References

1. Allen LV Jr, Erickson MA III. Stability of alprazolam, chloroquine phosphate, cisapride, enalapril maleate, and hydralazine hydrochloride in extemporaneously compounded oral liquids. Am J Health Syst Pharm 1998; 55(18): 1915-1920.

2. US Pharmacopeial Convention, Inc. USP-Pharmacists' Pharmacopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005: 362,408-431, 668.

3. McEvoy GK, ed. AHFS Drug Information-2005. Bethesda, MD: American Society of Health-Systems Pharmacists; 2005: 2404.

4. Allen LV Jr. Standard operating procedure for quality assessment of oral and topical liquids. IJPC1999; 3(2): 146-147.

5. [No author listed.] Physicians' Desk Reference. 58th ed. Montvale, NJ: Thomson PDR; 2004: 2798-2802.

6. Ora-Plus [product information]. Minneapolis, MN: Paddock Laboratories, Inc.

7. Ora-Sweet [product information]. Minneapolis, MN: Paddock Laboratories, Inc.

8. Ora-Sweet SF [product information]. Minneapolis, MN: Paddock Laboratories, Inc.

Copyright International Journal of Pharmaceutical Compounding Nov/Dec 2005
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