Compounding HOTLINE

Q: Have you a formulation for chlorpromazine liquid 30 mg/mL oral concentrate?

A:Chlorpromazine hydrochloride (HCl) is a white to creamy-white, odorless powder with crystalline texture. It is very soluble in water and freely soluble in alcohol (ethanol). The commercially manufactured drug product was discontinued. The following formulation was published in 2003 (IJPC.7[4]:297).

Chlorpromazine HCl 30 mg/mL Oral Concentrate (for 100 mL):

Chlorpromazine HCl 3.000 g

Calcium disodium edetate 0.200 g

Citric acid 0.200 g

Saccharin sodium 0.100 g

Sodium benzoate 0.200 g

Purified water qs ad 100.000 mL

Hydroxypropyl methylcellulose 0.250 g

Propylene glycol 10.000 mL

Suggested Method of Preparation:

1. Calculate the quantity required for each ingredient for the total amount to be prepared.
2. Accurately weigh and/or measure each ingredient.
3. Dissolve the chlorpromazine HCl, calcium disodium edetate, citric acid, saccharin sodium, and sodium benzoate in approximately 25 mL of purified water.
4. Mix the hydroxypropyl methylcellulose with the propylene glycol.
5. Slowly incorporate the aqueous solution into the propylene glycol dispersion.
6. Add sufficient purified water to volume and mix well.
7. Package and label.

Notes:

Chlorpromazine HCl is photosensitive. Store and dispense in tight, light-resistant containers.

Labeling suggestions: "Shake well.""Must be diluted prior to administration."

No claims are made as to the uses, safety, efficacy, or bioavailability of this product. The formula is for informational purposes only.

Mr. Erickson is director of professional affairs at Gallipot Inc.

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