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Pharmacy Times, Volume 0, 0

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

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

Chlorpromazine HCl 30 mg/mL Oral Concentrate (for100 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:

  • Calculate the quantity required for each ingredient forthe total amount to be prepared.
  • Accurately weigh and/or measure each ingredient.
  • Dissolve the chlorpromazine HCl, calcium disodiumedetate, citric acid, saccharin sodium, and sodium benzoatein approximately 25 mL of purified water.
  • Mix the hydroxypropyl methylcellulose with the propyleneglycol.
  • Slowly incorporate the aqueous solution into thepropylene glycol dispersion.
  • Add sufficient purified water to volume and mix well.
  • Package and label.

Notes:

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

Labeling suggestions: "Shake well.""Must be diluted prior toadministration."

No claims are made as to the uses, safety, efficacy, orbioavailability of this product. The formula is for informationalpurposes only.

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

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