Formulation in Pharmacy Practice - eMixt

Diazoxide
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Properties
Diazoxide is practically insoluble in a water, slightly soluble in alcohol and very soluble in alkaline solutions.  Diazoxide has a pKa of 8.5.  The injection is a sterile solution of the drug in water for injection made with the addition of sodium hydroxide; the pH is about 11.6.  Solutions and suspensions of diazoxide are light sensitive and may darken on exposure to heat and light.  Darkened preparations are likely to be subpotent. Oral suspensions are available in some countries and may contain parabens and about 7% ethanol.  Formal stability studies of extemporaneous preparations have not been located. 

Alternatives to compounding

In New Zealand a 50mg/ml proprietary product is available as an unregistered product. Please refer to additional important information.
Important safety note:
the proprietary product is a different strength to compounded formulations - extreme care is required to avoid confusion and possible overdose.

Compounded formulations
The following formula has been suggested (Jackson and Lowey, Handbook of Extemporaneous Preparation; Pharmaceutical Press, 2010)

Diazoxide 10 mg/mL Suspension

Diazoxide 50 mg tablets x 20
Ora-Plus 50 mL
Ora-Sweet or Ora-Plus SF to 100 mL.

Shelf-life, 7 days at room temperature. Shake the bottle.


An alternative formula is based on the information available, is as follows:


Formula
(NB only if commercial suspending base, manufactured product or "special" is not available)

Diazoxide 5mg per mL
Diazoxide tablets 25 mg 20 
*Sodium carboxymethylcellulose 400  mg
Parabens 0.1  %
Ethanol (95% or 90%) mL
Glycerol 40  mL
Water to   100  mL
*Alternatively, use methylcellulose.
Method:  Triturate the tablets or capsule contents with about 10mL
of glycerol.  Hydrate the sodium carboxymethylcellulose in about 25mL of water and add this to the crushed tablet paste when cooled.
Mix thoroughly, add the other excipients and make to volume.
Expiry:  7 days refrigerated.
It is likely that this preparation is chemically stable for at least 30 days.
 
Storage:  Protect from light
SHAKE BEFORE USE
 
 
Formulation in Pharmacy Practice
Page Updated June 2014