Formulation in Pharmacy Practice  

CLOBAZAM
 

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No published stability studies of extemporaneously prepared clobazam suspensions have been located.

Clobazam is slightly soluble in water and at a typical concentration of 1 mg/mL most of the drug will be in suspension. Significant degradation of clobazam in aqueous suspension is not expected over short periods of use. The optimum pH for stability is not known.


Various formulations have been proposed using a variety of suspending agents such as methylcellulose or xanthan gel (Keltrol).
Reported shelf-lives range from 7 - 28 days but data are very limited.
1

 

No formal stability studies of clobazam suspension prepared with Ora-Blend or Ora-Plus, or other commercial bases have been conducted.
From the known properties of clobazam and the limited information above, the following is a suggested option;

Clobazam tablets to give a final concentration of 1 mg per mL
Base of Ora-Blend*, or a 1:1 mixture of Ora-Plus and Ora-Sweet*

*Ora-Blend SF or Ora-Sweet SF can be substituted if required.

Shelf-life 14 days at room temperature
. Refrigeration may also be suitable but it may increase the viscosity of the suspension and make it harder to re-suspend.

Shake before use : This is essential to assure uniform distribution of clobazam before the dose is given. Ensure the caregiver/patient understands the the importance of this.

Different brands of clobazam may produce suspensions with variable characteristics. A trial batch before patient use may be appropriate.

 

Further information


1. Jackson and Lowey, Handbook of Extemporaneous Preparation; Pharmaceutical Press, 2010
 

 
Formulation in Pharmacy Practice
Page Updated: September 2011