Formulation in Pharmacy Practice   2nd Edition

FLUDROCORTISONE
 
Fludrocortisone acetate is insoluble in water and sparingly soluble in alcohol.
Formal stability studies of suspensions of fludrocortisone have not been located.

This formula is based on a previous recommendation by the manufacturer of Florinef ® tablets.

Formula

Fludrocortisone Suspension
 
Fludrocortisone acetate tablets qs   
Sodium Carboxymethylcellulose g
Syrup 10  mL
Parabens 0.1  %
Citric acid monohydrate 600  mg
Lemon spirit (optional) 0.25  mL
Water to   100  mL
 
If available 0.5mL of polysorbate 80 can be used to wet the crushed tablets.  Alternatively use ethanol.
 
Expiry:  Two weeks
 
Stability:   The suspension is reported to be stable for 44 days in amber glass bottles, but no details of the study are available.
 
Storage:  Refrigerate
 
Shake well before use
 

 
NOTES
  1. Alternative flavouring agents (e.g. chocolate or caramel) could be tried.  Mix the flavouring agent with the dose just before administration.
  2. Dose uniformity is essential and it is important to evaluate and observe the physical properties of the suspension.  Caregivers should be counselled on the importance of re-suspension.
  3. Tablets usually disperse very easily and this option should be considered if the dose is a whole tablet or easily measured fraction.
    N.B.  As the drug is insoluble measurement of a dose aliquot from a tablet dispersion may lead to erratic and innaccurate dosing.
  4. Some pharmacists prefer to make powders or repacked capsules.

 
Formulation in Pharmacy Practice
2nd Edition