Formulation in Pharmacy Practice  eMixt

HYDROCORTISONE
 
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Hydrocortisone is only sparingly soluble in water (0.28mg per mL at 25C) and in solution it undergoes degradation to yield a number of products.1
The minimum rate of degradation occurs at about pH 4.  Hydrocortisone is stable at room temperature in aqueous solutions buffered to pH 3.5.2

A New Zealand standardised formulation is available Formula and Batch Sheet
This formula uses Ora-Blend or Ora-Plus and Ora-Sweet; 1:1, and has been approved by the Extemporaneous Compounding Pharmacists' Group.

An alternative formula is given below if this base is not available.


Formula 2

Hydrocortisone 2.5mg per mL
Hydrocortisone tablets 20mg 12.5  tablets
*Polysorbate 80 0.5  mL
#Sodium carboxymethylcellulose g
Syrup BP 10  mL
Parabens 0.1  %
Citric acid monohydrate 600  mg
Water to   100  mL
*Polysorbate 80 helps to wet the hydrocortisone.  Triturate with the powder (or crushed tablets) before adding the other ingredients.  If not available a small volume of glycerol may help to initially disperse the hydrocortisone.

#Use methylcellulose 1% as an alternative.
Expiry/Stability:  30 days at 5 - 25C.
Storage:  Amber containers.  Protect from light.
Shake well before use

 
NOTES
  1. This preparation has a very bitter flavour that can be improved by following a dose by a glass of water, or by adding a flavour concentrate before giving the dose.
  2. If available, the use of hydrocortisone powder is preferred.  The use of more soluble esters of hydrocortisone is not recommended, as they may have reduced oral bioavailability compared with the free alcohol.

REFERENCES
  1. Fleisher D.  Hydrocortisone.  In: Conners K.A., Amidon G.L., Stella V.J., eds.  Chemical stability of pharmaceuticals: a handbook for pharmacists. 2nd ed.  New York:John Wiley and Sons, 1986: 483-95.
  2. Fawcett J.P., Boulton D.W., Jiang R, Woods D.J.  Stability of hydrocortisone oral suspensions
    Ann Pharmacother 1995; 29: 987-90.

 
Formulation in Pharmacy Practice
2nd Edition
Page Last Updated Augst 2011