Hydrocortisone is only sparingly soluble in water (0.28mg per mL at 25°C)
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 |
1 |
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 - 25°C. |
|
| Storage: Amber
containers. Protect from light. |
|
| Shake
well before use |
|
|
|
|
NOTES
- 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.
- 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
- 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.
- Fawcett J.P., Boulton D.W.,
Jiang R, Woods D.J. Stability of hydrocortisone oral suspensions
Ann Pharmacother 1995; 29: 987-90.
|