A New Zealand standardised
formulation is available Formula
and Batch Sheet
This formula uses Ora-Blend/SF or Ora-Plus and Ora-Sweet/SF; 1:1, and has
been approved by the Extemporaneous Compounding Pharmacists' Group.
Alternatives are given below.
Diltiazem hydrochloride is soluble
in water. An injectable preparation, 5mg per mL, is available
in some countries and could be administered orally. Formula A
is from a published study. Formula B is a suggested alternative
based on stability information.
Formula
A1
Diltiazem 12mg per mL |
|
| Diltiazem
hydrochloride tablets 90mg |
16 |
|
| *Vehicle |
to 120 |
mL |
|
*Vehicle
A 1:1 mixture of Ora Sweet®
and Ora Plus®,
or a 1:1 mixture of Ora Sweet SF®
and Ora Plus®,
or cherry syrup (cherry syrup concentrate diluted
1:4 with simple syrup). |
|
| Expiry: 30
days |
|
| Stability:
These preparations are chemically stable
for 60 days but microbial testing and stability
under in use conditions were not evaluated. |
|
| Storage: Protect
from light. |
|
| Shake
well before use |
| |
|
|
|
NOTES
- The final pH of
the formulations investigated by Allen and Ericksen was in the range
3.5 - 4.2.1
- Sulieman et
al2 investigated the stability of 1mg per mL solutions
containing one of the following sugars; dextrose 0.28M, fructose 0.28M,
sorbitol 0.28M or 0.56M, sucrose 0.28M.
Diltiazem potency was maintained for at least 50 days at 25°C. The
initial pH of the solutions ranged from 4.3 - 6.3.
Formula
B
Diltiazem Oral Liquid |
| |
| Diltiazem
hydrochloride tablets |
qs |
|
| Glycerol |
40 |
mL |
| Syrup |
10 |
mL |
| Parabens |
0.1 |
% |
| *Citric
acid |
qs |
|
| Water |
to 100 |
mL |
|
| *If
possible check the final pH. If the pH
is greater than 6 add a small amount of citric acid
(50 - 100mg) to bring the final pH
approximately in the range 4 - 6. |
|
| Expiry: 30
days |
|
| Storage: Refrigerate. Protect
from light (amber container). |
|
| Shake
well before use |
| |
|
|
|
REFERENCES
- Allen L. V., Erickson M.
A. Stability of baclofen, captopril, diltiazem hydrochloride,
dipyridamole, and flecainide acetate in extemporaneously compounded
oral liquids. Am J Health-Syst Pharm, 1996; 53
(Sep15); 2179-2184.
- Sulieman MS, Najib NM, Abdelhameed
ME. Stability of diltiazem hydrochloride in aqueous sugar
solutions.
J Clin Pharm Ther 1988; 13: 417-22.
|