Hospital Pharmacy - December 2017 - 759

759

Reindel et al.
Table 3. Mean Concentration (%) of Eslicarbazepine in the
Prepared Suspensions (40 mg/mL).
Eslicarbazepine concentration, mean (%)
Trial
1
2

Sample 1

Sample 2

Sample 3

Average

95.9
101.7

98.9
101.1

98.7
99.1

98 ± 0.02
101 ± 0.01

Table 4. Mean Concentration (%) of Eslicarbazepine in the
Prepared Suspension (40 g/mL) After Passing Through Enteric
Feeding Tubes.
Eslicarbazepine concentration, mean (%)
Tube type

Sample 1

Sample 2

Sample 3

Average

101.5
101.7
102.5

103.6
104.3
103.3

102.6
100.8
103.9

102.6 ± 1.1
102.3 ± 1.8
103.2 ± 0.7

PVC, 18 Fr, 48″
PVC, 10 Fr, 36″
Polyurethane,
10 Fr, 36″

Table 5. Mean Concentration (%) of Eslicarbazepine in the
Prepared Suspension (40 mg/mL) Following 24- and 48-Hour
Storage at Room Temperature.
Eslicarbazepine concentration, mean (%)
Time

Sample 1

Sample 2

Sample 3

Average

0h
24 h
48 h

104.0
103.0
103.0

102.0
97.0
102.0

104.0
104.0
105.0

103.3 ± 1.2
101.3 ± 3.8
103.3 ± 1.5

Stability of Optimized Eslicarbazepine Acetate
Suspension
The prepared eslicarbazepine acetate suspension was subjected to a 48-hour stability study at room temperature. The
suspensions were analyzed for eslicarbazepine concentrations
at time 0 (initial concentration), at 24 hours, and at 48 hours.
As shown in Table 5, the mean eslicarbazepine concentrations
in the prepared suspensions ranged between 101% and 104%.
The storage did not appear to have an influence on the chemical stability of the suspensions. Visual inspection revealed
that the suspension remained uniform for the duration of storage, with no observed settling behavior. While carbamazepine has been reported to adhere to certain types of delivery
tubes, these results indicate that eslicarbazepine suspension
(eslicarbazepine acetate suspension, 40 mg/mL) prepared
using ORA-Plus:water (50:50 v/v) as suspending vehicle
does not interact physically or chemically to the plastic tubing, thus making it suitable for delivery though PVC/18
Fr/48″, PVC/10 Fr/36″, and Polyurethane/10 Fr/36″ tubes.16
A general guideline procedure to be used by the health care
professionals for the preparation of a stable eslicarbazepine
acetate suspension using Aptiom tablets is shown in Appendix.

Conclusions
A 40 mg/mL suspension of eslicarbazepine acetate in ORAPlus:water (50:50 v/v) was identified as suitable for administration through enteral feeding tubes. The concentration of
eslicarbazepine after passing through the selected enteric
feeding tubes was found to be within acceptable range
(±10%) of the label claim. The eslicarbazepine acetate suspension in ORA-Plus:water (50:50 v/v) was found to be the
easiest to prepare, and stable at room temperature for 48
hours without compromising the integrity of the suspension.
The study presents the feasibility of preparing an extemporaneous suspension of eslicarbazepine for delivery via enteric
feeding tubes, using Aptiom tablets.

Appendix
General guideline procedure for the preparation of a stable
eslicarbazepine acetate suspension using Aptiom tablets:
a. Prepare 30-mL suspending vehicle, that is, ORA-Plus
and purified water (50:50 v/v).
b. Crush the desired dose (1200 mg) of Aptiom tablets in
a mortar and pestle.
c. Add 10 mL of vehicle, that is, ORA-Plus:water (50:50
v/v), to a mortar and triturate until there are no visible
clumps.
d. Pour the mixture into a dispensing container/vial.
e. Rinse the mortar and pestle with a small amount of
vehicle (5-10 mL) and add to the dispensing container/
vial.
f. Make up the volume of the suspension in the dispensing cup by adding the remaining quantity of the vehicle.
g. To administer, pour suspension into oral syringe attached to the top of feeding tube and allow it to flow
through via gravity.
h. After administration of the suspension, flush the tubing with 15- to 30-mL purified water.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The author(s) disclosed receipt of the following financial support
for the research, authorship, and/or publication of this article:
The authors are grateful to SUNOVION Pharmaceuticals Inc.,
Marlborough, MA, for the financial support of the study.

References
1. Almeida L, Bialer M, Soares-da-Silva P. Eslicarbazepine acetate. In: The Treatment of Epilepsy. Wiley-Blackwell, Simon
Shorvon, Emilio Perucca, Jerome Engel, Jr. Oxford, UK:
ISBN: 978-1-118-93700-6. 2009:485-498.

Table of Contents for the Digital Edition of Hospital Pharmacy - December 2017