Stability of lamotrigine in two extemporaneously prepared oral suspensions at 4 and 25 degrees C.
The stability of lamotrigine 1 mg/mL in two extemporaneously prepared oral suspensions at 4 and 25 degrees C was studied. Lamotrigine tablets were ground to powder, and the powder was combined with a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus (Paddock Laboratories) to produce two 1-mg/mL suspensions. One 100-mg lamotrigine tablet was used to prepare one 100-mL batch of each suspension. The suspensions were stored in amber polyethylene terephthalate prescription bottles at 4 or 25 degrees C. Samples were collected on days 0, 7, 14, 28, 42, 56, 70, and 91 for analysis of lamotrigine content by high-performance liquid chromatography; pH was measured, and the samples were visually observed against a black and white background. The mean concentration of lamotrigine was >99% of the initial concentration in all samples throughout the 91-day study period; there was no change in apparent pH, odor, or physical appearance. Lamotrigine 1 mg/mL in two extemporaneously compounded oral suspensions was stable for 91 days in polyethylene terephthalate prescription bottles at 4 and 25 degrees C.
The Ohio State University, Wexner Institute for Pediatric Research, Children's Hospital, Columbus 43210, USA.
M C
MC
Nahata
R S
RS
Morosco
T F
TF
Hipple
D000284:Administration, Oral; D000927:Anticonvulsants / Q000008:administration & dosage / Q000737:chemistry*; D002648:Child; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D000077213:Lamotrigine; D013535:Suspensions; D013997:Time Factors; D014227:Triazines / Q000008:administration & dosage / Q000737:chemistry*
D000927:Anticonvulsants; D013535:Suspensions; D014227:Triazines; D000077213:Lamotrigine