Am J Health Syst Pharm. 2016
Sep 1;73(17):1331-7. doi: 10.2146/ajhp150581.
Abstract
PURPOSE:
The stability of extemporaneously prepared erlotinib, lapatinib, and
imatinib oral liquid dosage forms using two commercially available vehicles
when stored at 4 and 25 °C was evaluated.
METHODS:
Three batches of extemporaneous oral suspensions were prepared for each
drug. Erlotinib and lapatinib tablets were crushed and mixed in a 1:1 mixture
of Ora-Plus:Ora-Sweet solution to yield 10- and 50-mg/mL suspensions,
respectively. Imatinib tablets were crushed and mixed in Ora-Sweet solution to
yield a 40-mg/mL suspension. Suspensions were stored in amber plastic bottles,
and samples from each bottle were obtained on days 0, 1, 3, 7, 14, and 28.
RESULTS:
Erlotinib 10-mg/mL and lapatinib 50-mg/mL oral suspensions in a 1:1
mixture of Ora-Plus and Ora-Sweet retained at least 90% of their initial
concentration throughout the 28-day study when stored at 25 °C. Visual
inspection revealed notable viscosity changes in the erlotinib and lapatinib
suspensions stored at 4 °C for 7 days and beyond. The viscosity of these
preparations increased with time and was particularly evident with the
erlotinib suspension, which exhibited a puddinglike texture. Imatinib 40-mg/mL
oral suspension in Ora-Sweet appeared stable for up to 14 days when stored at
both 25 and 4 °C.
CONCLUSION:
Erlotinib 10-mg/mL and lapatinib 50-mg/mL oral suspensions prepared from
commercially available tablets were stable for at least 28 days when prepared
in a 1:1 mixture of Ora-Plus:Ora-Sweet at 25 °C. Imatinib 40-mg/mL oral
suspension prepared from commercially available tablets was stable for up to 14
days when prepared in Ora-Sweet and stored at 25 and 4 °C.
Copyright © 2016 by the American Society of Health-System Pharmacists,
Inc. All rights reserved.
