Stability of extemporaneous erlotinib, lapatinib, and imatinib oral suspensions

作者:Li, Quan; Liu, Zhaoying; Kolli, Shamalatha; Wetz, Karen; Griffith, Niesha; Poi, Ming J.*
来源:American Journal of Health-System Pharmacy, 2016, 73(17): 1331-1337.
DOI:10.2146/ajhp150581

摘要

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 degrees 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 degrees C. Visual inspection revealed notable viscosity changes in the erlotinib and lapatinib suspensions stored at 4 degrees 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 degrees 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 degrees 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 degrees C.