title: Stability of extemporaneous erlotinib, lapatinib, and imatinib oral suspensions.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacy, James Comprehensive Cancer Hospital and Richard Solove Research Institute, Ohio State University Wexner Medical Center, Columbus, OH.
authors.forename: Quan
authors.initials: Q
authors.lastname: Li
authors.affiliation: College of Veterinary Medicine, Hunan Agricultural University, Hunan, China.
authors.forename: Zhaoying
authors.initials: Z
authors.lastname: Liu
authors.affiliation: College of Pharmacy, Ohio State University, Columbus, OH.
authors.forename: Shamalatha
authors.initials: S
authors.lastname: Kolli
authors.affiliation: Department of Pharmacy, Ohio State University Wexner Medical Center, Columbus, OH.
authors.forename: Karen
authors.initials: K
authors.lastname: Wetz
authors.affiliation: Department of Pharmacy, James Comprehensive Cancer Hospital and Richard Solove Research Institute, Ohio State University Wexner Medical Center, Columbus, OH.
authors.forename: Niesha
authors.initials: N
authors.lastname: Griffith
authors.affiliation: Division of Pharmacy Practice and Science, College of Pharmacy, Ohio State University, Columbus, OHDepartment of Pharmacy, James Comprehensive Cancer Hospital and Richard Solove Research Institute, Ohio State University Wexner Medical Center, Columbus, OH. poi.2@osu.edu.
authors.forename: Ming J
authors.initials: MJ
authors.lastname: Poi
mesh_terms: D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical / Q000379:methods* / Q000592:standards; D004304:Dosage Forms; D004355:Drug Stability; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D006801:Humans; D000068877:Imatinib Mesylate / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D000077341:Lapatinib; D011799:Quinazolines / Q000008:administration & dosage / Q000737:chemistry* / Q000592:standards; D013535:Suspensions
chemical_list: D004304:Dosage Forms; D011799:Quinazolines; D013535:Suspensions; D000077341:Lapatinib; D000068877:Imatinib Mesylate; D000069347:Erlotinib Hydrochloride