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- Title
Comparison of the stability and pharmacokinetics in dogs of modified ciclosporin capsules stored at −20°C and room temperature.
- Authors
Bachtel, Jeremy C.; Pendergraft, Jennifer S.; Rosychuk, Rodney A. W.; Gustafson, Daniel L.; Hansen, Ryan J.; Lunghofer, Paul J.
- Abstract
Background Placement of ciclosporin (Atopica®; Novartis Animal Health, Greensboro, NC, USA) capsules in a freezer prior to administration may reduce the incidence of vomiting in dogs. However, its impact on ciclosporin stability and pharmacokinetics is unknown. Hypothesis/Objectives The purpose of this study was to evaluate the stability of Atopica® capsules and pharmacokinetics of ciclosporin in dogs after storage at −20°C in comparison with storage of capsules at 15-25°C. We hypothesized that there would be no difference in stability or pharmacokinetic parameters between freezer-stored and room-temperature Atopica® capsules. Animals Eight healthy research beagle dogs received one 5.0 mg/kg oral dose each of freezer-stored and room-temperature Atopica® capsules with a 1 week washout period between. Methods Ciclosporin concentrations of all available Atopica® capsule strengths were assessed for stability after −20°C storage at five time points over 30 days and at room temperature (15-25°C). A blinded, randomized cross-over study was also performed to compare blood concentrations of ciclosporin after capsule storage for 28 days at −20 versus 15-25°C. Blood samples were obtained over a 24 h period after administration. Capsule and whole-blood ciclosporin concentrations were assessed via high-performance liquid chromatography-tandem mass spectrometry. Results There was no significant difference in stability between freezer-stored and room-temperature Atopica® capsules at any time point. In the cross-over study, there were no significant differences in pharmacokinetic parameters assessed. Conclusions and clinical importance Placing Atopica® capsules in a −20°C freezer for 28 days does not affect stability or absorption in the dog.
- Subjects
PHARMACOKINETICS; ABNORMALITIES in dogs; DRUG stability; CALCINEURIN; T cells
- Publication
Veterinary Dermatology, 2015, Vol 26, Issue 4, p228
- ISSN
0959-4493
- Publication type
Article
- DOI
10.1111/vde.12222