Stability of floxuridine and leucovorin calcium admixtures for intraperitoneal administration Journal Article
| Authors: | Smith, J. A.; Morris, A.; Duafala, M. E.; Bertino, J. R.; Markman, M.; Kleinberg, M. L. |
| Article Title: | Stability of floxuridine and leucovorin calcium admixtures for intraperitoneal administration |
| Abstract: | The stability of floxuridine and leucovorin calcium in admixtures of 0.9% sodium chloride injection a various concentrations, temperature conditions, and time points was determined. Admixtures of floxuridine and leucovorin calcium were prepared in 1-L plastic bags containing 0.9% sodium chloride injection. Admixtures containing the following three concentrations were prepared: floxuridine 1 g and leucovorin calcium 30 mg, floxuridine 2 g and leucovorin calcium 240 mg, and floxuridine 4 g and leucovorin calcium 960 mg. The admixtures were stored at refrigerated temperature (4-8 °C), ambient room temperature (20 °C), and near-physiologic body temperature (40 °C). Drug concentrations were measured with a stability-indicating high-performance liquid chromatographic (HPLC) method at 0, 4, 8, 24, and 48 hours (4-8 °C) and at 0, 1, 3, 6, 24, and 48 hours (20 °C and 40 °C). A second set of samples at the same concentrations was prepared and sequentially stored at refrigerated, room, and near-physiologic temperatures to simulate actual-use conditions; these samples were assayed by HPLC at 0, 4, 8, 24, and 48 hours (4-8 °C); 49, 51, 54, and 60 hours (20 °C); and 61, 63, 66, and 72 hours (40 °C). All solutions were protected from light. Floxuridine and leucovorin calcium were stable at each concentration and temperature condition tested for a minimum of 48 hours. However, leucovorin calcium was more subject to decomposition at near-physiologic temperature than at other temperatures, with the most degradation at the lowest concentration. Under simulated actual-use conditions, floxuridine was stable without concentration-dependent trends, but leucovorin calcium, although retaining stability, showed a concentration-dependent decrease in potency over time, again with the highest degradation rate at the lowest concentration. Floxuridine and leucovorin calcium in admixtures containing 0.9% sodium chloride injection were stable at the tested concentrations. |
| Keywords: | nonhuman; methodology; temperature; chromatography, high pressure liquid; drug combinations; floxuridine; folinate calcium; leucovorin; drug stability; drug formulation; injections, intraperitoneal; drug storage; priority journal; support, non-u.s. gov't; preliminary communication |
| Journal Title: | American Journal of Hospital Pharmacy |
| Volume: | 46 |
| Issue: | 5 |
| ISSN: | 0002-9289 |
| Publisher: | Oxford University Press |
| Date Published: | 1989-05-01 |
| Start Page: | 985 |
| End Page: | 989 |
| Language: | English |
| PUBMED: | 2524968 |
| PROVIDER: | scopus |
| DOI: | 10.1093/ajhp/46.5.985 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 14 April 2020 -- Source: Scopus |
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