Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting
| Autor: | Michael Petrovski, Kevin T. Batty, Tobias Strunk, S M D K Ganga Senarathna |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Sodium
Drug Storage Pharmaceutical Science chemistry.chemical_element High-performance liquid chromatography Pentoxifylline Injections Sepsis Drug Stability Intensive care medicine Humans Child Infusions Intravenous Chromatography High Pressure Liquid Syringe driver Chromatography Chemistry Syringes Infant Newborn Temperature medicine.disease Forced degradation Necrotizing enterocolitis medicine.drug |
| Zdroj: | Journal of pharmaceutical sciences. 110(12) |
| ISSN: | 1520-6017 |
| Popis: | Pentoxifylline (PTX) is administered as 6- or 12-hour intravenous infusions in the treatment of sepsis or necrotizing enterocolitis in neonates; however, there is a paucity of formal stability data for PTX in the end-use solution. We investigated PTX stability in the simulated clinical conditions of neonatal intensive care, where PTX injection is diluted to 5 mg/mL and administered via syringe pump. A stability-indicating high performance liquid chromatography (HPLC) assay was established for PTX. The clinical simulation stability study comprised PTX 5 mg/mL in 20 mL syringes and was conducted at three temperatures, all protected from light: refrigerator (4°C); room temperature (22°C) and incubator/humidicrib (35°C). PTX stability also was evaluated at room temperature and exposed to light. Samples were drawn at pre-determined times over a 10 day period and stored frozen (-80°C) until assayed by HPLC. A single exponential equation was fitted to the concentration-time data to determine PTX stability. Forced degradation studies confirmed that PTX was stable at elevated temperature (up to 45°C), exposed to light and under acidic stress for up to 10 days, but subject to degradation under alkali and oxidative stress. PTX injection 5 mg/mL in 0.9% w/v sodium chloride or 5% w/v glucose was found to be stable when protected from light at 22°C and 35°C, and exposed to light at 22°C for at least 7 days. These data provide clinically relevant evidence that PTX injection is stable in the end-use, ICU/incubator clinical conditions for at least 24 hours. |
| Databáze: | OpenAIRE |
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