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Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting
S M D K Ganga Senarathna1, Tobias Strunk2, Michael Petrovski3
1Curtin Medical School, Curtin University, Bentley, WA, Australia.
Insights
Pentoxifylline (PTX) stability was assessed in simulated neonatal intensive care conditions. PTX injection at 5 mg/mL is stable for at least 7 days in common solutions, even when exposed to light.
Area of Science:
- Neonatal Pharmacology
- Pharmaceutical Stability
- Intensive Care Medicine
Background:
- Pentoxifylline (PTX) is used for neonatal sepsis and necrotizing enterocolitis via intravenous infusions.
- Limited formal stability data exists for PTX in its final clinical preparation.
- Neonatal intensive care units (NICUs) require reliable drug stability information for safe administration.
Purpose of the Study:
- To determine the stability of Pentoxifylline (PTX) injection at 5 mg/mL under simulated neonatal intensive care conditions.
- To provide evidence-based data on PTX stability in common intravenous solutions and varying environmental factors.
Main Methods:
- A stability-indicating high-performance liquid chromatography (HPLC) assay was developed and validated for PTX.
- PTX injection (5 mg/mL) in 0.9% sodium chloride or 5% glucose was stored in syringes at 4°C, 22°C, and 35°C, protected from light.
- Additional studies evaluated PTX stability at 22°C exposed to light, and under forced degradation conditions (alkali, acid, oxidation, heat).
Main Results:
- PTX injection (5 mg/mL) demonstrated stability in 0.9% sodium chloride and 5% glucose for at least 7 days when protected from light at 22°C and 35°C.
- Stability was maintained for at least 7 days at 22°C even when exposed to light.
- Forced degradation studies indicated PTX is stable at elevated temperatures (up to 45°C) and acidic conditions but degrades under alkaline and oxidative stress.
Conclusions:
- Pentoxifylline injection at 5 mg/mL is stable in 0.9% sodium chloride or 5% glucose for at least 7 days under typical NICU storage conditions (refrigerated, room temperature, incubator).
- The data supports the safe use of PTX injection in neonatal care, providing clinically relevant stability information for end-use preparations.
- Clinically relevant evidence confirms PTX injection stability in end-use, ICU/incubator conditions for at least 24 hours.
Abstract:
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.
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