Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting
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...
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| Format: | Journal Article |
| Language: | English |
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ELSEVIER SCIENCE INC
2021
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| Online Access: | http://hdl.handle.net/20.500.11937/88950 |
| _version_ | 1848765122381611008 |
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| author | Senarathna, S.M.D.K.G. Strunk, T. Petrovski, M. Batty, Kevin |
| author_facet | Senarathna, S.M.D.K.G. Strunk, T. Petrovski, M. Batty, Kevin |
| author_sort | Senarathna, S.M.D.K.G. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T11:30:14Z |
| format | Journal Article |
| id | curtin-20.500.11937-88950 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T11:30:14Z |
| publishDate | 2021 |
| publisher | ELSEVIER SCIENCE INC |
| recordtype | eprints |
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| spelling | curtin-20.500.11937-889502022-08-05T07:22:27Z Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting Senarathna, S.M.D.K.G. Strunk, T. Petrovski, M. Batty, Kevin Science & Technology Life Sciences & Biomedicine Physical Sciences Chemistry, Medicinal Chemistry, Multidisciplinary Pharmacology & Pharmacy Chemistry Stability Intravenous drug HPLC Pentoxifylline Neonate DEGRADATION 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. 2021 Journal Article http://hdl.handle.net/20.500.11937/88950 10.1016/j.xphs.2021.08.035 English ELSEVIER SCIENCE INC restricted |
| spellingShingle | Science & Technology Life Sciences & Biomedicine Physical Sciences Chemistry, Medicinal Chemistry, Multidisciplinary Pharmacology & Pharmacy Chemistry Stability Intravenous drug HPLC Pentoxifylline Neonate DEGRADATION Senarathna, S.M.D.K.G. Strunk, T. Petrovski, M. Batty, Kevin Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting |
| title | Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting |
| title_full | Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting |
| title_fullStr | Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting |
| title_full_unstemmed | Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting |
| title_short | Stability of Pentoxifylline Injection: Application to Neonatal/Pediatric Care Setting |
| title_sort | stability of pentoxifylline injection: application to neonatal/pediatric care setting |
| topic | Science & Technology Life Sciences & Biomedicine Physical Sciences Chemistry, Medicinal Chemistry, Multidisciplinary Pharmacology & Pharmacy Chemistry Stability Intravenous drug HPLC Pentoxifylline Neonate DEGRADATION |
| url | http://hdl.handle.net/20.500.11937/88950 |