title: A Pilot Chemical and Physical Stability Study of Extemporaneously Compounded Levetiracetam Intravenous Solution.
abstract: Levetiracetam is a commonly used antiepileptic medication for tumor-related epilepsy. However, the 100 mL intravenous (IV) infusion volume can be burdensome to imminently dying hospice patients. A reduced infusion volume would improve patient tolerability. The purpose of this study was to evaluate the stability of 1000 mg/25 mL (40 mg/mL) levetiracetam IV solution in sodium chloride 0.9%. We prepared levetiracetam 40 mg/mL IV solution and added it to polyvinyl chloride (PVC) bags, polyolefin bags, and polypropylene syringes. Triplicate samples of each product were stored at refrigeration (2-8°C) and analyzed on days 0, 1, 4, 7, and 14. Samples were subjected to visual inspection, pH measurement, and stability-indicating high-performance liquid chromatography (HPLC) analysis. Over the 2-week storage period, there was no significant change in visual appearance or pH for any of the stability samples. The HPLC results confirmed that all stability samples retained 94.2-101.3% of initial drug concentration and no degradation products or leachable material from the packaging materials were observed. We conclude that levetiracetam 1000 mg/25 mL IV solution in sodium chloride 0.9% is physically and chemically stable for up to 14 days under refrigeration in polypropylene syringes, PVC bags, and polyolefin bags.
authors.forename: Chenzira D
authors.initials: CD
authors.lastname: Raphael
authors.forename: Fang
authors.initials: F
authors.lastname: Zhao
authors.forename: Susan E
authors.initials: SE
authors.lastname: Hughes
authors.forename: Katherine M
authors.initials: KM
authors.lastname: Juba
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous; D000077287:Levetiracetam; D019999:Pharmaceutical Solutions / Q000737:chemistry*; D010865:Pilot Projects; D010889:Piracetam / Q000031:analogs & derivatives* / Q000737:chemistry; D011090:Polyenes / Q000737:chemistry; D011126:Polypropylenes / Q000737:chemistry; D011143:Polyvinyl Chloride / Q000737:chemistry; D013594:Syringes
chemical_list: D019999:Pharmaceutical Solutions; D011090:Polyenes; D011126:Polypropylenes; D000077287:Levetiracetam; C035051:PL 732; D011143:Polyvinyl Chloride; D010889:Piracetam
keywords: concentrated; epilepsy; intravenous; levetiracetam; neuropathic; pain; seizures; stability