Stability of Lorazepam Oral Solution Stored in Syringes at Room and Refrigerated Temperatures
Location
Culp Center Ballroom
Start Date
4-25-2023 9:00 AM
End Date
4-25-2023 11:00 AM
Poster Number
108
Faculty Sponsor’s Department
Pharmaceutical Sciences
Name of Project's Faculty Sponsor
Stacy Brown
Additional Sponsors
Timothy Coffey
Competition Type
Competitive
Type
Poster Presentation
Project's Category
Chromatography
Abstract or Artist's Statement
The drug lorazepam is a benzodiazepine by class and is used in many healthcare settings as a sedative and anxiolytic. This drug is often found in hospital settings in the dosage form of an oral concentrate, of which patients may receive doses of 0.5 - 1 milliliters. A typical supply of drug product would come in a 30-milliliter bottle requiring protection from light, constant refrigeration, and a beyond use date of 90-days once the bottle is opened, according to package instructions. Aliquoting lorazepam oral solution into syringes allows for higher efficiency facilitated dispensing than as-needed dispensing from a multi-use stock bottle. Preparing individual doses in oral syringes before they are needed may also reduce dosing errors. There is currently no data that supports the practice of storing lorazepam oral solution in syringes, which introduces uncertainty of the product’s safety and efficacy over time. In this study, 2mg/mL lorazepam oral solution was aliquoted into syringes in 1mL doses from 2 multi-dose stock bottles and randomly allocated in an even proportion to be stored in either a room temperature or refrigerated environment. A validated stability-indicating high-performance liquid chromatography method with ultraviolet detection was used to investigate the concentration of lorazepam in the syringe-stored solutions. A fresh calibration curve in the range of 50 – 250 micrograms/mL lorazepam was prepared each day to facilitate quantification. Baseline lorazepam concentrations were measured on the day the study was initiated and designated as 100% recovery samples. Subsequent samples were analyzed from the refrigerated and room temperature syringes in triplicate at time points of 24, 48, and 96 hours and 7, 10, 14, 21, and 28 days. Our data predict that lorazepam can be safely stored in oral syringes at room and refrigerated temperatures for greater than 7 days.
Stability of Lorazepam Oral Solution Stored in Syringes at Room and Refrigerated Temperatures
Culp Center Ballroom
The drug lorazepam is a benzodiazepine by class and is used in many healthcare settings as a sedative and anxiolytic. This drug is often found in hospital settings in the dosage form of an oral concentrate, of which patients may receive doses of 0.5 - 1 milliliters. A typical supply of drug product would come in a 30-milliliter bottle requiring protection from light, constant refrigeration, and a beyond use date of 90-days once the bottle is opened, according to package instructions. Aliquoting lorazepam oral solution into syringes allows for higher efficiency facilitated dispensing than as-needed dispensing from a multi-use stock bottle. Preparing individual doses in oral syringes before they are needed may also reduce dosing errors. There is currently no data that supports the practice of storing lorazepam oral solution in syringes, which introduces uncertainty of the product’s safety and efficacy over time. In this study, 2mg/mL lorazepam oral solution was aliquoted into syringes in 1mL doses from 2 multi-dose stock bottles and randomly allocated in an even proportion to be stored in either a room temperature or refrigerated environment. A validated stability-indicating high-performance liquid chromatography method with ultraviolet detection was used to investigate the concentration of lorazepam in the syringe-stored solutions. A fresh calibration curve in the range of 50 – 250 micrograms/mL lorazepam was prepared each day to facilitate quantification. Baseline lorazepam concentrations were measured on the day the study was initiated and designated as 100% recovery samples. Subsequent samples were analyzed from the refrigerated and room temperature syringes in triplicate at time points of 24, 48, and 96 hours and 7, 10, 14, 21, and 28 days. Our data predict that lorazepam can be safely stored in oral syringes at room and refrigerated temperatures for greater than 7 days.