Stability of Lorazepam Oral Solution Stored in Syringes at Room and Refrigerated Temperatures

Authors' Affiliations

Samantha Morris, Department of Pharmaceutical Science, Gatton College of Pharmacy, East Tennessee State University, Johnson City, TN. Sophia Sergent, Department of Pharmaceutical Science, Gatton College of Pharmacy, East Tennessee State University, Johnson City, TN. Michelle Tubolino, Department of Pharmaceutical Science, Gatton College of Pharmacy, East Tennessee State University, Johnson City, TN. Timothy Coffey, Regulatory Affairs at Ballad Health, Ballad Health, Johnson City, TN. Stacy Brown, Department of Pharmaceutical Science, Gatton College of Pharmacy, East Tennessee State University, Johnson City, TN.

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

Classification of First Author

Pharmacy Student

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.

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Apr 25th, 9:00 AM Apr 25th, 11:00 AM

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.