Project Title

Stability of Oral Vitamin K Solutions Stored in Amber Plastic Syringes

Authors' Affiliations

Sarah Lawson, BS, PharmD Candidate, and Dr. Stacy Brown, PhD, Associate Professor, Department of Pharmaceutical Sciences, Bill Gatton College of Pharmacy, East Tennessee State University; Maple Avenue, Bldg. 7 PO Box 70414 Johnson City, TN 37614

Location

Ballroom

Start Date

4-5-2018 8:00 AM

End Date

4-5-2018 12:00 PM

Poster Number

98

Name of Project's Faculty Sponsor

Stacy Brown

Faculty Sponsor's Department

Pharmaceutical Sciences

Type

Poster: Competitive

Classification of First Author

Pharmacy Student

Project's Category

Biomedical and Health Sciences

Abstract Text

Oral vitamin K is administered to patients who have very high INR lab values and are on warfarin therapy. Due to the inability of some patients to swallow tablets, and the commercial formulation of vitamin K being available only as a tablet or an injectable emulsion, it may be necessary to compound an oral liquid formulation. When compounding batches of oral solutions, it is sometimes convenient to measure the product in unit doses. In this project, we compared liquid vitamin K in sterile water (1mg/mL) verses liquid vitamin K in Ora-Sweet (1mg/mL) stored in amber plastic syringes. Vitamin K is light sensitive and is best stored in amber containers. Vitamin K is also lipophilic and may adsorb to the plastic syringes. In this study, we investigated the feasibility of bulk compounding oral vitamin K solutions, and aliquoting them for storage in amber plastic syringes. The Vitamin K in sterile water syringes were made by mixing 45 mL of sterile water and 5 ampules, each containing 10mg/mL of vitamin K emulsion, together in an amber glass bottle for a final concentration of 1mg/mL. Thirty 1mL plastic amber syringes were filled with the mixture, capped, and placed in the refrigerator. The same process was repeated using Ora-Sweet instead of sterile water to fill thirty more plastic amber syringes. Three syringes of vitamin K in sterile water mixture, three syringes of vitamin K in Ora-Sweet mixture, and one Vitamin K reference standard were all analyzed using HPLC-UV on the day of compounding, and at day 1, 2, 4, 7, 14, 21, 30, 60, and 90. If stability is defined as 90-110% active ingredient, then Vitamin K in sterile water is stable to fourteen days, 95.3±3.5% recovery, but some samples fell below 90% recovery after 14 days. By day ninety, the recovery in SWFI syringes was 84.2±8.9%. For vitamin K in Ora-Sweet, the within-day variability was very high due to limitations in drug dissolution; as such the average concentration was not consistently above 90%. On the day of compounding, the percent recovery in the Ora-Sweet syringes was 92.7±9.9%, despite 1 hour of stirring. In conclusion, the Vitamin K in sterile water mixture can be stored in refrigerated, amber oral plastic syringes for 14 days, but plastic amber syringes were not appropriate for storage of the Vitamin K in Ora-Sweet mixture.

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Apr 5th, 8:00 AM Apr 5th, 12:00 PM

Stability of Oral Vitamin K Solutions Stored in Amber Plastic Syringes

Ballroom

Oral vitamin K is administered to patients who have very high INR lab values and are on warfarin therapy. Due to the inability of some patients to swallow tablets, and the commercial formulation of vitamin K being available only as a tablet or an injectable emulsion, it may be necessary to compound an oral liquid formulation. When compounding batches of oral solutions, it is sometimes convenient to measure the product in unit doses. In this project, we compared liquid vitamin K in sterile water (1mg/mL) verses liquid vitamin K in Ora-Sweet (1mg/mL) stored in amber plastic syringes. Vitamin K is light sensitive and is best stored in amber containers. Vitamin K is also lipophilic and may adsorb to the plastic syringes. In this study, we investigated the feasibility of bulk compounding oral vitamin K solutions, and aliquoting them for storage in amber plastic syringes. The Vitamin K in sterile water syringes were made by mixing 45 mL of sterile water and 5 ampules, each containing 10mg/mL of vitamin K emulsion, together in an amber glass bottle for a final concentration of 1mg/mL. Thirty 1mL plastic amber syringes were filled with the mixture, capped, and placed in the refrigerator. The same process was repeated using Ora-Sweet instead of sterile water to fill thirty more plastic amber syringes. Three syringes of vitamin K in sterile water mixture, three syringes of vitamin K in Ora-Sweet mixture, and one Vitamin K reference standard were all analyzed using HPLC-UV on the day of compounding, and at day 1, 2, 4, 7, 14, 21, 30, 60, and 90. If stability is defined as 90-110% active ingredient, then Vitamin K in sterile water is stable to fourteen days, 95.3±3.5% recovery, but some samples fell below 90% recovery after 14 days. By day ninety, the recovery in SWFI syringes was 84.2±8.9%. For vitamin K in Ora-Sweet, the within-day variability was very high due to limitations in drug dissolution; as such the average concentration was not consistently above 90%. On the day of compounding, the percent recovery in the Ora-Sweet syringes was 92.7±9.9%, despite 1 hour of stirring. In conclusion, the Vitamin K in sterile water mixture can be stored in refrigerated, amber oral plastic syringes for 14 days, but plastic amber syringes were not appropriate for storage of the Vitamin K in Ora-Sweet mixture.