Ketamina: estabilidade em seringas

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Development of ready-to-use ketamine hydrochloride syringes for safe use in post-operative pain

M Cyril Stucki, PharmD; Sandrine Fleury-Souverain, PhD; Anna-Maria Sautter, PhD; Farshid Sadeghipour, PhD; Pascal Bonnabry, PhD

ABSTRACT: Study objectives: To increase safety in use of ketamine. This would be achieved by introducing a ready-to-use (RTU) intravenous syringe of ketamine hydrochloride, which would be prepared under aseptic conditions in the hospital pharmacy, for post-operative pain.

Methods: The chemical stability of ketamine hydrochloride solution (1 mg/mL) in 0.9% sodium chloride was determined at 4°C, 25°C and 40°C by means of a stability-indicating capillary electrophoresis method. Changes in pH and the presence
of non-visible particulate matter were measured throughout the study. Sterility testing was performed to check the integrity of the syringes.

Results: The loss in potency was less than 8% after 12 months at the three temperatures, and no degradation products were detected. The pH values did not change appreciably and the syringe contents remained sterile throughout the study. Each syringe fulfilled all US Pharmacopeia criteria in terms of non-visible particles.

Conclusion: RTU syringes of ketamine hydrochloride with a shelf life of one year can be manufactured and supplied by the hospital pharmacy for use in post-operative pain. This product will help reduce the risk of dilution errors and lead to
significant economic advantages.

M Cyril Stucki, PharmD
Pharmacy Department
University Hospitals of Geneva
24 Rue Micheli du Crest
CH-1211 Geneva 14, Switzerland
Tel: +41 22 382 39 74
Fax: +41 22 382 39 40
cyril.stucki@hcuge.ch
www.hcuge.ch/Pharmacie

Reference: EJHP Science • Volume 14 • 2008 • Issue 1 • P. 14-18

Bupivacaína + sufentanila: estabilidade em seringas

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Chemical stability of a solution of bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL for filling syringes using a repeater pump.

Karin Janssen, PharmD; René Wisselo, B App Sci; Charles Geerlings, PharmD; Jan Pieter Schouten, PharmD, MBM

ABSTRACT: Study objective: In Sint Franciscus Gasthuis, Rotterdam, The Netherlands, syringes filled with bupivacaine hydrochloride 0.125% and sufentanil citrate 0.5 μg/mL are administered epidurally during post-operative analgesia. These syringes are filled in the pharmacy using a Baxa Repeater pump. The suitability of the filling method and the shelf-life of the solution in the syringes were investigated.

Methods: During the filling process six samples were taken. Three syringes were stored at room temperature and three in the refrigerator. Samples were taken on days 4, 7, 14 and 28. High performance liquid chromatographic (HPLC) methods were used to measure the concentrations of both drugs in the samples.

Results: No loss of drugs was observed during the filling process. After 28 days at room temperature and in the refrigerator, the concentration of bupivacaine hydrochloride was 97.4 ± 0.9% and 97.9 ± 1.0% respectively, and that of sufentanil
citrate was 95.6 ± 4.2% and 99.2 ± 1.4%.

Conclusion: The filling method used with a Baxa Repeater pump is acceptable. Bupivacaine/sufentanil solution in syringes is chemically stable for at least 28 days in the refrigerator.

Contact: Karin Janssen, PharmD
Apotheek Zuwe Hofpoort Ziekenhuis
2 Polanerbaan
3447 GN Woerden, The Netherlands
Tel: +31 348 427385
Fax: +31 348 427489
kjanssen@zuwe.nl

Reference: EJHP Science • Volume 15 • 2009 • Issue 1 • P. 11-14