Stability of refrigerated and frozen solutions of tropisetron in either polyvinylchloride or polyolefin infusion bags

Georget, S.; Vigneron, Jean; Blaise, N.; Perrin, A.; Hoffman, Mike

doi:10.1046/j.1365-2710.1997.9675096.x

Cited by 6 publications

(11 citation statements)

References 4 publications

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“…In both studies, tropisetron hydrochloride was stable for at least 14 days when stored at −20°C, 4°C, and 25°C. 23 , 24 However, in a study with fosaprepitant admixtures, tropisetron hydrochloride was found to be physically incompatible with fosaprepitant because of its alkaline pH value. 25 …”

Section: Discussionmentioning

confidence: 99%

Stability of Butorphanol–Tropisetron Mixtures in 0.9% Sodium Chloride Injection for Patient-Controlled Analgesia Use

et al. 2015

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Tropisetron is an adjuvant for butorphanol used in intravenous patient-controlled analgesia (PCA) and has been reported to provide superior pain control. It is efficacious in reducing the incidence of postoperative nausea and vomiting. However, this admixture is not available commercially and stability data applicable to hospital practice are limited. This study aimed to describe the drug compounding and evaluates the long-term (up to 14 days) stability of butorphanol and tropisetron in 0.9% sodium chloride injection for PCA use.In this study, commercial solutions of butorphanol tartrate and tropisetron hydrochloride were combined and further diluted with 0.9% sodium chloride injection to final concentrations of butorphanol tartrate 0.08 mg/mL and tropisetron hydrochloride 0.05 mg/mL. The polyolefin bags and glass bottles were stored at 4°C and 25°C for up to 14 days. The drug stabilities were determined by visual inspection, pH measurement, and high-pressure liquid chromatography assay of drug concentrations.The data obtained for admixtures prepared and stored at temperatures of 25°C and 4°C show the drugs have maintained at least 98% of the initial concentration. All solutions remained clear and colorless over the 14-day period, and the pH value did not change significantly.The results indicate that admixtures of butorphanol tartrate 0.08 mg/mL and tropisetron hydrochloride 0.05 mg/mL in 0.9% sodium chloride injection solution were stable for 14 days when stored in polyolefin bags or glass bottles at 4°C and 25°C and protected from light. The infusion is feasible for manufacturing in pharmacy aseptic units and can be stored for up to 14 days for routine use in PCA infusions.

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Section: Discussionmentioning

confidence: 99%

Stability of Butorphanol–Tropisetron Mixtures in 0.9% Sodium Chloride Injection for Patient-Controlled Analgesia Use

et al. 2015

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“…It is the case, 29 drugs described in 20 papers [15,24,[27][28][29][30]32,33,[42][43][44][45]47,52,[55][56][57]59,61,63,76]. The stability for a period of 24 hours at least was described for 17 drugs in 8 papers [22,[26][27][28][29]34,41,43,48].…”

Section: Discussionmentioning

confidence: 99%

Microwave freeze-thaw technique of injectable drugs. A review from 1980 to 2014

Hecq

Godet

Jamart

et al. 2015

Annales Pharmaceutiques Françaises

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“…The final nominal concentrations of dezocine and tropisetron hydrochloride were 0.4 mg/mL and 0.05 mg/mL, respectively. [17,18] The selection of the concentrations of these drugs in our study was based on those used in daily practice. Three polyolefin bags and 3 glass containers containing the dezocine and tropisetron hydrochloride admixture were stored at 4°C or 25°C.…”

Section: Methodsmentioning

confidence: 99%

Compatibility and stability of dezocine and tropisetron in 0.9% sodium chloride injection for patient-controlled analgesia administration

Chen

Zhou

2018

Medicine

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Tropisetron is an adjuvant for dezocine used in intravenous patient-controlled analgesia (PCA) and has been reported to provide superior pain control. It is efficacious in reducing the institutional incidence of postoperative nausea and vomiting (PONV), which decreases resource utilization and cost. However, no scientific evidence has been reported in the literature demonstrating analytical confirmation of the compatibility and stability of the combination of dezocine and tropisetron. Thus, the present study aimed to investigate the stability of dezocine with tropisetron in 0.9% sodium chloride injection form for PCA administration.Commercial solutions of dezocine and tropisetron were combined and examined for compatibility and stability when diluted with 0.9% sodium chloride injection in polyolefin bags and glass bottles stored at 4°C or 25°C for up to 14 days. The initial concentrations were 40 mg/100 mL dezocine and 5 mg/100 mL tropisetron. For all samples, the compatibility parameters (including precipitation, cloudiness, discoloration, and pH values) were evaluated. Chemical stability was also determined using high-performance liquid chromatographic (HPLC) analysis.After a 14-day period of storage at 4°C or 25°C, the initial concentrations of dezocine and tropisetron were maintained at at least 98%. All of the mixtures remained clear and colorless throughout the observation period, and no color change or precipitation was observed.These results indicated that admixtures of 40 mg/100 mL dezocine and 5 mg/100 mL tropisetron in 0.9% sodium chloride injection were stable for at least 14 days when stored in polyolefin bags or glass bottles at 4°C or 25°C and protected from light.

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Stability of refrigerated and frozen solutions of tropisetron in either polyvinylchloride or polyolefin infusion bags

Abstract: Tropisetron (50 microg/ml) in either 0.9% sodium chloride or 5% dextrose is chemically stable in polyvinylchloride or polyolefin bags for at least 3 months when stored in a refrigerator or in a frozen state.

Cited by 6 publications

References 4 publications

Stability of Butorphanol–Tropisetron Mixtures in 0.9% Sodium Chloride Injection for Patient-Controlled Analgesia Use

Stability of Butorphanol–Tropisetron Mixtures in 0.9% Sodium Chloride Injection for Patient-Controlled Analgesia Use

Microwave freeze-thaw technique of injectable drugs. A review from 1980 to 2014

Compatibility and stability of dezocine and tropisetron in 0.9% sodium chloride injection for patient-controlled analgesia administration

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