Stability of tramadol with three 5-HT3 receptor antagonists in polyolefin bags for patient-controlled delivery systems

Abstract

BackgroundMixing 5-hydroxytryptamine-3 (5-HT3) receptor antagonists with patient-controlled analgesia (PCA) solutions of tramadol has been shown to decrease the incidence of nausea and vomiting associated with the use of tramadol PCA for postoperative pain. However, such mixtures are not commercially available, and the stability of the drug combinations has not been duly studied. The study aimed to evaluate the stability of tramadol with three 5-HT3 receptor antagonists in 0.9% sodium chloride injection for PCA administration.Materials and methodsTest samples were prepared by adding 1,000 mg tramadol hydrochloride, 8 mg ondansetron hydrochloride, and 6 mg granisetron hydrochloride or 5 mg tropisetron hydrochloride to 100 mL of 0.9% sodium chloride injection in polyolefin bags. The samples were prepared in triplicates, stored at either 25°C or 4°C for 14 days, and assessed using the following compatibility parameters: precipitation, cloudiness, discoloration, and pH. Chemical stability was also determined using a validated high-pressure liquid chromatography method.ResultsAll of the mixtures were clear and colorless throughout the initial observation period. No change in the concentration of tramadol hydrochloride occurred with any of the 5-HT3 receptor antagonists during the 14 days. Similarly, little or no loss of the 5-HT3 receptor antagonists occurred over the 14-day period.ConclusionOur results suggest that mixtures of tramadol hydrochloride, ondansetron hydrochloride, granisetron hydrochloride, or tropisetron hydrochloride in 0.9% sodium chloride injection were physically and chemically stable for 14 days when stored in polyolefin bags at both 4°C and 25°C.

Simultaneous Determination of Dexamethasone, Ondansetron, Granisetron, Tropisetron, and Azasetron in Infusion Samples by HPLC with DAD Detection

“…On the basis of the literature consulted [11–31], an acidic aqueous medium and acetonitrile were selected to start the optimization of mobile phase composition. Trials showed that an acidic mobile phase with reverse phase C 18 column gives symmetric and sharp peaks.…”

“…From the literature survey it is evident that various analytical methods were available for the determination of DEX, OND, GRA, TRO, and AZA with other combinations by using high-performance liquid chromatography (HPLC) [11–31]. No method has been reported in the literature for simultaneous estimation of DEX, OND, GRA, TRO, and AZA in infusion samples.…”

Physical compatibility and chemical stability of dezocine and ramosetron in 0.9% sodium chloride injection for patient-controlled analgesia administration

“…Data arising from clinical reports have revealed that as an adjunct for dezocine PCA, ramosetron in combination with dezocine-based PCA for postoperative pain not only provides superior pain relief but also lowers the incidence of PONV. [10,17] However, no reports have been published regarding the physicochemical stability of the dezocine/ramosetron mixture. Therefore, this study aims to address this issue.…”

Desenvolvimento de um método indicativo de estabilidade para ondansetrona

“…Outros métodos por CLAE foram utilizados para monitoramento da estabilidade da ondansetrona em produtos farmacêuticos e em soluções mantidas em equipos médicos, como em solução de dextrose a 5% e cloreto de sódio injetáveis em seringas de polipropileno (CASTO, 1994;BURM, 1997) e em associação com outros IFA (STEWART et al, 1998;BOUGOUIN et al, 2001;WANG et al, 2016;FANG et al, 2016), incluindo a exposição das amostras a condições de estresse por temperatura, hidrólise ácida e alcalina. Em alguns trabalhos verificou-se queda no teor (CASTO, 1994;BURM, 1996;STEWART et al, 1998;FANG et al, 2016), porém a identidade ou concentração de possíveis compostos de degradação formados não foram determinadas.…”

“…De acordo com os trabalhos mencionados na literatura (CASTO, 1994;BURM, 1997;STEWART et al, 1998;BOUGOUIN et al, 2001;WANG et al, 2016;FANG et al, 2016)…”