Stability of fentanyl 5 μg/mL diluted with 0.9% sodium chloride injection and stored in polypropylene syringes

McCluskey, Susan V; Graner, Kevin K.; Kemp, Jesse; Aloumanis, Vasileios; Ben, Michel; Kupiec, Thomas C.; Vu, Nicole

doi:10.2146/ajhp080255

Cited by 14 publications

(13 citation statements)

References 2 publications

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“…Some important formulation considerations for clinical usage are drug concentration [28], ease of administration [29], and formulation stability during storage [30, 31]. Many formulations made from liposomes or polymer-based systems exist as colloidal liquids, which are generally stable for short periods of time [32].…”

Section: Introductionmentioning

confidence: 99%

Reconstitutable charged polymeric (PLGA)2-b-PEI micelles for gene therapeutics delivery

Mishra¹,

Kang²,

Bae³

2011

Biomaterials

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This study investigated the potential of creating a charged polymeric micelle-based nucleic acid delivery system that could easily be reconstituted by the addition of water. (PLGA 36kDa ) 2 -bbPEI 25kDa (PLGA MW 36kDa, bPEI M w 25kDa, PLGA:bPEI block ratio = 2) was synthesized and used to prepare cationic micelles. The copolymer retained proton-buffering capability from the bPEI block within the endosomal pH range. Micelle/pDNA complexes retained their particle size (100-150 nm) and surface charge (30-40 mV) following reconstitution. It was found that adding a small amount of low molecular weight bPEI (1.8 kDa) completely shielded pDNA in the micelle/pDNA complexes and enhanced transfection efficiency 50-100 fold for both fresh and reconstituted complexes without affecting complex size. Transfection efficiency for "reconstituted" micelle/pDNA/bPEI 1.8kDa (WR 1) complexes was 16-fold higher than its "fresh" counterpart. Although transfection levels achieved using "reconstituted" micelle/pDNA/ bPEI 1.8kDa complexes were 3.6-fold lower than control "fresh" bPEI 25kDa /pDNA (N/P 5) complexes, transfection levels were 39-fold higher than "reconstituted" bPEI 25kDa /pDNA (N/P 5) complexes. The micelle/pDNA/bPEI 1.8kDa system showed very low cytotoxicity in MCF7 cells even with pDNA doses up to 20 μg, and transfection levels increased linearly with increasing pDNA dose. These results indicate that this PLGA-b-bPEI polymeric micelle-based system is well suited as a reconstitutable gene delivery system, and has high potential for use as a delivery system for gene therapy applications.

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Section: Introductionmentioning

confidence: 99%

Reconstitutable charged polymeric (PLGA)2-b-PEI micelles for gene therapeutics delivery

Mishra¹,

Kang²,

Bae³

2011

Biomaterials

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“…Studies have demonstrated that fentanyl sterile solution packaged in medical and hospital devices, such as polypropylene syringes, polyvinylchloride bags and patient-controlled delivery systems requires especial precautions for maintaining drug stability, depending on the packaging material, temperature, storage life and duration of drug administration (DONNELLY, 2005; CHAPALAIN-PARGADE et al, 2006;MCCLUSKEY et al, 2009). …”

Section: Resultsmentioning

confidence: 99%

Determination of Fentanyl in Injection Solution Exposed to Improper Storage Conditions

Lombardo

Eserian

2018

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RESUMOA estabilidade de medicamentos consiste no potencial do produto em preservar as especificações de qualidade em toda a cadeia de suprimento. Embora esforços devam ser realizados para aprimorar a estabilidade da formulação, algumas precauções podem ser requeridas para minimizar fatores externos que afetem características físico-químicas determinantes da eficácia e segurança do produto. Neste trabalho, uma solução injetável de citrato de fentanila foi submetida a diferentes esquemas de fotoexposição a curto prazo, a fim de simular possíveis desvios no manuseio e armazenamento do produto durante a rotina hospitalar. O teor do fármaco foi avaliado por cromatografia líquida de alta eficiência em fase reversa (CLAE-FR), utilizando um detector de fotodiodos. Os resultados indicaram que o teor de fentanila foi satisfatório, mesmo após a exposição das ampolas à luz solar ou à luz artificial por 18 horas. Estudos futuros se fazem necessários para avaliar o efeito de condições ambientais adversas sobre a solução injetável de fentanila.Palavras-chave: Fentanila; Estabilidade de Medicamentos; Armazenamento de Medicamentos. 2 ABSTRACTStability of drugs consists of the product`s potential to preserve the quality specifications within the entire supply chain. Although efforts should be taken to improve the formulation stability, some precautions may be required to minimize external factors affecting physicochemical characteristics that determine product's effectiveness and safety. In this work, fentanyl citrate injection solution has been subjected to different schemes of short-term photoexposure, in order to simulate possible deviations in the handling and storage of the product during the hospital routine. Drug potency was evaluated by reversed-phase highperformance liquid chromatography (RP-HPLC), using a photodiode array detector. The results indicated that the amount of fentanyl was satisfactory even after the exposure of the ampoules to sunlight or artificial light for 18 hours. Further studies are needed to evaluate the effect of adverse environmental conditions on fentanyl injection.

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“…Entretanto, outros fatores devem ser averiguados, como as condições pontuais de armazenamento e uso. Alguns estudos demonstram que soluções de fentanila acondicionadas em seringas, bolsas e sistemas de analgesia controlada pelo paciente requerem precauções especiais a fim de manter a estabilidade do fármaco (11)(12)(13).…”

Section: Figura 2 -Curva De Calibração Do Citrato De Fentanilaunclassified

Investigação Da Suspeita De Desvio De Qualidade Em Uma Solução Injetável De Citrato De Fentanila

Lombardo

Eserian

2015

Infarma

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Investigação da suspeita de desvio de qualidade em uma solução injetável de citrato de fentanilaInvestigation of a quality deviation occurrence on a fentanyl citrate solution for injection ABSTRACT Fentanyl is a pain reliever drug for hospital use mainly indicated as an anesthesia adjunct. Due to a complaint made by a hospital located in São Paulo, related to therapeutic failure of an injectable solution containing fentanyl citrate after use in anesthesia, samples of the product were collected for analysis by health services. The objective of this study was to perform physico-chemical tests on the samples, with priority to quantification and drug identification, using a high performance liquid chromatograph couppled with diode array detector. The two batches analyzed showed positive identification of fentanyl citrate and 97.30% of the drug content; these results were in accordance to recommended range by the product manufacturer. Thus, it was possible to exclude deviations in the drug content as the cause for therapeutic inefficacy, indicating the need for additional investigation and raising further discussion of the case.Keywords: Analysis of Products; Fentanyl; Chromatography, Liquid; Dosage RESUMO A fentanila é um fármaco analgésico de uso hospitalar indicado principalmente como componente da anestesia. Devido a uma queixa técnica de um hospital de São Paulo apontando a ineficácia terapêutica de uma solução injetável de citrato de fentanila após o uso na anestesia, amostras do produto foram coletadas pela Vigilância Sanitária para análise. O objetivo deste trabalho foi realizar ensaios físico-químicos nas amostras, com prioridade para identificação e teor do fármaco, utilizando um cromatógrafo líquido de alta eficiência equipado com detector de arranjo de diodos. Os dois lotes analisados apresentaram identificação positiva para citrato de fentanila e 97,30% do teor declarado do fármaco; resultados satisfatórios em relação ao especificado pelo fabricante do produto. Assim, foi possível excluir desvios no teor do fármaco como a causa da ineficácia terapêutica, indicando a necessidade de investigações complementares e levantando maiores discussões sobre o caso.

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Stability of fentanyl 5 μg/mL diluted with 0.9% sodium chloride injection and stored in polypropylene syringes

Abstract: Fentanyl 5 microg (as the citrate) per milliliter in 0.9% sodium chloride injection, packaged in polypropylene syringes and stored protected from light, was stable for at least 90 days in controlled ambient conditions.

Cited by 14 publications

References 2 publications

Reconstitutable charged polymeric (PLGA)2-b-PEI micelles for gene therapeutics delivery

Reconstitutable charged polymeric (PLGA)2-b-PEI micelles for gene therapeutics delivery

Determination of Fentanyl in Injection Solution Exposed to Improper Storage Conditions

Investigação Da Suspeita De Desvio De Qualidade Em Uma Solução Injetável De Citrato De Fentanila

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