Release of silicone oil and the off-label use of syringes in ophthalmology.

BACKGROUND/AIMS: To assess silicone oil (SO) release by different brands of syringes used for intravitreal injection under different handling conditions. METHODS: Eight syringes were analysed: from the USA, Terumo 0.5 mL, Becton-Dickinson (BD) Tuberculin 1 mL, BD Luer-lok 1 mL, BD Ultra-Fine 0.3 mL and Exel Insulin 0.3 mL; from Germany, Braun Omnifix-F 1 mL and Braun Injekt-F 1 mL and from Spain, BD Plastipak 1 mL. The impact of air, priming the plunger, agitation by flicking and fluid temperature on SO release were assessed by light microscopy. Fourier transform infrared spectroscopy (FTIR) was performed to identify the molecular compound in each syringe. RESULTS: Five hundred and sixty syringes were analysed. Terumo 0.5 mL and BD Ultra-Fine 0.3 mL released more SO than all others. BD Luer-lok 1 mL, BD Plastipak and Braun Omnifix-F 1 mL released little SO; BD Tuberculin 1 mL, Exel 0.3 mL and Braun Injekt-F 1 mL released the least SO. Priming the syringe and different temperatures did not significantly affect SO release. Agitation by flicking caused a significantly higher proportion of samples to have SO droplets and an increased number of oil droplets. Air had an additive effect on the release of oil in the agitation groups. FTIR identified polysiloxane in all syringes but Injekt-F. CONCLUSION: Syringes commonly used for intravitreal injections frequently release SO droplets, especially when agitated by flicking. To avoid unnecessary ocular risks, syringes should not be agitated before intravitreal injection. It is desirable that syringes be manufactured specifically for ophthalmic use.

Unmet Quality Needs in Oral Drug Delivery: Contrasts of Drug Content and Uniformity on Distinct Approaches for Achieving Individual Dosing.

Individualized dosing is often required in pharmacotherapy, particularly for pediatric and geriatric patients and adjustment of drugs that demand dose adaptation. This study aimed to evaluate critical quality attributes (CQAs) of doses obtained by distinct approaches for achieving individual dosing. Approaches were evaluated as follows: subdivision of tablets by splitter and hand (haloperidol) and delivery by plastic dropper bottle (haloperidol), glass dropper bottle (clonazepam), dosing cup (sodium valproate), and dosing syringe (carbamazepine), including brand name, generic, and similar marketed products. Measuring devices were packaged with their respective product. Drug content uniformity was assessed to each substance according to pharmacopeial methods. Tablets subdivided by splitter had the poorest performance among all approaches, in which doses ranged around 60% of the labeled amount (Acceptance Value = 58.1 and RSD = 23.2%). The greatest performances were observed for the dosing syringe which fulfilled all the requirements for dose precision and for the glass dropper bottle. There were significant differences in dose delivery between manufacturers of the same medicine when measuring the same volume or number of drops. High drug content variability is extremely harmful to pharmacotherapy and may result in therapeutic failure or toxicity. It is crucial that measuring devices and scoring of tablets be checked for functionality and standardized for different manufacturers of the same medicine. Part of the approaches for achieving individual dosing did not meet the quality needs for drug content and uniformity. Yet, our findings show that more accurate and precise dosing can be accessed when using the dosing syringe and glass dropper bottle.

Nonlinear Flow Sensor Calibration with an Accurate Syringe.

Flow sensors are required for monitoring patients on mechanical ventilation and in respiratory research. Proper calibration is important for ensuring accuracy and can be done with a precision syringe. This procedure, however, becomes complex for nonlinear flow sensors, which are commonly used. The objective of the present work was to develop an algorithm to allow the calibration of nonlinear flow sensors using an accurate syringe. We first noticed that a power law equation could properly fit the pressure-flow relationship of nonlinear flow sensors. We then developed a software code to estimate the parameters for this equation using a 3 L syringe (calibration syringe). Finally, we tested the performance of a calibrated flow sensor using a different 3 L syringe (testing syringe) and a commercially available spirometer. After calibration, the sensor had a bias ranging from −1.7% to 3.0% and precision from 0.012 L to 0.039 L for volumes measured with the 3 L testing syringe. Calibrated sensor performance was at least as good as the commercial sensor. This calibration procedure can be done at the bedside for both clinical and research purposes, therefore improving the accuracy of nonlinear flow sensors.

A Comparison of Protein Stability in Prefillable Syringes Made of Glass and Plastic.

The development of protein therapeutics requires stabilization of these labile molecules during shipment and storage. Biologics, particularly monoclonal antibodies, are frequently packaged at high concentration in prefillable syringes traditionally made of glass. However, some biologics are unstable in glass due to sensitivity to silicone oil, tungsten, glue, or metal ions. Syringes made from the plastic cyclic olefin polymer, Daikyo Crystal Zenith® (CZ), with a Flurotec-laminated piston, have none of these issues. This study compared the stability of several proteins including biotherapeutics when stored up to 14 months at 5 °C and 25 °C in prefillable siliconized syringes made of glass or silicone oil-free CZ syringes, and when subjected to mild agitation by end-over-end rotation at room temperature. At each time point, proteins were analyzed by several techniques including turbidity, size exclusion high-performance liquid chromatography, reversed phase high-performance liquid chromatography, ion-exchange chromatography, electrophoresis, and light scattering to monitor changes in aggregation and degradation. The results show that proteins have comparable stability when stored in glass syringes or in syringes made of CZ sterilized by E-beam or autoclave. In addition, proteins stressed by agitation were generally more stable and aggregated less in syringes made of CZ than in ones made of glass.LAY ABSTRACT: Biotherapeutic protein drugs such as monoclonal antibodies are frequently packaged at high concentration in prefillable syringes, which allows the drug to be directly administered by the patient or caregiver. Protein drugs, or biologics, can be unstable, and may aggregate, particularly when shaken. These aggregates can be immunogenic, stimulating the body's immune system to produce antibodies that can reduce the drug's efficacy. Although prefillable syringes are traditionally made of glass, some biologics are unstable in glass syringes due to the presence of substances used in their manufacture, including silicone oil, which is necessary for lubricity. Syringes made from the plastic cyclic olefin polymer, Daikyo Crystal Zenith® (CZ), have none of these issues. This study compared the stability of several biotherapeutic proteins when stored up to 14 months at 5 °C and 25 °C in prefillable siliconized syringes made of glass or silicone oil-free CZ syringes, and when mildly agitated at room temperature. Proteins were analyzed by several techniques to detect changes in aggregation and degradation. The results show that biotherapeutic proteins have similar stability whether stored in syringes made of glass or CZ. In addition, proteins subjected to agitation were generally more stable and aggregated less in CZ syringes than in glass syringes.

Multimídia interativa como recurso para utilização de materiais perfurocortantes com dispositivo de segurança na punção venosa periférica / Interactive multimedia as a resource for the use of sharps with safety device in peripheral venipuncture

Em função da inserção das Novas Tecnologias da Informação e Comunicação, na prática da Enfermagem, notamos que esta pode ser uma importante ferramenta de aprendizado, podendo contribuir para uma atuação da Equipe de Enfermagem mais eficaz. Logo, o Objeto de Estudo da presente pesquisa foi a multimídia interativa com vistas à adequada utilização de materiais perfurocortantes com dispositivo de segurança durante a punção venosa periférica. O objetivo central foi desenvolver uma multimídia interativa com vistas à adequada utilização de materiais perfurocortantes com dispositivo de segurança. Metodologia: o método adotado foi o quanti-qualitativo, sendo um estudo do tipo observacional. Resultados: 1- No que se refere ao momento da punção venosa periférica, notamos que embora a recomendação para higienização das mãos seja mandatória e que esta deve anteceder qualquer procedimento a ser realizado, apenas 20% dos participantes o fizeram antes da punção venosa periférica e; 2 - Na última etapa do procedimento realizado, o dado que nos chama atenção é que 80% dos participantes não realizaram o cálculo para a infusão dos medicamentos, realizando a infusão inicial de forma aleatória. Conclusão: Foi identificada a necessidade de uma nova abordagem específica referente ao treinamento de perfurocortantes com dispositivo de segurança, uma vez que com o desenvolvimento da nossa multimídia proposta, percebemos que é viável a realização e construção de outras tecnologias da informação

Due to the integration of New Technologies of Information and Communication in the nursing practice, we note that this can be an important learning tool and can contribute to a performance of nursing staff more effective. Thus, the study object of this research was to interactive multimedia aimed at the proper use of sharps with safety device for peripheral venipuncture. The Main Objective was to develop an interactive multimedia aimed at the proper use of sharps with safety device. Methods: the method adopted was the quantitative and qualitative, being a study of observational type. Results: As regards the time of peripheral venous puncture, note that although the recommendation for hand hygiene is mandatory and that this should precede any procedure to be performed, only 20% of participants did before venous puncture and; 2 - In the last step of the procedure performed, the data that draws our attention is that 80% of participants did not perform the calculation for the infusion of drugs, carrying out the initial infusion randomly. Conclusion: it was identified the need for a new approach for the specific training of sharps with safety device, once with the development of our multimedia proposal, we realized that it is feasible the realization and construction of other information technologies

Técnica de preparo de medicamentos parenterais: tocar ou não no êmbolo? / Technique for the preparation of parenteral drug: touching or not touching the piston?

No preparo de medicação, cabe ao profissional manter a segurança microbiológica evitando que ocorra contaminação. Um dos pontos descritos para evitar a contaminação do líquido aspirado por meio de seringas é não tocar no êmbolo durante o preparo da medicação. Esta pesquisa teve como objetivos descrever as recomendações técnicas quanto a tocar ou não no êmbolo de seringas e demonstrar, por meio de um experimento, se ocorre contaminação do meio de cultura aspirado após o toque nesse êmbolo. Trata-se de estudo descritivo, microbiológico, laboratorial, campo simulado, realizado em laboratório de microbiologia do Centro Universitário de Votuporanga/SP, em 2005. Aspirou-se meio de cultura através de 40 seringas, após tocar vigorosamente no êmbolo de cada uma com as mãos previamente higienizadas. Resultado: houve ausência de crescimento microbiano em todas as amostras testadas após 72 horas de incubação. Conclui-se que tocar no êmbolo não acarretou contaminação.

A novel method for subarachnoid drug delivery in the medullary region of rats.

This study describes a novel method for direct subarachnoid drug delivery to the medullary dorsal horn region of rats, without introducing a catheter. The reliability of the method was demonstrated by a pharmacological validation; that is, morphine administration to the medullary region blocked the nociceptive response to formalin injected in the temporomandibular joint (TMJ) region, an effect that was prevented by co-administration of naloxone. The method proposed offers many advantages over the existing methods for medullary drug delivery with catheter implantation. It is easy to be employed, it does not induce any sign of motor impairment, and it does not require the neck surgery performed to implant a catheter in the medullary dorsal horn region. Therefore, it is a useful method for subarachnoid drug delivery in behavioral trigeminal pain studies, particularly when nociceptive behavioral measures that require normal neck muscle activity to occur, such as head withdraw or head flinch, are evaluated.

Escalpe, equipo de soro e seringa descartável: critérios qualitativos para subsidiar a compra / Butterfley needle, infusion set and syringes: requirement of quality of the purchasing

Este estudo objetivou investigar o conhecimento da enfermeira sobre o processo de aquisiçäo de materiais conforme precinizado pela legislaçäo vigente no Serviço Público. Além disso procurou-se reconhecer a forma de participaçäo e as opiniöes quanto aos requisitos essenciais de qualidade para compra de alguns materiais (escalpe, equipo de soro e seringa descartável), propostos para este estudo. O levantamento foi realizado em 1987, em seis hospitais públicos da Secretaria do Estado da Saúde de Säo Paulo, utilizando um formulário específico como instrumento de coleta de dados, aplicado a 62 enfermeiras das unidades de internaçöes e 13 enfermeiras-Chefe/Diretora. Como resultado obteve-se que: o conhecimento das enfermeiras no processo de aquisiçäo de materiais mostrou ser parcial e compartimentalizado; sua participaçäo se dava em apenas algumas fases do processo (na indicaçäo e especificaçäo de objetos e na designaçäo de um elemento para participar no processo de compra). Sobre a participaçäo no processo, em opiniäo individual, cada enfermeira enfatiza a necessidade de ser ouvida a respeito dos materiais, na condiçäo de usuária devido ao seu conhecimento. No levantamento de requisitos de qualidade desse materiais, a populaçäo entrevistada demonstrou ter conhecimentos suficientes dos critérios para subsidiar a compra.