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English to Chinese: Prefilled syringes General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English Prefilled syringes: An innovation in parenteral packaging
Sagar Makwana, Biswajit Basu, Yogita Makasana,1 and Abhay Dharamsi
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Abstract
Parenteral administration of pharmaceutical products is one of the most popular methods used to produce quick onset of action and also 100% bioavailability. Main problem occurs with the parenteral drug delivery is lack of convenience, affordability, accuracy, sterility, safety etc. Such drawbacks with this delivery system makes it less preferable. Hence, all the disadvantages of these systems can be easily overcome by use of prefilled syringes. The objective of this review article is to provide information regarding prefilled syringes; it's method of preparation, direction to use, advantages, its future scope, and development.
Keywords: Bioavailability, parenteral, prefilled syringes
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INTRODUCTION
There are over 20 pharmaceutical companies manufacturing prefilled syringes as preferred delivery device for at least 50 injectables drugs and vaccines that have total combined annual sales of approx. US $500.[1,2] Prefilled syringes are now used across a wide array of therapeutics sectors outside of the traditional domains of anticoagulants and vaccines. The use of prefilled syringes is expected to accelerate over the coming decades. For the pharmaceutical company, the advantages of prefilled syringes are minimizing drug waste; increasing product life span and enhancing level of market share are some of driving market demand. For healthcare workers, prefilled syringes are recognized as an efficient, reliable and convenient method for drug administration. Furthermore, the ease at which patient can self-administer many types of injectables drugs make prefilled syringes of healthcare treatment out of hospital and into home.[1,2] So, in future emerging challenge in the pharmaceutical market for prefilled syringes will be there. This broad acceptance of prefilled syringes is not surprising because of the range of compelling benefits including simplicity, suitability for home use, reduction in wasted products, and greater dose precision. Prefilled are convenient and help ease the administration process.[3] Patient does not have to worry about the transfer of a drug from a vial to a syringe and therefore do not have to worry about leaving a small percentage of dose behind.
Prefilled provide greater patient safety by reducing the potential for inadvertent needle sticks and exposure to toxic products that can occur while drawing medication from vials.[4,5] Prefilled syringes, with their pre measures dosage, can reduce dosing errors and increase patient compliance. Prefilled syringes can virtually reduce the manufactures need to overfill unlike vials those are overfill by as much 20-30% to account for potential waste. This is particularly important where manufacturing and product costs are high and bulk manufacturing capacity is low. Overall, this compilation of paper is not covering energy aspects of the field of prefilled syringes, but aims to provide the reader with a better understanding of this dynamically growing field of parenteral application system.[6,7] Prefilled Syringes assures delivery of particulate free solution and accommodate volumes that typically range from 0.25 to 5.0 ml. They are therefore best suited to products administered by subcutaneous or intramuscular injection. Three categories account for the bulk of PFS: anti-thrombotics, vaccines, and biotech drugs.
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ADVANTAGES
0Prefilled syringe cartridges are designed to fit into specialized syringes, which are used to administer various fluid medications. These are used in the position of standard syringes, which practitioners must fill manually before each does is administered. The first prefilled syringe cartridges were made of polypropylene. The advantages of prefilled syringe cartridges are their convenience, affordability, accuracy, sterility, and safety.[8]
Convenience
During an emergency (an allergic reaction), filling of standard syringes can be a time-consuming and complicated process, so that requires a quick injection syringes. Prefilled syringe cartridges can save time, and sequentially save lives. Prefilled cartridges allow injections to be administered more quickly specially in a busy hospital. They can diminish overcrowding in emergency rooms and other treatment areas.[9]
Affordability
Standard syringes feature cylindrical glass barrels and tightly fitting glass rods, which are much more expensive to manufacture in comparison to plastic-base prefilled cartridges and their corresponding syringes. Additionally, prefilled cartridges are much less prone to crack or break in comparison to their standard, glass counterparts.[10,11]
Accuracy
Prefilled syringe cartridges assure that patients receive accurate dosages. This is especially advantageous for patients who need to self-inject medication, but have no medical training. According to boschpackaging.com, with standard syringes it is possible to overfill (or under fill) the barrel, which could negatively impact the efficacy of the treatment.[12,13]
Sterility
Once a standard syringe is filled with a medication, it will remain optimally effective, or sterile, for approximately 12 hours. In comparison, a medication stored inside of a prefilled syringe cartridge will remain sterile for approximately two to three years (this is also referred to as a “shelf life” of two to three years).
Safety
Prefilled syringe have a high level of accuracy, which makes them safer to use. Some cartridges are designed to fit into self-aspirating syringes, which essentially pierce the skin and inject medications without having to push on a plunger. This ensures that injections reach the appropriate depth, and that dosages are administered smoothly.
Medical advantages
Healthcare professionals benefit from accurate, pre-measured doses, reduced dosing and medication errors, and reduced risk of microbial contamination. Prefills are convenient for emergency use and have potential for duplicate peel-off labels, which facilitate patient charting. Single-use prefilled syringes typically do not require preservatives. In fact, in studies conducted recently, nine out of ten healthcare professionals preferred prefills to conventional needles and syringes.[10]
Manufacturing advantages
Another key advantage is that prefills require less overfill. For example, for a 0.5 ml vial, the USP recommends 20-25% overfill. In contrast, for a 0.5 ml, required overfills is less than 2%. As a result, potentially 18-23% more doses can be produced. Simple and flexible processing formats make prefills easier to incorporate into a pharmaceutical company manufacturing line.[10]
Marketing advantages
Not only do healthcare providers prefer prefills, but healthcare products are also accepted and well known globally. Products can be found in virtually every hospital in the US and overseas. This real-time exposure gives us a unique opportunity to develop products for customers that will be well accepted by their ultimate recipients – end-users, doctors, and other healthcare professionals.[10]
Translation - Chinese 预填充注射器：肠道外注射用药物包装的革新
Sagar Makwana, Biswajit Basu, Yogita Makasana,1 and Abhay Dharamsi
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摘要
制药产品的肠胃外投药是最通常的手段之一，用于产生快速反应以及100%生物利用度。肠道外给药主要问题发生在不方便、负担能力、精确度、无菌、安全等。此类缺点使得肠外给药变得不那么可取。今后，这类系统所有的缺点可通过应用预填充注射器轻松克服。本文主题是针对预填充注射器提供信息：这是制备方法、使用方法、优点、未来范围及发展。
关键词：生物利用度、肠胃外、预填充注射器
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介绍
现在有超过20家制药公司生产预填充注射器，作为优先采用的给药装置，用于至少50种可注射药物和疫苗，总的综合年销售额在500美元。预填充注射器目前广泛应用于治疗部门，超出了传统的抗凝血剂和疫苗的范围。我们可以期待在未来的数十年里预填充注射器的使用加速增长。对于制药公司，预填充注射的优点在于减少药物浪费；增加产品使用期限以及增加市场占有率水平等市场需求驱动的一些方面。对于医疗卫生的工作人员，预填充注射器被认为是一种高效可靠并且方便的投药方法。另外，由于患者可以方便地针对很多种类的注射药物自我给药，自我管理使治疗得以在医院以外的地方甚至家中进行。此种对于预填充注射器广泛的接受并不令人惊讶，因为引人注目的益处包括简易、适合家庭使用，减少废弃产品、增加给药精确度。预填充方便并且有助于投药过程简单化。患者不必担心从西林瓶中抽取药品到注射器，因此不用担心瓶子里还剩下少量的药品。
,通过减少在从西林瓶抽取药液时潜在的针头疏忽和毒性产品暴露，预填充提供了更大的患者安全性。预填充注射器，由于其预先称量的药量，可以减少给药错误并且增加患者依从性。预填充注射器可以事实上减少生产商过量装填药物，不像西林瓶，通常要过量装药20-30%以抵消潜在的药物浪费。这一点对于生产成本和产品成本高、并且生产批量小的情况下尤其重要。总的来说，本编并未考虑预填充注射器对于能量方面的影响，只是使读者对于肠胃外应用系统的动态化增长领域有一个良好的理解。预填充注射器确保了无颗粒溶液的给药，其所容纳的药量典型的在0.25到5.0ml。因此预填充注射最适合皮下注射和肌肉注射。适合PFS的有三类应用：抗血栓、疫苗和生物药物。
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优点
预填充注射器针筒被设计为适合专业化的注射，用于投放不同的液体药物。这些用于标准注射，在以前每个注射，从业者必须人工充填。第一个预填充注射器由聚丙烯制成。预填充注射器针筒的优点是其方便性、负担能力、精确度、无菌性和安全性。
方便性
在紧急情况下（过敏性反应），填充一个标准的注射器需要耗时和复杂的过程，所以需要一个快速的注射器。预填充注射器针筒可以节省时间，从而挽救生命。预填充针筒使得注射剂投药更加快捷，特别在繁忙的医院里。他们可以减少在过于拥挤的急诊室和其它处理区域的时间。
负担能力
标准的注射器有量杯玻璃桶和紧密配合的玻璃推杆，相比塑料为基础的预填充注射卡瓶和相应注射器来说，标准注射器要更贵。]另外，对比标准的玻璃制产品，预填充注射器更不易破裂或破碎。
精确度
预填充注射器确保了患者接收到准确的剂量。这对于患者需要自行注射给药、又未经医药训练的的场合是很大的优点。依据博世公司资料，对于标准注射器，可能过量填充（或不足）针筒，这会对治疗效果产生负面影响。
无菌性
当一个标准的注射器灌入药物，其最佳的有效、或无菌的期限是12小时。作为对比，药物储存在预填充注射器针筒内将会保持无菌状态大约2到3年时间（这也被称为保存期2到3年）。
安全
预填充注射器具有高精确度，使它们应用更安全。某些注射器被设计为适合自吸注射，可基本上刺穿皮肤并注射药物，不需要推动推杆的动作。这确保了注射达到一个合适的深度，剂量管理平稳。
药物优点
医药专业得益于精确、预先称量的剂量、剂量和药物错误的减少，还有减少的微生物污染风险。预填充方便地应用于紧急情况，并且具有潜在的可能性用于双剥离标签，便于患者记录。单次使用的预填充注射通常不要求防腐保存。事实上，在最近的研究分析中，相比传统的针头和注射器，十分之九的医疗专业人员倾向于预填充。
制造优势
另外一个关键优点是预填充所要求的过量充填较少。例如，对于0.5ml的西林瓶，USP要求20-25%过充填。与之相对照的，对于0.5ml的预填充，所要求的过充填少于2%。因此相当于潜在地增加了18-23%的产量。简单而又灵活的工艺要求使得预填充能够非常方便地与一家制药企业的生产线相结合。
市场优势
不仅仅是医疗提供者倾向于预填充，医疗产品也在全球范围内广泛接受这项技术。在美国和海外几乎每家医院都可以找到这样的产品。这种实时的披露给了我们一个独特的机会去为客户开发产品，以便为他们的最终的受众——最终用户、医生和其他医疗专业人士所接受。
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Years of experience: 14. Registered at ProZ.com: Dec 2016.
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