肠外注射的中试工厂放大研究综述

V. Manikandan
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引用次数: 0

摘要

注射剂的剂型是无菌的,能迅速开始起效,并能立即在体内完成药物作用。对于生物利用度较差的动态药物和治疗指标较紧的药物,肠外给药途径是最知名和最有效的途径。该技术的主要目的是努力讨论中试工厂生产考虑所需的不同程序。中试工厂是一个术语,通常比大规模生产工厂更温和,但它是规模的潜在范围。它是为学习而计划的,并在有限的范围内做出定义,以完成与巨大范围生产的关系,它们通常更具适应性,可能会损害经济。大多数试点工厂都隐含在制造商自己的研究中心,制造商使用库存实验室硬件。这些试验工厂的研究是通过使用技术转让(TT)文件报告进行的,该报告是由研发部门为产品开发而制作的。因此,该工艺将满足产品质量,安全性和有效性,并且该生产技术将转移到肠外制剂的大规模生产。
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PILOT PLANT SCALE-UP STUDIES FOR PARENTERAL - A REVIEW
The dosage form of parenteral is sterile and gives a quick beginning of activity and gives an immediate action to accomplishing the medication impact inside the body. The route of parenteral administration is the most well-known and productive route for the conveyance of dynamic medication substances with poor bioavailability and medications with a tight therapeutic index. The principal objective of the technique was to endeavour to talk about the different procedures needed for the pilot plant production considers. The pilot plant is the term that is normally more modest than large-scale production plants yet it is the underlying scope of sizes. It is planned for learning, and making the definitions on a limited scale to accomplish the relationship with the enormous scope production, and they are normally more adaptable perhaps to the detriment of the economy. Most of the pilot plants are implicit in the maker's own research centres of the manufacturer utilizing stock lab hardware. These pilot plant studies are performed by using a technology transfer (TT) documentation report which is made by the research and development department for product development. Hence, this process would meet product quality, safety, and efficacy and further this production techniques will transfer to large-scale production for parenteral preparation.
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