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Gamlen Tableting Ltd: Low cost, instrumented force- and displacementcontrolled tableting press for replication of full-scale production pharmaceutical tablets from a laboratory-scale device

Gamlen Tableting Ltd: Low cost, instrumented force- and displacementcontrolled tableting press for replication of full-scale production pharmaceutical tablets from a laboratory-scale device
Gamlen Tableting Ltd:低成本、仪表化力和位移控制压片机,用于通过实验室规模的设备复制全规模生产的药片
批准号:
720394
负责人:
金额:
$12.8万
依托单位:
依托单位国家:
英国
项目类别:
GRD Development of Prototype
财政年份:
2014
资助国家:
英国
项目状态:
已结题
起止时间:
2014 至 --

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中文摘要
翻译
Gamlen Tabletting(GT)是一家中小型企业,成立于2012年,旨在为制药行业和学术界开发一种准确,易于使用,小规模,低成本的仪器化压片机。推出的产品,500公斤负荷的Gamlen压片机(GTP)已经在市场上销售了一年,并已被GSK独立验证为生产片剂,准确复制了全规模生产机器的特性。500公斤的GTP已被用于处方前研究,处方开发,过程控制,QC测试,教学和研发,目前和潜在用户的反馈表明,需要更高的压实载荷(以便能够压缩更广泛的粉末)以及额外的仪器,以更好地评估粉末特性。500公斤的GTP已经在行业领先的公差下运行;开发更大,更高容量的机器,同时保持精度,这对GT在结构和控制方面提出了重大的技术挑战。GT提出了一个为期15个月的项目,开发和演示原型增强GTP。工作将集中在:·机器改进:增加机器的额定负载,以更准确地复制全面的生产加工条件;·螺栓连接的附加功能:片剂弹射力测量和片剂标签模块;·压缩曲线分析:能够在压缩事件期间研究材料特性。这将进一步扩大实用性并增加市场潜力;·开发标准化的粉末压缩性测试:这将使用户能够轻松识别可用于生产高质量片剂的粉末。GT将通过进行内部工作的各个方面来最大限度地提高资金价值,同时将超出当前能力的任务分包出去。
英文摘要
Gamlen Tabletting (GT) is an SME, established in 2012 to develop an accurate, easy to use,small scale, low cost, instrumented tableting machine for the pharmaceutical industry andacademia. The launch product, a 500kg load Gamlen Tablet Press (GTP) has been in themarket for a year, and has been independently verified by GSK as manufacturing tabletswhich accurately replicate the characteristics of those from full-scale production machinery.The 500kg GTP has found use in pre-formulation studies, formulation development, processcontrol, QC testing, teaching and R&D, where it has found widespread acceptance.Feedback from current and potential users indicates the need for higher compaction loads (toenable the compression of a wider range of powders) plus additional instrumentation to betterassess powder characteristics. The 500kg GTP already operating at industry-leadingtolerances; developing a larger, higher capacity machine while maintaining accuracy posessignificant technical challenges to GT in terms of both construction and control.GT proposes a 15 month project to develop and demonstrate a prototype enhanced GTP.Work will focus on:• Machine improvements: to increase the load rating of the machine to more accuratelyreplicate full-scale production processing conditions;• Bolt-on additional functionality: tablet ejection force measurement and tablet labellingmodules;• Compression curve analysis: to enable the study material properties during the compressionevent. This will further extent utility and increase market potential;• Developing standardised powder compressibility tests: this will allow users to easily identifypowders that will make high quality tablets.GT will maximise value for money by conducting aspects of the work in-house, whilesubcontracting tasks that are outside of current capability.
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