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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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February 01, 2011 |
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PharmaTraining Ltd, CCIT, The Technology Centre of New Jersey
7 & 8 April 2011
This unique 2 day course introduces and integrates the key elements of tablet development with the principles of Quality by Design (QbD). It will include experimental, hands-on experience of formulation development: The Product Development Lifecyle · Making sense of ICH Q8, 9 and 10 · Identifiying the material properties which will become
Critical Quality Attributes at an early stage Preformulation studies · Material characterisation · Morphic form identification Salt selection · Compressibility testing · Excipient and Process compatibility testing · Applications of advanced techniques to aid development including AFM Formulation development · Formula selection · Process selection · Product Optimisation and the formulation cycle · Advanced Intermediate and Product characterisation · Develping Product Control Strategies at the formulation development phaseProper integration of all of these elements is essential to achieve “Quality by Design” because data from each phase is used to control the next step in the development process. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet development at the preformulation and formulation development phases as well a detailed step by step analysis of all elements of the tablet manufacturing process. Hands on, practical studies will underpin the scientific learning in this participative course. Day 1: Preformulation Morning Developing a Target Product ProfileThe product development processWhat are “Preformulation studies”Linking material properties to formulation and processing behaviour Afternoon Identifying potential Critical Product Attributes related to the drug substanceAdvanced material characterisationLinking material properties to formulation requirements Practical Effect of material properties on powder mixing behaviour Day 2: Tablet formulation—an introduction Morning Selecting the right formulation for the drug and target product profile based on the properties of the drug substanceKey unit operations and their Critical Process ParametersPutting it altogether—building a coherent manufacturing process Afternoon Case studies, workshopsUse of the Precision Compaction TesterParticipants open forum and Question and Answer session. Practical How do tablets stick together? Developing a “fair test” to evaluate compressibility
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Organized by:
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PharmaTraining |
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Invited Speakers:
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Dr Michael Gamlen, Pharmaceutical Development Services
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Deadline for Abstracts:
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Registration:
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£1180. Registration is available on website: http://pharma-training-courses.com/integrated-tablet-formulation-development.html
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E-mail:
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judy@pharma-training-courses.com
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