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  Events - December 2012


Tablet Formulation Development (2 day)

03 Dec 2012 - 04 Dec 2012 - London, UK



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This unique course introduces and integrates the key elements of tablet development with the principles of Quality by Design (QbD) with 2 days of theory plus an optional practical day in our development laboratory. It will include experimental, hands-on experience of formulation development using the Gamlen Tablet Press.

Topics include:

·    Applying Quality by Design at the development phase

·    Relating drug substance properties to desired formulation characteristics

·    Development formula and process - how these are linked

·    Identifying processes which will minimise development and manufacturing costs

·    Developing the Product Control Strategy - Critical Quality Attributes and Critical Process Parameters

·    Using novel science - PAT, NIR, Atomic Force Microscope, real time particle analysis

Proper 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 formulation development and 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.


Who should attend?
The course is designed for people new to tablet development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why products processes can go wrong, and regulatory and quality personnel who need to understand the development process.

Course Programme:
Day 1 The Product Development Lifecycle
. Making sense of ICH Q8, 9 and 10—moving from theory to practice
. Designing formulations and processes to meet the Target Product Profile
. Formulation development—Formula and process selection
. Product Optimisation and the formulation cycle
. Developing Product Control Strategies at the formulation development phase
. Tablet Film Coating polymers
Day 2 Advance characterisation and development techniques
. Formulation mapping using X-ray and Raman spectroscopy
. AFM in formulation development
. Real time particle size analysis
. Dryer control using NIR
. Blend uniformity assessment using NIR and other techniques
. Compressibility comparison using the Gamlen Tablet Press
. Characterisation of tablet coats using THz spectroscopy
Day 3 Formulation development in practice (BOOK SEPARATELY) (HANDS ON. LIMITED TO 10 participants only)
. Material characterisation for product development
. Direct compression
. Wet granulation
. Drying
. Milling
. Compression
. Formulation evaluation and final selection
Wherever possible participants should bring practical problems and examples which can be reviewed on the course. The course will be highly participative and useful for people with or without formulation experience.

Course Speakers: Dr Michael Gamlen and Dr Dipankar Dey


Further information
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Engineers at Washington University in St. Louis found a way to keep a cancerous tumor from growing by using nanoparticles of the main ingredient in common antacid tablets.
Future of Medicine Could be Found in a Tiny Crystal Ball
A Drexel University materials scientist has discovered a way to grow a crystal ball in a lab. Not the kind that soothsayers use to predict the future, but a microscopic version that could be used to encapsulate medication in a way that would allow it to deliver its curative payload more effectively inside the body.
Improving Delivery of Poorly Soluble Drugs Using Nanoparticles
A technology that could forever change the delivery of drugs is undergoing evaluation by the Technology Evaluation Consortium™ (TEC). Developed by researchers at Northeastern University, the technology is capable of creating nanoparticle structures that could deliver drugs into the bloodstream orally – despite the fact that they are normally poorly soluble.
Faster Drug Discovery?
Startup develops more cost-effective test for assessing how cells respond to chemicals.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Nanoparticles Deliver Tumor Suppressors to Damaged Livers
UT Southwestern Medical Center chemists have successfully used synthetic nanoparticles to deliver tumor-suppressing therapies to diseased livers with cancer, an important hurdle scientists have been struggling to conquer.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
A New Type of Anticancer Agent
Success in the development of a ?-tubulin specific inhibitor.
Nanoparticles Proven Effective Against Antibiotic-Resistant “Superbugs”
In the ever-escalating evolutionary battle with drug-resistant bacteria, humans may soon have a leg up thanks to adaptive, light-activated nanotherapy developed by researchers at the University of Colorado Boulder.
Versatile New Molecule-Building Technique
Chemists at The Scripps Research Institute (TSRI) have devised a new and widely applicable technique for building potential drug molecules and other organic compounds.
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