Corporate Banner
Satellite Banner
Genomics
Scientific Community
 
Become a Member | Sign in
Home>Events>This Event
  Events - September 2013


Hands-on Tablet Development, including the principles of Pre-Formulation, Formulation and Process Development

11 Sep 2013 - 13 Sep 2013 - London, UK



Bookmark and Share


This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. Each day will consist of lectures on aspects of tablet development, followed by linked sessions in which participants take part in related experimental work.The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD).

Learning outcomes:

  • Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development
  • Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility
  • Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development

Who Should Attend?

  • Newcomers to tablet formulation development and manufacturing
  • Production operators who need a better understanding of their products and how they have been developed
  • Analytical and QC staff who would benefit from understanding the tablet development and production process
  • Experienced personnel in one area of product development who need a broader overview
  • Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives
  • Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers
  • Regulatory agency staff requiring practical experience

Course Programme

Day 1

Theme

  • Quality by Design (QbD) - ICH Q8-10
  • Material properties and their impact on processing
  • The role of excipients Course Programme

8.30am Registration and coffee/tea

9.00am Welcome. Introductions. Plan for the day. Learning objectives for course

9.15am Introduction to Quality by Design - a new pharmaceutical manufacturing system. Regulatory guidance.

10.45am Coffee break

11.00am Drug substance properties and their impact on formulation development.

Part 1 - physico-chemical properties

12.45pm Lunch

1.45pm Drug substance properties and their impact on formulation development.

Part 1 - physico-chemical properties

3.00pm Tea break

3.15pm Practical - impact of material properties on bulk powder behaviour

  • Flow
  • Bulk density
  • Compressibility
  • Particle size and shape

4.45pm Wrap up

5.00pm Close

Day 2

Theme

  • Formulating good products

9.00am Consolidation. Plan for day. Learning objectives for day

9.15am Approaches to formulation development using QbD principles. Manufacturing Process selection - applicability of wet granulation/roller compaction/direct compression. Unit processes 1 - blending.

10.30am Coffee break

10.45am Unit processes 2 - granulation and drying. Factors affecting granulation and drying behaviour. Critical Process Parameters for these processes. Impact of powder properties on manufacturing behaviour

12.15pm Powder and granule characterisation - advanced techniques. Porosity, compressibility, surface area

12.45pm Lunch

1.30pm Granulation and drying practical

3.00pm Tea break

3.15pm Lubrication and compression practical

4.45pm Wrap up

5.00pm Close

Day 3

Theme

  • Process development and validation

9.00am Consolidation. Plan for day. Learning objectives for day

9.15am Principles of process development. FDA Process Validation Guidance 2011 and the impact of QbD

10.30am Coffee

10.45am Identifiying Critical Process Parameters and Critical Quality Attributes

  • Blending
  • Granulation
  • Drying
  • Lubrication
  • Compression

12.45pm Lunch

1.45pm Practical - Direct compression products

Impact of excipient selection, grades, and processing on critical quality attributes

  • Compressibility
  • Friability
  • Content Uniformity
  • Disintegration

4.00pm Closing session with tea

5.00pm Depart



Further information
Scientific News
Cell Transplant Treats Parkinson’s in Mice
A University of Wisconsin—Madison neuroscientist has inserted a genetic switch into nerve cells so a patient can alter their activity by taking designer drugs that would not affect any other cell.
Understanding Female HIV Transmission
Glowing virus maps points of entry through entire female reproductive tract for first time.
Genetic Markers Influence Addiction
Differences in vulnerability to cocaine addiction and relapse linked to both inherited traits and epigenetics, U-M researchers find.
A lncRNA Regulates Repair of DNA Breaks in Breast Cancer Cells
Findings give "new insight" into biology of tough-to-treat breast cancer.
Detection of HPV in First-Void Urine
Similar sensitivity of HPV test on first void urine sample compared to cervical smear.
Shape Of Tumor May Affect Whether Cells Can Metastasize
Illinois researchers found that the shape of a tumor may play a role in how cancer cells become primed to spread.
Computational Model Finds New Protein-Protein Interactions
Researchers at University of Pittsburgh have discovered 500 new protein-protein interactions (PPIs) associated with genes linked to schizophrenia.
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Analysis of Dog Genome will Provide Insight into Human Disease
An important model in studying human disease, the non-coding RNA of the canine genome is an essential starting point for evolutionary and biomedical studies – according to a new study led by The Genome Analysis Centre (TGAC).
New Insights into Gene Regulation
Researchers have solved the three-dimensional structure of a gene repression complex that is known to play a role in cancer.
Scroll Up
Scroll Down
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,400+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!