- GMP and Compliance
- Pharmaceutical Product Development
- Developing Pharmaceutical Tablets for Low Cost Manufacturing
- Development and Manufacture of Effervescent Tablets
- Discussion Group - QbD and Lifecycle Management for Analytical Methods
- HPLC Analytical Method Development and Validation
- Hands-on Tablet Development including the principles of pre-formulation, formulation and process dev
- Introduction to Photostability
- Pharmaceutical Packaging - an introductory course
- Pharmacokinetics in Drug Development - an integrated approach
- Preformulation Studies for Tablet Development
- QbD and Lifecycle Management for Analytical Methods
- Stability Testing in Pharmaceutical Development and Manufacture
- Tablet Formulation Development
- Tablet Formulation Development - Formulation development in practice
- Tablet Process Development, Validation and the Application of QbD
- Technology Transfer
- Pharmaceutical Manufacturing Support
- Pharmaceutical R&D Support
- In-house Training Courses
Preformulation Studies for Tablet Development
No Course Dates Currently Available
Description
The course will cover:
The Product Development Lifecycle
- Making sense of ICH Q8, 9 and 10
- Identifying the material properties at an early stage which will become Critical Quality Attributes of the product
Preformulation studies
- Material characterisation - chemical and physical
- Morphic form identification
- Salt selection
- Compressibility testing
- Excipient and Process compatibility testing
New Techniques and how to apply them
- Atomic Force Microscopy
- ASAP - short term high stress testing for accurate shelf life assessment
- Raman Spectroscopy and other mapping techniques
- Amorphous materials - uses and limitations
- Quantitative and Environmental XRPD
- Solid state NMR
- Evaluating drug substance compressibility
Overview
This unique 2 day course identifies the studies needed to characterise the physico-chemical properties of drug substances in the context of tablet development. Proper understanding of drug substance properties is essential for both candidate selection (during the Research process) and pharmaceutical development.
On Day 1 of the course we introduce the key elements of tablet development and the principles of Quality by Design (QbD), and the potential impact of drug substance properties on tablet development. On Day 2, we study some of the numerous recently developed techniques for rapid and scientific assessment of drug substances using techniques such as Atomic Force Microscopy (AFM), high stress stability testing (ASAP - Waterman), and Raman Spectroscopy. We include experimental, hands - on experience of material compaction using the new Gamlen Tablet Press.
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 the influence of material properties on processing behaviour, and regulatory and quality personnel who need to understand the development process.
Numbers are restricted for maximum benefit to participants
Course Programme
Day 1: Introduction to preformulation
Morning
- Developing a Target Product Profile
- The product development process
- What are 'Preformulation studies'
- Linking material properties to formulation and processing behaviour
Afternoon
- Identifying potential Critical Product Attributes related to the drug substance
- Established techniques for materials characterisation
- Linking material properties to formulation requirements
Day 2: Advance preformulation techniques
Morning
- Atomic Force Microscopy
- ASAP - short term high stress testing for accurate shelf life assessment
- Raman Spectroscopy and other mapping techniques
- Amorphous materials - uses and limitations
- Quantitative and Environmental XRPD
Afternoon
- Solid state NMR
- Evaluating drug substance compressibility
- Case studies, workshops
- Participants open forum and Question and Answer session
- Practical
- Effect of crystal form on compressibility using the Gamlen Tablet Press
NOTE 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.
