ZOOM Online: Powder Technology for Pharmaceutical Development and Manufacturing
Powder properties have a major impact on formulation, development and manufacturing of Oral Solid Dosage forms. They also play an important role in meeting the requirements of Quality by Design for OSDs.
In this course we examine powder properties and their role in these important processes, so that attendees can understand
- The influence of drug substance properties on formulation development how and why particular tablet components are selected and what impact they have on powder properties and tablet behaviour
- Manufacturing method selection and the importance of powder flow Mechanisms of powder mixing and segregation
- Powder properties, Critical Quality and Material Attributes, and the Product Control Strategy
- Effects of blending behaviour and scale on Critical Process Parameters
- The relationship between input material properties and tablet properties
Proper integration 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 based on powder technology, many development and production problems can be avoided, and formulation robustness can be improved. The course includes case studies of tablet formulation development and a detailed step by step analysis of all elements of the tablet manufacturing process.
By the end of the course the attendees will be able to recognise key powder properties which affect process performance, and make improved judgements about how to improve processes.
Day 1
Introduction to powder technology
- Key powder properties
- Solid state properties of materials
- Measuring material properties
Pharmaceutical Processing
- Impact of formulation and process on powder and tablet properties
Controlling Powders
- Setting (the right) technical specifications for raw materials and deciding on analytical methods and parameters
Tablets and their properties
- Tabletability
- Compressibility
- Compactibility
- Tensile Fracture Stress
- Impact of material properties on tablet properties
Day 2
Regulatory background
- Developing advance process understanding
Manufacturing Methods
- Impact of powder properties on manufacturing method selection and processing properties
Controlling Processes
- Using powder properties to control manufacturing processes – possibilities and limitations
Sampling techniques
- Sampling excipients
- Sampling intermediates and blends
- Sampling finished products
Process Risk assessment and Identifying CPPs and CQAs
- Use of Risk and Process Matrixes
- Identifying Critical Process Parameters
Day 3 – Practical
Morning – measuring powder properties
See the impact of material properties on bulk powder behaviour.
Measurements of the following:
- Powder Flow
- Bulk density
- Compressibility
- Particle size and shape
On a range of excipients.
Afternoon – making tablets and their properties
- Tabletability
- Compressibility
- Compactibility
- Tensile Fracture Stress
- Impact of starting materials and process
Michael Gamlen (Tableting and Stability Testing Expert)
Michael is managing director of Pharmaceutical Development Services Limited, a Nottingham UK-based technical consultancy. Michael has over 30 years experience of tablet development. Awarded a first class honours degree in pharmacy, specialising in pharmaceutical engineering. He studied for a PhD at Nottingham University. He was head of tablet development at the The Wellcome Foundation for 15 years, and has since worked for Vanguard Medica Limited and as a consultant. He specialises in managing product development, formulation, tablet and process development studies. He has been teaching professional tabletting courses for many years. His courses are highly rated, often exceeding the expectation of participants.
Michael continually updates the content of his courses with guidance and extracts from latest scientific papers. He provides a substantial amount of relevant literature to all course participants and copies of all notes and guidance used. He is very popular presenter.
NULL
NULL
