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Powder Technology for Pharmaceutical Development and Manufacturing

24 February 2016 08:30 - 26 February 2016 17:00, London, United Kingdom


Introduction
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

 
Speakers
  • Dr Michael Gamlen United Kingdom

Venue
DoubleTree Hilton Islington

DoubleTree Hilton Islington , 60 Pentonville Road, London, N1 9LA, United Kingdom

Useful links

Organised by
PharmaCourses Ltd
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