Powder Technology for Pharmaceutical Development and Manufacturing

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Tutor : Michael Gamlen
DateLocationFee 
25 - 27 September 2019
Croydon, Greater London
Croydon, Greater London £1,770
£1,593 + Vat
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Before 31 July 2019
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Before 31 July 2019

Overview

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.

Course Programme

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
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