Powder Technology for Pharmaceutical Development and Manufacturing

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: