Industries: Pharma / Biotech

Formulation Design and Troubleshooting of Dry Dosage Forms (Tablets and Capsules)

Course Director: Michael Gamlen, Ph.D.

Course Description - Course runs 9:00 to 5:00 both days

This two-day course will explain the principles of dosage form design and how poor decisions at the design stage result in unstable processes and problem products. Product design should begin with identification of critical process and material parameters, but all too often this stage of the development is rushed and product yield and quality are compromised. Rectifying these problems retrospectively can be difficult and expensive. "Right first time" is the key to success.

This program will also identify the key elements of a successful product, along with some novel techniques which can be applied both as development and as troubleshooting tools. The course will benefit personnel working in formulation and product development, manufacturing, product support, and regulatory affairs. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet formulation development and a detailed step by step analysis of all elements of the tablet manufacturing process.

Upon completing the course, all participants will have a comprehensive understanding of the principles of formulation development and how they can be used to understand and troubleshoot manufacturing issues and problems, and improve productivity.

Who Should Attend

This course has been created to assist those involved in the formulation design of tablets and capsules including identifying and troubleshooting design and production issues that may arise. The course will be especially useful for those involved in:

  • Pre-formulation and Formulation development
  • Tablet and capsule product and process development
  • Tablet and capsule production troubleshooting support staff
  • Process Development who wish to extend their understanding of the relationship between formulation and process, and how formulations are selected in the real world
  • Regulatory and quality areas who need to improved understanding of tablet and capsule manufacturing technologies

Attendees are encouraged to bring specific problems for the group to consider.

First Day

Introduction to the Course

Quality by Design: What is it and How it Changes the Product Development Process

  • Target product profiles
  • Product and process selection
  • Critical Quality Attributes and Critical Process Parameters
  • Quality

Tablet and Capsule Product Types

  • Product type selection

Principles of Tablet and Formulation Development

  • The Lifecycle approach to product development
  • Evaluating products and processes
  • Process and formulation selection
  • What is a design space and how to develop one
  • Developing a Product Control Strategy

Case study

Second Day

How Do You Know You Have a Problem?

  • What formulation properties cause problems in production?
  • Early identification of problem formulations based on small data using advanced methodologies

Principles of Root Cause Analysis

  • Sources of poor compressibility and inconsistent processes
  • Impact of variations in drug substance and excipient properties

Problem Processes – How To Identify And Tackle Them.

  • Blending and segregation
  • Drying and moisture content
  • Granulation and granulation endpoint control
  • Lubrication and over blending
  • Compression and compressibility

Learning Objectives

Upon completion of the course, attendees will understand:

  • The principles of formulation design and the relationship between formulation and process
  • Appropriate formulation selection based on Target Product Profiles and Critical Quality and Material Attributes (CQAs and SMAs)
  • How to get the formulation right first time, based on pre-formulation data
  • What can go wrong with a product – trouble shooting and Root Cause Analysis
  • The types of changes which will improve a poor product and how to evaluate them