This course can be run in-house

The Challenges and Formulation Strategies for Poorly Soluble Drug Substances

Course dates

to be advised

Venue

Duration

2 days

Cost

Many, if not most, new active pharmaceutical ingredients have very low aqueous solubility, and this will have a negative impact on their value as potential medicines.  This course is designed to describe the basic theory and to develop from there with a strategy for dealing with poorly soluble compounds.  Firstly considering salts and physical from changes (including some discussion of intellectual property and regulatory issues), then progressing to consider amorphous solid dispersion systems (their advantages, potential problems and how to make a success of such formulations), then to reflect on lipid based formulations, solubilisation approaches and self emulsifying systems.

The course is well suited to those new to the formulation of poorly soluble drugs, either with or without extensive formulation experience in other areas, as well as those working in materials characterisation and preformulation.

Who should attend

The course will suit scientists with an interest in pharmaceutical materials science, those with a desire to understanding and control material properties.  the course is well suited to formulators with the challenge of improving bioavailability of poorly soluble drug substances.  Also those with an interest in IP and regulatory issues should attend.

Course speaker

Professor Graham Buckton

Programme

Day 1

9.00 Registration and coffee

9.30       Introduction

9.45       Solubility, absorption and bioavailability – an introduction

10.45     Coffee/break

11.15     The gastro-intestinal tract in relation to drug absorption

12.15     Introduction to salts and physical form (polymorphism, size etc) to enhance drug delivery.

13.00     Lunch

14.00     Physical form continued - salt selection and survival in the GI tract,

    methods of analysis, screening approaches

15.00     Tea

15.30     Consideration of changes in physical form and the study of such changes.

             Underlying IP issues and opportunities

16.30     An introduction to amorphous products for enhanced drug delivery

17.30     Close

19.00     Course dinner

Day 2

9.00       Further discussion of  solid dispersion formulations         

10.00     Solid lipid based options for drug delivery

11.00     Coffee/break

11.30     Solubilisation and cyclodextrin inclusion complexes

12.30     Lunch

13.30     Practical approaches to selection of a formulation route

14.30     Dissolution testing and consideration of food effects etc

15.30     Tea

16.00     In vivo assessment of formulation strategies

17.00     Close