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Consultancy
Expert Witness Pharmaceutical Training Courses

Pharmaterials have run a great many in house and open courses on physical form and formulation science subjects.

The next courses are:

Formulation for poorly soluble APIs – the theoretical basis and practical strategies

Approximately 90% of small molecule development candidates have low aqueous solubility.  The strategy for how best to formulation these should start by optimisation of physical form and conventional formulation methods, but there is plenty of scope to develop a range of other well established formulation types.

The aim of this course is to provide theoretical knowledge and practical advice on the best strategies for formulation development of poorly soluble compounds.

Course leader

The course will be run by Professor Graham Buckton.  Graham is Professor of Pharmaceutics at the School of Pharmacy, University of London, and Chief Executive Officer of Pharmaterials Ltd, a CRO with skills in (amongst other things) study and stabilisation of the amorphous form. He is the past chair of the Chemistry Pharmacy and Standards sub-committee and was a member of the Committee on Safety of Medicines, he is a British Pharmacopoeia Commissioner.  He has received a number of research awards and has published c200 papers in this field.  He is editor of the International Journal of Pharmaceutics and on a number of other editorial boards.

Programme outline

9.30 Registration and coffee

10.00 Introduction

10.15 Biopharmaceutical introduction to drug solubility and absorption

11.15 break

11.45 Solid state properties (polymorphs, salt selection, hydrates, particle size)

12.30 Lunch

13.30 Co-solvent, solubilisation and complexation

14.15 Lipid based formulations and screening concepts for selection of the best formulation method

15.00 break

15.30 Amorphous solid dispersions

16.30 Discussion

 

The popular seminar : Developing and API into an Effective Medicine will run again soon at a venue to be arranged.  - a free to attend half day seminar on Preformulation, polymorphism and formulation for poorly soluble drug substances.

for Registration details click here 

In-house Courses

Prof Graham Buckton has run many in house training sessions, either alone or with experienced colleagues, within small and large pharmaceutical companies on subjects relating to Physical Form and Formulation Development.

We would be delighted to talk with you about your training needs and to tailor an event to match your requirements.

The following course will run again in the near future, please contact us for dates.

The Amorphous State and its Significance for Product Manufacture and Drug Delivery

It is well known that amorphous materials have different properties to crystalline forms.   This can be a bad thing if the amorphous form gives rise to batch-to-batch variability in products.  Indeed small amounts of process induced amorphous content are a common cause of product and process variability.  Secondly the amorphous form can  be bad if it changes during shelf life, resulting in lower dissolution rate and possible bioavailability changes.  However if the amorphous form can be retained during shelf life there is a real advantage for poorly soluble drugs.

In this course we will study the nature of the amorphous form, how it is produced, techniques for detection and quantification, understanding of relaxation (which brings changes in properties with time), how to remove unwanted amorphous material, then how to keep wanted amorphous forms in that state and finally regulatory and IP considerations of the amorphous state.

Course leader

The course will be run by Professor Graham Buckton.  Graham is Professor of Pharmaceutics at the School of Pharmacy, University of London, and Chief Executive Officer of Pharmaterials Ltd, a CRO with skills in (amongst other things) study and stabilisation of the amorphous form. He is the past chair of the Chemistry Pharmacy and Standards sub-committee and was a member of the Committee on Safety of Medicines, he is a British Pharmacopoeia Commissioner.  He has received a number of research awards and has published c200 papers in this field.  He is editor of the International Journal of Pharmaceutics and on a number of other editorial boards.

 

9.00 Registration and coffee

9.30 Introduction

9.45 Solid state properties (polymorphs, salt selection, hydrates)

10.45 break

11.15 The amorphous state and its properties

12.00 Solid dispersion technologies

13.00 Lunch

14.00 Techniques to quantify the amorphous state and processing induced disorder

15.00 break

15.30 Patent protection and regulatory aspects of amorphous forms

16.30 Discussion

17.00 Depart

 

  

 

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