Conference Day One: 23rd September, 2008

08.45 Chair’s Opening Address

Characterisation of the Amorphous Form

08.55 Issues Of Amorphous State Formation And Related Instabilities

• Stability of the amorphous solid state: Out of equilibrium and doubly instable
• Control of compound with regards to physical aging and nucleation
• The relationship between preparation method and non-equilibrium state
• Amorphisation induced by dynamical perturbations and the possible prediction of the nature of the end product to manipulate the glassy state

Professor Marc Descamps
Therapeutic Materials Group
University of Lille

09.40 Physical Stabilisation Of An Amorphous Drug Substance

• Amorphous forms and the effect of on dissolution rate
• Stability issues and amorphous drug substances
• Inhibiting re-crystallisation: Understand the molecular mechanism and excipient selection
• The role of Dynamic dielectric Spectroscopy and Thermo Stimulated
• Current technique within Amorphous materials

Dr Jean Alie
Head of Solid State Laboratory
sanofi-aventis

10.55 Calorimetry As A Tool To Characterise Amorphous, Or Partly Amorphous, Compounds And Formulations

• Quantification of amorphous content
• Designing substance conditioning
• Understanding formulation behaviour

Dr Lars-Erik Briggner
Associate Principal Scientist
AstraZeneca

11.40 Practical Use Of Amorphous APIs

• Where do amorphous materials fit in drug development?
• What are the advantages and disadvantages of amorphous materials?
• Stabilisation of amorphous solids in dispersions – pros and cons
• Practical properties required for development
• Screening for solid dispersions
• Case studies of developing practical solid dispersions

Dr Stephanie Mulder
Senior Project Leader
Avantium Technologies

14.00 Formation, Stability And Control Of Amorphous Materials By Drying

• Design of freeze drying process
• Design of spray drying process
• Formulation design
• Diffusion of water within amorphous materials

Barry Aldous
Principal Scientist, Materials Science Division
Pfizer

14.45 Towards Thermodynamically Stable Amorphous Dispersions: Computational Studies Of Miscibility

• Amorphous dispersion formulations generally improve solubility but do not always solve the stability problem with amorphous materials
• Misciblity (intimate mixing) between the excipient and amorphous API is thought to stabilise the amorphous API towards crystallisation
• DSC is currently used to assess miscibility and experience shows it is not always an accurate predictor of stability
• XRPD and computational methods (Pure Curve Resolution, or PCRM) have been developed and used to assess miscibility as a complement to thermal data
• When the only Pure Reference Curves identified correspond to reference patterns of API and excipient, the system is phase separated, otherwise it is miscible
• Three model systems were studied by XRPD/ computational/ thermal methods

Dr Igor Ivanisevic
Senior Research Scientist
Aptuit

16.00 Hot Melt Processing Of Pharmaceutical Solid Dosage Forms: Opportunities For Engineering The Solid State And Drug Release Properties

The main points covered in this talk will be:

• Polymer extrusion and injection moulding for the production of bioactive solid systems
• The use of polymer extrusion and injection moulding to enhance the solubility of poorly-soluble drugs in polymer matrices
• Drug release properties of drugs from hot melt processed bioactive solid systems
• The production of multi-layered bioactive platforms using polymer extrusion technologies

Professor David Jones
Chair of Biomaterial Science
University of Belfast

16.45 Combating And Controlling The Amorphous Form

Dr Frank Thielman
Fellow in Inhalation and Device Development and Technology
Novartis

17.30 Networking Drinks Reception

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