Day 1, Wednesday 24th June 2009
09:30 Registration and refreshments
10:00 Opening address from the chair
Dr. Anita Klute
Senior Principal Scientist
Pfizer
10:10 Impact of solid form on solubility and dissolution rate
• Relationship between bioavailability, solubility and dissolution rate
• Dependence of solubility and dissolution rate on solid form
• Possible solid forms: polymorphs, hydrates, amorphous, salts, cocrystals
• Stabilisation of the amorphous form
• Characterisation of solid forms (XRD, Raman, DSC, DVS, TG-FTIR)
Dr. Rolf Hilfiker
Vice President, Head of Department Solid-State Development
Solvias
10:50 Applications of dissolution testing and similarity function in the evaluation of compressed microcapsules/microspheres
• Significance of direct compression of of microspheres for industry
• Selection of excipients for microspheres protection
• The placebo pellets approach
• Use of dissolution testing and similarity function for the estimation of degree of damage to drug pellets
• Examples of directly compressed microspheres from the pharmaceutical industry
Dr. Idris M. El-Mahdi (Ph.D)
Associate Professor of Pharmaceutics & Dean
Arab Medical Sciences University
11:30 Morning refreshments
11:50 Developing dissolution methods for insoluble compounds - Highlighting how to overcome instability in aqueous media
• Method development strategies for BCS Class II / IV drugs
• Challenges in dissolution of compounds likely to hydrolyse in water
• Benefits of anticipating automation early in the development
Cyrille Pertuy
Director Drug Product Development - Analytical Development
Ipsen
12:30 The role of dissolution and disintegration in the early development of tablet formulations containing poorly soluble substances
• Justification for use of disintegration testing in QC testing of immediate release formulations, regardless of BCS classification
• Application of dissolution in formulation selection
• Applying ‘QbD’ philosophy to dissolution strategy for early clinical trials (up to PhIIa)
- e.g. criticality of parameters such as particle size in ensuring consistent performance in immediate release products
Dr. Anita Klute
Senior Principal Scientist
Pfizer
13:10 Networking lunch
14:30 The role of dissolution testing in building the understanding and predicting bioperformance in solid oral dosage forms
Dr. Christine Smith
Research Formulations
Pfizer
15:10 Opportunities for the Application of Quality by Design to Dissolution Strategy in Commercial Formulation Development
• Why we have a dissolution test
• Elements of QbD
• Application of QBD to the dissolution test and opportuinities for surrogacy
• Key Quality Attributes for in vitro and in vivo performance tests
• Development of QbD dissolution/ performance test strategies for IR and MR commercial formulations
• QbD performance testing post commercialisation
• Future of QbD
Kevin Ryan
Analytical R&D
Pfizer
15:50 Afternoon refreshments
16:10 Novel approach to combined dissolution and assay tests based on rapid extraction techniques
• Principles behind rapid non invasive extraction
• Systems with feedback
• How assay and dissolution might be achieved
Jon Howells
Consultant
PA Consulting
16:50 Dissolution testing of non-conventional dosage forms
• Value of dissolution testing for non-conventional dosage forms
• Delivery of drugs to the oral cavity
• Dissolution testing of chewing gum
• Release of nicotine from medicated chewing gum formulations
Dr Barbara Conway
School of Life and Health Sciences
Aston University
17:30 Closing remarks from the chair
17:35 Networking drinks
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