9:00am – 11:30am Workshop A: Solid Forms as a Tool for Life Cycle Extension

Screening for solid forms, such as polymorphs, salts, cocrystals, and solid dispersions, is routinely performed during development of a drug substance to find a candidate with acceptable properties for development. This screening, along with additional work carried out later in development, provides a number of solid forms with the potential to significantly improve product performance. This workshop will discuss how an alternate solid form and combinations of an alternate solid form with formulation approaches can be used to successfully improve a marketed product. Determining when to start lifecycle management for an existing product and screening for new routes of delivery or the use of other solid forms in the next generation product will be discussed. Strategies that can be used to extend the lifecycle of a drug franchise will be presented along with case studies.

What will be covered:

• An overview of solid forms and properties that can be used in lifecycle management
• Lifecycle strategies using solid forms and formulation approaches
• Strategies for lifecycle management
• Identifying the appropriate timing to initiate life cycle management
• Case studies

Why you should attend:

• Learn what solid forms can be used for lifecycle management, how to find them, and how to capitalize on what you may already have
• Discover how the properties of solid forms can be used to successfully improve a product and its performance
• Find out how solid forms and formulation approaches are combined to design better dosage forms
• Gather an understanding of strategies that can be used for lifecycle management and franchise extension for your compound
• Hear real life case studies covering a variety of products

About Your Workshop Leaders:

12:00pm – 3:00pm Workshop B: Understanding the Polymorphism and Crystallization Behavior of Pharmaceuticals

Polymorphism is the phenomenon where a compound can form different crystal structures. It is very important in many areas of industries, and people are aware of the presence of polymorphisms and the properties of the different polymorphs. Different crystalline structures have different physical properties, which can change the use of a compound. The physical properties that may differ from one polymorph to another include: solubility, density, melting point and even color. This workshop will discuss polymorphism of pharmaceuticals with an emphasis on a good understanding of polymorphism in drug development.

What will be covered:

• Introduction to the relevance of polymorphism
• Thermodynamics of polymorphism
• Characterization of polymorphs by various techniques
• Process development based on a good understanding of polymorphism
• Process analytical techniques for the desired polymorph
• Relevant industrial case studies

About your workshop Leaders:

3:00pm Registration

3:30pm – 6:00pm Workshop C: Amorphous Dispersions: Modes of Failure, Experimental Characterization, and Stability

This workshop will briefly outline our current understanding of amorphous solid dispersions. Failure modes of single phase amorphous solid dispersions will be discussed in an interactive setting. An overview of available techniques used to detect failure will be highlighted. The attendees are encouraged to scrutinize the utility and liability of each technique and offer their own techniques. Time permitting, physical stability risk assessment will be discussed.

What will be covered:

• Failure modes of dispersions including amorphous-amorphous phase separation & crystallization
• Kinetics and thermodynamics of amorphous solid dispersions
• Characterization of amorphous dispersions
• Physical stability risk assessment

Workshop Leader:

Patrick J. Marsac
Ph.D. Phase Definition & Materials Science
Merck & Co., Inc