17 co crystal 500x150 

Description

Co-crystals have generated significant interest across the pharmaceutical industry as potentially innovative solutions to real pharmaceutical problems associated with manufacturing and delivering drugs in a safe and efficacious manner. Similar to other thermodynamic forms, such as salts, polymorphs, and solvates (hydrates), co-crystals can not only be used to isolate and purify a drug substance (DS, API), but they also increase the range of solid-state options available in the search for one with physical and chemical properties that are suitable for the development of a stable commercial drug product (DP). Recognizing the importance of co-crystals, the FDA issued guidance in 2013 classifying co-crystals as drug product intermediates while the EMA issued guidance in 2014 classifying co-crystals as drug substance. Following feedback from academic groups and discussions between the IQ Consortium and the FDA, the agency has taken the lead on clarifying the issued guidance along with recommendations for regulatory filings of products involving co-crystals. A revised guidance has been issued classifying co-crystals in the same class as solvates. In the process of issuing the guidance and its revision and follow-up discussions, several intriguing scientific questions were raised among the academic and industrial groups that merit a deep analysis. Some of these include a rigorous classification system for the solid-state of drugs, complex characterization issues related to mixed salts/co-crystals and multi-API co-crystals, in-situ production of co-crystals during manufacture of drug product and biopharmaceutical implications. This workshop will highlight many of these issues in the context of the rational development of co-crystals in industry while ensuring quality of drug products containing co-crystals through incorporating a rigorous data package in world-wide regulatory filings.

Expected Outcomes

The primary goal of this workshop is to bring together the three relevant demographics that have been involved in the scientific aspects and industrial development of co-crystals as well as regulatory bodies that guide such development to discuss the state-of-the-art in the area of co-crystals in the three aspects. Specific objectives include:

  • Provide more aligned and clear direction to industry on co-crystal development, facilitating rational decision-making on options to enhance (bio)pharmaceutical properties of drug substances that lack ionizable functional groups
  • Minimize the number of scientific advice meetings sought by industry on co-crystal-related submissions
  • Allow for better harmonization of co-crystal and co-former data presentation in regulatory filings worldwide driven by science

Three primary outcomes that attendees can expect from this meeting are:

  1. Get an in-depth view of complexities associated with co-crystal development including mixed phases (co-crystals + salt), in-situ CC formulation in drug product, dissociation challenges, etc.
  2. Understand the regulatory classification of co-crystals
  3. Obtain insight into the latest research areas with regards to the design and formulation development of co-crystals
     

Who Should Attend

  • Scientists from industry that work in the solid-state, preformulation
  • Formulation and API synthesis groups
  • Academics involved in solid-state, computational aspects of crystals and crystal engineering
  • Regulators involved in reviewing filings, both NDAs and ANDAs

Sessions

  • Overview of co-crystals including biopharmaceutical aspects
  • Computational aspects of co-crystals
  • Process development of co-crystals
  • Formulation of co-crystals
  • Stability of co-crystals
  • Industrial case studies
  • Regulatory aspects of co-crystals
  • Roundtable