Pharmaceutical Solid-State Chemistry Throughout the Drug Development Process

Ronald Mueller
PhD. Solid State Chemistry
Director
Regis Technologies, Inc.

Members: FREE // Non-Members: $45
CLE Credit Pending

The U.S. Patents Committee and Biotech Committee present:

Ronald Mueller, Ph.D. Solid State Chemistry, Director, Regis Technologies, Inc. on Pharmaceutical Solid State Chemistry and why it is important to understand from a drug development perspective.

The rationale for salt, cocrystal, and polymorph screenings and the corresponding selection processes will be discussed. Understanding the physicochemical proprieties of the selected solid form will help ensure a successful outcome for developing a new drug. This presentation also provides the important distinctions between drug substances generically or specifically claimed in patents at a high level and why those differences are important. Organic molecules, as active pharmaceutical ingredients (APIs), have a propensity to form polymorphs, whether neutrals, salts, or cocrystals, and selecting the optimal solid form early during development will assist in (1) mitigating risks, (2) establishing robust API and drug product processes, (3) and providing for stronger regulatory and intellectual property packages.