API co-crystals - Trends in CMC-related aspects of pharmaceutical development beyond solubility

Area of Science:

• Pharmaceutical Science
• Materials Science
• Solid-State Chemistry

Background:

• Pharmaceutical co-crystals are primarily known for improving drug solubility and dissolution.
• Their potential in enhancing pharmaceutical manufacturability remains less explored.
• This review focuses on recent advancements in co-crystal preparation and solid-state property control.

Purpose of the Study:

• To summarize recent developments in pharmaceutical co-crystal research.
• To explore new trends in co-crystal preparation and control of solid-state attributes.
• To assess potential risks associated with co-crystals in formulation processes.

Main Methods:

• Literature review of recent publications on pharmaceutical co-crystals.
• Analysis of co-crystal preparation routes and solid-state material properties.
• Evaluation of co-crystal behavior during pharmaceutical formulation.

Main Results:

• Co-crystals show promise for improving mechanical properties, including tabletability and compressibility.
• These improvements are often linked to intrinsic crystal structure properties.
• However, structural parameters of studied co-crystals may not represent approved drugs.

Conclusions:

• Pharmaceutical co-crystals offer potential benefits for drug manufacturability beyond solubility enhancement.
• Careful consideration of structural characteristics is crucial for successful co-crystal formulation.
• Further research is needed to bridge the gap between co-crystal studies and market-approved drugs.