Review of industrially recognized polymers and manufacturing processes for amorphous solid dispersion based...

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery
• Materials Science

Background:

• Advancements in drug discovery yield more poorly soluble compounds.
• Amorphous solid dispersion (ASD) is a key strategy to improve drug solubility and bioavailability.
• Limited polymer and manufacturing options are currently utilized in FDA-approved ASD products.

Purpose of the Study:

• To provide a comprehensive guide on polymers and manufacturing technologies for ASD formulation.
• To discuss mechanisms of polymer stabilization in ASDs.
• To present ASD manufacturing techniques within a Quality by Design (QbD) framework.

Main Methods:

• Review of US FDA-approved amorphous solid dispersion products.
• Analysis of polymers and their stabilization mechanisms (solution and solid-state).
• Examination of commercialized ASD manufacturing techniques, including Quality by Design (QbD).

Main Results:

• Identified a limited set of commonly used polymers and manufacturing technologies in approved ASD products.
• Detailed the mechanisms by which polymers enhance both solution-state and solid-state stability.
• Presented manufacturing processes in a Quality by Design (QbD) format.

Conclusions:

• Effective selection of polymers and manufacturing techniques is crucial for successful ASD formulation.
• This review offers insights into industrially accepted approaches for developing challenging drug formulations.
• Emerging excipients and advanced manufacturing technologies hold promise for future ASD development.