Amorphous Solid Dispersion (Spray Drying & Hot-melt Extrusion)

Overcoming Solubility Challenges in BCS II & IV Compounds

Today, solubility challenges impact 70–90% of molecules in development, acting as the primary bottleneck for Biopharmaceutics Classification System (BCS) Class II and IV compounds. Amorphous Solid Dispersion (ASD) has become the first-line strategy for addressing these challenges, with 48+ FDA approvals spanning 2012–2023 across diverse therapeutic areas.

Crystal Pharmatech leverages the Spring & Parachute mechanism:

Spring

Converts crystalline API to high-energy amorphous form for rapid supersaturation

Parachute

Polymer matrices inhibit recrystallization, sustaining absorption window

Solubility Dynamics

To deliver these results, our two primary platforms include Spray Drying (SD) and Hot-Melt Extrusion (HME). Both methods can be utilized to prepare high-quality ASDs, dramatically enhancing solubility and oral bioavailability.

Platform 01 — Spray Drying

Spray Drying (SD)

The spray drying process is a particle engineering technique and a proven approach to improving the solubility of poorly soluble compounds.

It has been widely used to enhance bioavailability in drug manufacturing due to the following advantages:

Suitable for temperature-sensitive APIs
Scalable to commercial production
Consistent particle size control
Strong regulatory track record

Our core technical team has solid knowledge and expertise in the fundamentals and scaling-up principles for the spray drying process, having successfully commercialized several amorphous solid dispersion solid dosage form drug products. With our deep understanding of quality and regulatory requirements, alongside world-class manufacturing and analytical equipment, we support formulation development at high speed and with high quality.

Spray Drying Global Manufacturing Platform

Hot-Melt Extrusion Manufacturing Platform

Hot-Melt Extrusion Global Manufacturing Platform

Platform 02 — Hot-Melt Extrusion

Hot-Melt Extrusion (HME)

HME is widely recognized as a highly effective technology for enhancing API bioavailability, ultimately improving patient compliance and streamlining the manufacturing process.

Key advantages of HME include:

Continuous processing
No solvent exposure
Simpler downstream processing
PAT-enabled process control

Guided by rheology and engineering principles, our core team possesses a strong background in polymer science, chemistry, chemical and mechanical engineering, with deep attainments in the field of HME. We have developed robust formulation technology platforms — including both immediate release and sustained release — with a proven track record in process scale-up and commercial production.

Like our spray drying capabilities, our HME platform features world-class bench-to-production equipment and analytical instruments, ready to help innovative drug developers overcome the barriers of insoluble drugs.

Achieve Your Success with Our Expertise

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Our capabilities span three specialized platforms:

Small Molecule
Crystal Bio Solutions
Crystal NAX

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