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

As the demand for small molecule drugs with high bioavailability continues to grow, the development of hydrophobic new chemical entities that have very low water solubility also increasing.  Recent statistics indicate that approximately 70% of small molecules under development belong to Biopharmaceutics Classification System (BCS) II or IV poorly water-soluble drugs. 


Crystal Pharmatech utilizes advanced amorphous solid dispersion (ASD) technology to help our clients solve this low solubility issue. Our two platforms include spray drying and hot melt extrusion. Both spray drying and hot melt extrusion methods can be utilized to prepare ASD, enhancing solubility and oral bioavailability.


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Spray Drying

The spray drying process is a particle engineering technique that is a proven approach to improving the solubility of poorly soluble compounds. It has been widely used to enhance bioavailability in drug manufacturing for the following advantages:

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


Hot Melt Extrusion

HME is widely recognized as an effective technology that enhances the bioavailability of poorly soluble APIs, ultimately improving patient compliance and making the manufacturing process more efficient.

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The core team of Crystal Pharmatech has a strong background in polymer materials, chemical industry, and machinery, adhering to the guidance of rheology and engineering principles, and has deep attainments in the field of HME. We have developed formulations and technology platforms including immediate release and sustained release and have a successful experience in process scale-up and commercial production. Like spray drying, we have world-class bench-to-production process equipment and analytical instruments. We hope to help innovative drug customers overcome the barriers of insoluble drugs with HME's method.

Achieve Your Success with Our Expertise
Contact Us
bd_global@crystalpharmatech.com +1-609-604-8303
U.S
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
Canada
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303