Spray Drying
Spray drying is one of the most widely adopted technologies in the pharmaceutical industry for addressing the formulation development challenges of poorly soluble drugs. By dissolving the API and polymer matrix in a solvent system followed by atomization and drying, the API is uniformly dispersed at the molecular level within the polymer matrix, forming amorphous Spray-Dried Dispersions (SDDs) that effectively enhance drug dissolution and improve bioavailability.
ChemExpress’ spray drying platform provides an end-to-end solution, ranging from milligram/gram-scale compound screening and kilogram-scale clinical batch manufacturing to ton-scale commercial production. Leveraging extensive formulation expertise, we deliver integrated solutions from early formulation screening to process scale-up and commercialization.
Our Capability
Why Partner with ChemExpress
Extensive Project Experience
ChemExpress has successfully scaled up 40+ ASD formulation projects and supported ~20 IND CMC programs from early development to manufacturing, ensuring efficient and seamless production transition
End-to-End Development Support
Supporting products from Pre-IND through Phase III with integrated services across key stages of drug development
Uncompromising Compliance & Quality Assurance
Successful filings in China, the US, and the EU, with proven experience in passing EU QP audits and meeting international standards
Case Study
Oral Solid Dosage form IND: Solubility Enhancement of a Poorly Soluble Drug Candidate
Background: Poor solubility of APIs is a common challenge for oral solid preparations. In this case, the micronized API exhibited extremely low solubility, severely limiting its bioavailability and in vivo absorption.
Achievement: ChemExpress successfully formulated a spray dried dispersion with significant solubility enhancement. The in vitro solubility of the SDD is 70 times higher than that of the micronized API.
FAQs
Spray drying is primarily suited for BCS Class II and Class IV poorly soluble compounds, and is particularly advantageous for thermally sensitive APIs that are not compatible with high-temperature processing. For compounds with a low glass transition temperature (Tg) or poor thermal stability, spray drying is often a preferred alternative to Hot Melt Extrusion (HME).
Both technologies produce amorphous solid dispersion (ASD), but differ in processing approach: spray drying employs a solvent-based system suitable for thermally labile APIs, while HME is a solvent-free process better suited for APIs that can tolerate thermal processing and with suitable melting point. The optimal technology is selected based on a comprehensive assessment of the API's thermal stability, solubility, Tg, and polymer compatibility.
