Stability and recrystallization of amorphous solid dispersions prepared by hot-melt extrusion and spray drying
Language English Country Netherlands Media print-electronic
Document type Journal Article
PubMed
39933609
DOI
10.1016/j.ijpharm.2025.125331
PII: S0378-5173(25)00167-X
Knihovny.cz E-resources
- Keywords
- Amorphous solid dispersions, Dissolution, Hot-melt extrusion, Recrystallization, Spray drying, Stability,
- MeSH
- Hypromellose Derivatives chemistry MeSH
- Chemistry, Pharmaceutical methods MeSH
- Indomethacin * chemistry MeSH
- Crystallization * MeSH
- Povidone chemistry MeSH
- Drug Compounding methods MeSH
- Solubility * MeSH
- Spray Drying * MeSH
- Drug Stability * MeSH
- Hot Melt Extrusion Technology * methods MeSH
- Drug Liberation MeSH
- Humidity MeSH
- Hot Temperature MeSH
- Desiccation methods MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Hypromellose Derivatives MeSH
- Indomethacin * MeSH
- Povidone MeSH
Spray drying and hot-melt extrusion are among the most prevalent preparation techniques used in the pharmaceutical industry to produce amorphous solid dispersions (ASDs). This study advances previous research by integrating sample production, comprehensive analytical characterization, intrinsic dissolution rate measurements, and assessments of the behavior of ASDs under elevated temperature and humidity conditions. The study focuses on indomethacin, a widely used model for poorly soluble drugs, processed with PVP K30 or HPMC E5, both commonly used polymers. The findings demonstrate that hot-melt extruded samples exhibit superior stability against recrystallization, whereas spray dried samples achieve higher intrinsic dissolution rates. Furthermore, PVP K30 significantly outperforms HPMC E5 in the co-processing of indomethacin, enhancing both the intrinsic dissolution rate and the stability.
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