title: Characterization and performance assessment of solid dispersions prepared by hot melt extrusion and spray drying process.
abstract: The present study investigated effect of manufacturing methods such as hot melt extrusion (HME) and spray drying (SD) on physicochemical properties, manufacturability, physical stability and product performance of solid dispersion. Solid dispersions of compound X and PVP VA64 (1:2) when prepared by SD and HME process were amorphous by polarized light microscopy, powder X-ray diffractometry, and modulated differential scanning calorimetry analyses with a single glass transition temperature. Fourier transform infrared (FT-IR) and Raman spectroscopic analyses revealed similar molecular level interactions between compound X and PVP VA64 as evident by overlapping FT-IR and FT Raman spectra in SD and HME solid dispersions. The compactibility, tabletability, disintegration and dissolution performance were similar for solid dispersions prepared by both processing techniques. Differences in material properties such as surface area, morphological structure, powder densities, and flow characteristics were observed between SD and HME solid dispersion. The SD solid dispersion was physically less stable compared to HME solid dispersion under accelerated stability conditions. Findings from this study suggest that similar product performance could be obtained if the molecular properties of the solid dispersion processed by two different techniques are similar. However differences in material properties might affect the physical stability of the solid dispersions.
authors.affiliation: Boehringer Ingelheim Pharmaceuticals Inc., 900 Ridgebury Road, Ridgefield, CT 06877, United States. Electronic address: anjali.agrawal@boehringer-ingelheim.com.
authors.forename: Anjali M
authors.initials: AM
authors.lastname: Agrawal
authors.forename: Mayur S
authors.initials: MS
authors.lastname: Dudhedia
authors.forename: Ashwinkumar D
authors.initials: AD
authors.lastname: Patel
authors.forename: Michelle S
authors.initials: MS
authors.lastname: Raikes
mesh_terms: D003890:Desiccation; D004339:Drug Compounding / Q000379:methods*; D006358:Hot Temperature; D011759:Pyrrolidines / Q000737:chemistry; D014753:Vinyl Compounds / Q000737:chemistry
chemical_list: D011759:Pyrrolidines; D014753:Vinyl Compounds; C402301:poly(vinylpyrrolidone-co-vinyl-acetate)
keywords: Amorphous; Compactibility; Dissolution; Hot melt extrusion; Solid dispersions; Spray drying