title: Characterization of naproxen-loaded solid SMEDDSs prepared by spray drying: the effect of the polysaccharide carrier and naproxen concentration.
abstract: The purpose of this study was to prepare solid SMEDDS (sSMEDDS) particles produced by spray-drying using maltodextrin (MD), hypromellose (HPMC), and a combination of the two as a solid carrier. Naproxen (NPX) as the model drug was dissolved (at 6% concentration) or partially suspended (at 18% concentration) in a liquid SMEDDS composed of Miglyol(®) 812, Peceol™, Gelucire(®) 44/14, and Solutol(®) HS 15. Among the sSMEDDSs tested, the MD-based sSMEDDSs (with a granular, smooth-surfaced, microspherical appearance) preserved the self-microemulsifying properties of liquid SMEDDSs and exhibited dissolution profiles similar to those of liquid SMEDDSs, irrespective of the concentration of NPX. In contrast, HPMC-based sSMEDDSs (irregular-shaped microparticles) exhibited slightly prolonged release times due to the polymeric nature of the carrier. Differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), and Raman mapping analysis confirmed molecularly dissolved NPX (at 6% of drug loading), whereas at 18% NPX loading drug is partially molecularly dissolved and partially in the crystalline state.
authors.affiliation: Krka, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenia.
authors.forename: Katja
authors.initials: K
authors.lastname: Čerpnjak
authors.affiliation: Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia.
authors.forename: Alenka
authors.initials: A
authors.lastname: Zvonar
authors.affiliation: Krka, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenia; Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia.
authors.forename: Franc
authors.initials: F
authors.lastname: Vrečer
authors.affiliation: Faculty of Pharmacy, University of Ljubljana, Aškerčeva 7, 1000 Ljubljana, Slovenia. Electronic address: Mirjana.Gasperlin@ffa.uni-lj.si.
authors.forename: Mirjana
authors.initials: M
authors.lastname: Gašperlin
mesh_terms: D000336:Aerosols; D002152:Calorimetry, Differential Scanning; D002626:Chemistry, Pharmaceutical; D003460:Crystallization; D018360:Crystallography, X-Ray; D003890:Desiccation; D004337:Drug Carriers; D004655:Emulsions; D065347:Hypromellose Derivatives / Q000737:chemistry*; D007700:Kinetics; D008855:Microscopy, Electron, Scanning; D009288:Naproxen / Q000737:chemistry*; D009829:Oleic Acids / Q000737:chemistry; D010316:Particle Size; D011092:Polyethylene Glycols / Q000737:chemistry; D011134:Polysaccharides / Q000737:chemistry*; D033362:Powder Diffraction; D012995:Solubility; D013059:Spectrum Analysis, Raman; D013229:Stearic Acids / Q000737:chemistry; D013499:Surface Properties; D013678:Technology, Pharmaceutical / Q000379:methods*; D014280:Triglycerides / Q000737:chemistry
chemical_list: D000336:Aerosols; D004337:Drug Carriers; D004655:Emulsions; D009829:Oleic Acids; C482692:Peceol; D011134:Polysaccharides; D013229:Stearic Acids; D014280:Triglycerides; C104509:gelucire 44-14; C022834:miglyol 812; D065347:Hypromellose Derivatives; D011092:Polyethylene Glycols; D009288:Naproxen; C067028:Solutol HS 15; C008315:maltodextrin
keywords: DSC; Dissolution profile improvement; Microcapsules; Raman mapping; SEM; XRPD