title: Design of spray dried ternary solid dispersions comprising itraconazole, soluplus and HPMCP: Effect of constituent compositions.
abstract: A range of 17 ternary formulations of itraconazole (ITZ), HPMCP and Soluplus have been manufactured using spray drying. These amorphous solid dispersions (ASDs) were very stable against crystallisation and ITZ was found to be amorphous in all formulations after one year at 40°C/75% RH. A number of solid state analytical techniques including PXRD, DSC, small angle X-ray scattering, FTIR and solid state NMR were used to characterise the physicochemical properties of the ASDs following processing and storage and to assess any interactions between components. Microtrac laser scattering analysis revealed a relationship between polymer levels and particle size distribution (PSD). Dissolution studies indicated that higher Soluplus content in the formulation resulted in higher concentrations of ITZ in acidic media.
authors.affiliation: Synthesis and Solid State Pharmaceutical Centre (SSPC), The BernalInstitute, University of Limerick, Ireland. Electronic address: mark.davis@ul.ie.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Davis
authors.affiliation: Synthesis and Solid State Pharmaceutical Centre (SSPC), The BernalInstitute, University of Limerick, Ireland.
authors.forename: Catherine B
authors.initials: CB
authors.lastname: Potter
authors.affiliation: School of Pharmacy, Cavanagh Pharmacy Building, NUI, Cork, Ireland.
authors.forename: Maryam
authors.initials: M
authors.lastname: Mohammadpour
authors.affiliation: Synthesis and Solid State Pharmaceutical Centre (SSPC), The BernalInstitute, University of Limerick, Ireland.
authors.forename: Ahmad B
authors.initials: AB
authors.lastname: Albadarin
authors.affiliation: Synthesis and Solid State Pharmaceutical Centre (SSPC), The BernalInstitute, University of Limerick, Ireland.
authors.forename: Gavin M
authors.initials: GM
authors.lastname: Walker
mesh_terms: D002152:Calorimetry, Differential Scanning / Q000379:methods; D002626:Chemistry, Pharmaceutical / Q000379:methods; D003460:Crystallization / Q000379:methods; D004339:Drug Compounding / Q000379:methods; D005079:Excipients / Q000737:chemistry; D017964:Itraconazole / Q000737:chemistry*; D010316:Particle Size; D011092:Polyethylene Glycols / Q000737:chemistry*; D011108:Polymers / Q000737:chemistry; D011145:Polyvinyls / Q000737:chemistry*; D012995:Solubility; D014961:X-Ray Diffraction / Q000379:methods
chemical_list: D005079:Excipients; D011108:Polymers; D011145:Polyvinyls; C572167:polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; D017964:Itraconazole; D011092:Polyethylene Glycols
keywords: Amorphous; HPMCP; Itraconazole; Soluplus; Spray drying; Ternary