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Naji, M. |
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Motta, Antonella |
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Aletan, Dirar |
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Mohamed, Tarek |
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Ertürk, Emre |
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Taccardi, Nicola |
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Kononenko, Denys |
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Petrov, R. H. | Madrid |
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Alshaaer, Mazen | Brussels |
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Bih, L. |
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Casati, R. |
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Muller, Hermance |
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Kočí, Jan | Prague |
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Šuljagić, Marija |
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Kalteremidou, Kalliopi-Artemi | Brussels |
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Azam, Siraj |
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Ospanova, Alyiya |
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Blanpain, Bart |
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Ali, M. A. |
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Popa, V. |
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Rančić, M. |
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Ollier, Nadège |
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Azevedo, Nuno Monteiro |
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Landes, Michael |
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Rignanese, Gian-Marco |
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Tian, Yiwei
Queen's University Belfast
in Cooperation with on an Cooperation-Score of 37%
Topics
Publications (7/7 displayed)
- 2019Metformin Hydrochloride and Sitagliptin Phosphate Fixed Dose Combination Product Prepared Using Melt Granulation Continuous Processing Technologycitations
- 2019The development of an inline Raman spectroscopic analysis method as a quality control tool for hot melt extruded ramipril fixed-dose combination productscitations
- 2018A Comparative Study between Hot-Melt Extrusion and Spray-Drying for the Manufacture of Anti-Hypertension Compatible Monolithic Fixed-Dose Combination Productscitations
- 2017A new method of constructing drug-polymer temperature-composition phase diagram relevant to the hot-melt extrusion platformcitations
- 2015Probing The effects of Experimental Conditions on the Character of Drug-Polymer Phase Diagrams Constructed Using Flory-Huggins Theorycitations
- 2015Novel Supercritical Carbon Dioxide Impregnation Technique for the Production of Amorphous Solid Drug Dispersions: A Comparison to Hot Melt Extrusioncitations
- 2015An Investigation into the Role of Polymeric Carriers on Crystal Growth within Amorphous Solid Dispersion Systemscitations
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article
An Investigation into the Role of Polymeric Carriers on Crystal Growth within Amorphous Solid Dispersion Systems
Abstract
Using phase diagrams derived from Flory–Huggins theory, we defined the thermodynamic state of amorphous felodipine within three different polymeric carriers. Variation in the solubility and miscibility of felodipine within different polymeric materials (using F–H theory) has been identified and used to select the most suitable polymeric carriers for the production of amorphous drug–polymer solid dispersions. With this information, amorphous felodipine solid dispersions were manufactured using three different polymeric materials (HPMCAS-HF, Soluplus, and PVPK15) at predefined drug loadings, and the crystal growth rates of felodipine from these solid dispersions were investigated. Crystallization of amorphous felodipine was studied using Raman spectral imaging and polarized light microscopy. Using this data, we examined the correlation among several characteristics of solid dispersions to the crystal growth rate of felodipine. An exponential relationship was found to exist between drug loading and crystal growth rate. Moreover, crystal growth within all selected amorphous drug–polymer solid dispersion systems were viscosity dependent (η–ξ). The exponent, ξ, was estimated to be 1.36 at a temperature of 80 °C. Values of ξ exceeding 1 may indicate strong viscosity dependent crystal growth in the amorphous drug–polymer solid dispersion systems. We argue that the elevated exponent value (ξ > 1) is a result of drug–polymer mixing which leads to a less fragile amorphous drug–polymer solid dispersion system. All systems investigated displayed an upper critical solution temperature, and the solid–liquid boundary was always higher than the spinodal decomposition curve. Furthermore, for PVP–FD amorphous dispersions at drug loadings exceeding 0.6 volume ratio, the mechanism of phase separation within the metastable zone was found to be driven by nucleation and growth rather than liquid–liquid separation.