Formulating poorly water soluble drugs using ordered mesoporous silica materials is an emerging approach to tackle solubility-related bioavailability problems. The current study was conducted to assess the bioavailability-enhancing potential of ordered mesoporous silica in man. In this open-label, randomized, two-way cross-over study, 12 overnight fasted healthy volunteers received a single dose of fenofibrate formulated with ordered mesoporous silica or a marketed product based on micronized fenofibrate. Plasma concentrations of fenofibric acid, the pharmacologically active metabolite of fenofibrate, were monitored up to 96h post-dose. The rate (C/dose increased by 77%; t reduced by 0.75h) and extent of absorption (AUC/dose increased by 54%) of fenofibrate were significantly enhanced following administration of the ordered mesoporous silica based formulation. The results of this study serve as a proof of concept in man for this novel formulation approach.
Silica (SiO 2 ) is a commonly occurring compound in nature. Various crystalline and noncrystalline silica minerals of inorganic and biogenic origin are known. Depending on temperature, pressure, composition of the precursor phases, etc., several different crystalline modifications are formed. Quartz is the most abundant and well‐known polymorph. Silica occurs as meter‐sized quartz crystals or as amorphous masses made up of submicroscopic crystallites having different microstructures or growth fabrics. In addition, synthetic polymorphs have been produced for which no natural counterparts exist. In industry, quartz sand and silica rocks are widely used as raw materials for production of glass, ceramics, and silicon. Single crystals of quartz are grown artificially for application as resonator crystals in clocks, communication technology, and computer electronics. Both natural and synthetic silica powders are used as fillers to improve the mechanical properties of plastics. The article contains sections titled: 1. Silica Modifications and Products 1.1. Occurrence and Geochemistry 1.2. Si‐O Bond and Crystal Structures 1.3. Crystalline Silica Phases 1.3.1. Crystalline Silica Minerals 1.3.2. Crystalline Nonmineral Silica Phases 1.4. Noncrystalline Silica Minerals 1.5. Colored Silica Minerals 1.6. Silica Rocks 1.7. Crystalline Silica Products 1.7.1. Cultured Quartz Single Crystals 1.7.2. Polycrystalline Silica Products 1.8. Noncrystalline Silica Products 2. Quartz Raw Materials 2.1. Physical Forms and Occurrence 2.2. Processing 2.3. Uses 3. Diatomites 3.1. Introduction 3.2. Formation, Composition, and Quality Criteria 3.3. Occurrence and Mining 3.4. Processing 3.5. Analysis 3.6. Storage and Transport 3.7. Environmental and Health Protection 3.8. Uses 3.9. Recycling 4. Colloidal Silica 4.1. Introduction 4.2. Structure of Colloidal Silica Particles 4.3. Physical and Chemical Properties 4.4. Stability 4.5. Production 4.6. Analysis and Characterization 4.7. Uses 4.8. Storage, Handling, and Transportation 4.9. Economic Aspects 5. Silica Gel 5.1. Introduction 5.2. Structure, Properties, and Characterization 5.3. Production 5.4. Uses 5.5. Economic Aspects 5.6. Legal Aspects 6. Pyrogenic Silica 6.1. Flame Hydrolysis 6.1.1. Production Process 6.1.2. Morphology 6.1.3. Solid‐State Properties 6.1.4. Surface Chemistry 6.1.5. Surface Modification with Silicon Compounds 6.1.6. Characterization 6.1.7. Uses 6.1.8. Industrial Hygiene and Safety 6.2. Electric‐Arc Process 6.3. Plasma Process 7. Precipitated Silicas 7.1. Introduction 7.2. Production 7.3. Properties 7.3.1. Physicochemical Properties 7.3.2. Surface Chemistry and Surface Modification 7.3.3. Chemical Composition and Analysis 7.4. Uses 7.5. Industrial Hygiene and Safety 8. Porosils 8.1. Introduction 8.2. Physical and Chemical Properties 8.2.1. Zeosils 8.2.2. Clathrasils 8.3. Manufacture of Porosils 8.3.1. Synthesis of Porosils 8.3.2. Dealumination of Aluminosilicate Zeolites 8.3.3. Formation of Melanophlogite 9. Toxicology 9.1. Experiences with Humans 9.2. Animal Experiments
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