ArticleDrug delivery and translational research2014
First in man bioavailability and tolerability studies of a silica-lipid hybrid (Lipoceramic) formulation: a Phase I study with ibuprofen.
Article in Drug delivery and translational research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.
- Benefits of Applying Nanotechnologies to Hydrogels in Efficacy Tests in Osteoarthritis Models-A Systematic Review of Preclinical Studies.International journal of molecular sciences · 2022Pooled it
- Mesoporous Silica Nanoparticles in Biomedicine: Advances and Prospects.Advanced materials (Deerfield Beach, Fla.) · 2026Review
- An innovative nasal nanovaccine against SARS-CoV-2 induces systemic and upper airway immunity controlling viral replication.NPJ vaccines · 2026Article
- Enteric Coating Enhances the Biopharmaceutical Performance of a Silica-Lipid Formulation of Abiraterone Acetate.Pharmaceutics · 2025Article
- Responsive mesoporous silica nanocarriers in glioma therapy: A step forward in overcoming biological barriers.World journal of clinical oncology · 2025Review
- Applications of Tailored Mesoporous Silicate Nanomaterials in Regenerative Medicine and Theranostics.International journal of molecular sciences · 2025Review
- Polymeric nanocomposite hydrogel scaffold for jawbone regeneration: The role of rosuvastatin calcium-loaded silica nanoparticles.International journal of pharmaceutics: X · 2023Article
- Multifunctional mesoporous silica nanoparticles for biomedical applications.Signal transduction and targeted therapy · 2023Review
- Toxicity evaluation of silica nanoparticles for delivery applications.Drug delivery and translational research · 2023Review
- Mesoporous Silica Nanoparticles as a Potential Nanoplatform: Therapeutic Applications and Considerations.International journal of molecular sciences · 2023Review
- Current status of silica-based nanoparticles as therapeutics and its potential as therapies against viruses.Antiviral research · 2023Review
- Dissolution Improvement of Progesterone and Testosterone via Impregnation on Mesoporous Silica Using Supercritical Carbon Dioxide.AAPS PharmSciTech · 2022Article
- Nanoarchitectured prototypes of mesoporous silica nanoparticles for innovative biomedical applications.Journal of nanobiotechnology · 2022Review
- Enhanced Antioxidant Effects of the Anti-Inflammatory Compound Probucol When Released from Mesoporous Silica Particles.Pharmaceutics · 2022Article
- Silica-Based Stimuli-Responsive Systems for Antitumor Drug Delivery and Controlled Release.Pharmaceutics · 2022Review
- Clinical translation of silica nanoparticles.Nature reviews. Materials · 2021Article
- Impact of Magnesium Stearate Presence and Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties.The AAPS journal · 2020Article
- Supersaturated-Silica Lipid Hybrids Improve in Vitro Solubilization of Abiraterone Acetate.Pharmaceutical research · 2020Article
- Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties: Case Study-Hypromellose (HPMC).The AAPS journal · 2020Article
- Biopharmaceutical Understanding of Excipient Variability on Drug Apparent Solubility Based on Drug Physicochemical Properties. Case Study: Superdisintegrants.The AAPS journal · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinical trials addressing the viability of lipid and nanoparticle-based solid dosage forms for the oral delivery of poorly water-soluble drugs are limited to date. This Phase I study aimed to assess the comparative tolerability and oral pharmacokinetics of a novel silica nanoparticle-lipid hybrid formulation encapsulating ibuprofen (i.e., Lipoceramic-IBU) with reference to a commercial tablet (i.e., Nurofen®). The test (Lipoceramic-IBU) and reference (Nurofen®) ibuprofen formulations were characterised for physicochemical properties and in vitro solubilisation performance prior to the clinical study. A randomised, double-blinded, one-period single oral dose (20 mg ibuprofen) study was performed in 16 healthy male subjects under fasting conditions. Encapsulation of ibuprofen in a molecularly dispersed form in the Lipoceramic nanostructured silica-lipid matrices was shown to produce superior drug solubilisation in comparison to Nurofen® and the pure drug during a two-step dissolution (or solubilisation) study in aqueous buffers of pH 1.2 followed by pH 6.5. Pharmacokinetic profiles revealed an approximately 1.95-fold increased bioavailability (p=0.02) and a 1.5-fold higher maximum plasma concentration (p=0.14) for Lipoceramic-IBU with reference to Nurofen®. Review of the safety assessments, including physical examinations, clinical laboratory tests and reports of adverse events, confirmed negligible acute side effects related to the administration of blank and ibuprofen-loaded Lipoceramic formulations. This first in man study of a dry lipid and nanoparticle-based formulation successfully demonstrated the safe use and effectiveness of the nanostructured Lipoceramic microparticles in mimicking the food effects for optimising the oral absorption of poorly water-soluble compounds.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.