ArticleThe AAPS journal2014
In vitro lipolysis data does not adequately predict the in vivo performance of lipid-based drug delivery systems containing fenofibrate.
Article in The AAPS journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
26 citing papers in PubMed.
- Improving In Vitro-In Vivo Correlation (IVIVC) for Lipid-Based Formulations: Overcoming Challenges and Exploring Opportunities.Pharmaceutics · 2025Review
- The Advancement of In Vitro Lipolysis: Two-Step Flow-Through Method for the Evaluation of Lipid-Based Drug Delivery Systems.Pharmaceutics · 2025Article
- Thermally-Induced Supersaturation Approach for Optimizing Drug Loading and Biopharmaceutical Properties of Supersaturated Lipid-Based Formulations: Case Studies with Ibrutinib and Enzalutamide.AAPS PharmSciTech · 2024Article
- In Situ Monitoring of Drug Precipitation from Digesting Lipid Formulations Using Low-Frequency Raman Scattering Spectroscopy.Pharmaceutics · 2023Article
- Development and optimization of sitagliptin and dapagliflozin loaded oral self-nanoemulsifying formulation against type 2 diabetes mellitus.Drug delivery · 2021Article
- Review
- Article
- Porous Nanostructure, Lipid Composition, and Degree of Drug Supersaturation Modulate In Vitro Fenofibrate Solubilization in Silica-Lipid Hybrids.Pharmaceutics · 2020Article
- Supersaturated Lipid-Based Formulations to Enhance the Oral Bioavailability of Venetoclax.Pharmaceutics · 2020Article
- Chase Dosing of Lipid Formulations to Enhance Oral Bioavailability of Nilotinib in Rats.Pharmaceutical research · 2020Article
- Suitability of Artificial Membranes in Lipolysis-Permeation Assays of Oral Lipid-Based Formulations.Pharmaceutical research · 2020Article
- Current Status of Supersaturable Self-Emulsifying Drug Delivery Systems.Pharmaceutics · 2020Review
- The effect of drug ionization on lipid-based formulations for the oral delivery of anti-psychotics.ADMET & DMPK · 2020Article
- A Proof of Concept for 3D Printing of Solid Lipid-Based Formulations of Poorly Water-Soluble Drugs to Control Formulation Dispersion Kinetics.Pharmaceutical research · 2019Article
- Lipolysis-Permeation Setup for Simultaneous Study of Digestion and Absorption in Vitro.Molecular pharmaceutics · 2019Article
- New Insights into Using Lipid Based Suspensions for 'Brick Dust' Molecules: Case Study of Nilotinib.Pharmaceutical research · 2019Article
- Exploring the utility of the Chasing Principle: influence of drug-free SNEDDS composition on solubilization of carvedilol, cinnarizine and R3040 in aqueous suspension.Acta pharmaceutica Sinica. B · 2019Article
- Impact of Drug Physicochemical Properties on Lipolysis-Triggered Drug Supersaturation and Precipitation from Lipid-Based Formulations.Molecular pharmaceutics · 2018Article
- Incorporation of lipolysis in monolayer permeability studies of lipid-based oral drug delivery systems.Drug delivery and translational research · 2018Article
- Caco-2 Cell Conditions Enabling Studies of Drug Absorption from Digestible Lipid-Based Formulations.Pharmaceutical research · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The present study investigated the utility of in vitro lipolysis performance indicators drug solubilization and maximum supersaturation ratio (SR(M)) for their predictive use for the in vivo performance in a minipig model. The commercial Lipanthyl formulation and a series of LbDDS based on identical self-nanoemulsifying drug delivery systems (SNEDDS) containing 200 mg of fenofibrate, either dissolved or suspended, were subjected to combined gastric (pH 2) and intestinal (pH 6.5) in vitro lipolysis. Based on the solubilization profiles and SRM the rank-order SNEDDS (75% drug load) > super-SNEDDS (150% drug load, dissolved) = SNEDDS suspension (150% drug load, partially suspended) > Lipanthyl was established, with an increased likelihood of drug precipitation above SR(M) > 3. The in vitro performance, however, was not reproduced in vivo in a minipig model as the mean plasma concentration over time curves of all LbDDS were comparable, independent of the initial physical state of the drug. There was no correlation between the area under the solubilization-time curves (AUC(in vitro)) of the intestinal step and the AUC(in vivo). The study suggests careful interpretation of in vitro performance criteria and revision of LbDDS optimization towards increased solubilization.
Indexed as
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.