ArticleThe AAPS journal2017
Evolution of Choice of Solubility and Dissolution Media After Two Decades of Biopharmaceutical Classification System.
Article in The AAPS journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
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.
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Who cites it
31 citing papers in PubMed, 103 citations in OpenAlex.
- Navigating Surfactant Selection in In Vitro Dissolution Testing: Mechanistic Insights and Practical Strategies.AAPS PharmSciTech · 2026Review
- Enhancement of the Solubility and Dissolution Profile of Rivaroxaban by the Antisolvent Precipitation Technique: A Promising Approach.Polymers · 2026Article
- Exploring Digestion-Induced Fed-State Simulated Intestinal Media with a Lipid Fraction and Compositional Variability.The AAPS journal · 2026Article
- Scientific and Regulatory Standards for Dissolution Similarity: a Statistical Game of Matchmaking Neither Force to Pass or Nor Fail to Pass.AAPS PharmSciTech · 2026Review
- Advancing pulmonary therapy: the role of dry powder inhalation technology in lung disease management.Naunyn-Schmiedeberg's archives of pharmacology · 2025Review
- Effects of Different Centrifugation Parameters on Equilibrium Solubility Measurements.Methods and protocols · 2025Article
- Correlation Between Dissolution Profiles of Salt-Form Drugs in Biorelevant Bicarbonate Buffer and Oral Drug Absorption: Importance of Dose/ Fluid Volume Ratio.Pharmaceutical research · 2025Article
- Advancements in Colon-Targeted Drug Delivery: A Comprehensive Review on Recent Techniques with Emphasis on Hot-Melt Extrusion and 3D Printing Technologies.AAPS PharmSciTech · 2024Review
- Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.Molecular pharmaceutics · 2024Review
- Improved Therapeutic Efficacy of MT102, a New Anti-Inflammatory Agent, via a Self-Microemulsifying Drug Delivery System, in Ulcerative Colitis Mice.Pharmaceutics · 2023Article
- Excipient Impact on Fenofibrate Equilibrium Solubility in Fasted and Fed Simulated Intestinal Fluids Assessed Using a Design of Experiment Protocol.Pharmaceutics · 2023Article
- Investigating the Effect of Basic Amino Acids and Glucosamine on the Solubility of Ibuprofen and Piroxicam.Advanced pharmaceutical bulletin · 2023Article
- Optimization of Delivery and Bioavailability of Encapsulated Caffeic Acid.Foods (Basel, Switzerland) · 2023Article
- Green Surfactants (Biosurfactants): A Petroleum-Free Substitute for Sustainability-Comparison, Applications, Market, and Future Prospects.ACS omega · 2023Review
- A Simple One-Parameter Percent Dissolved Versus Time Dissolution Equation that Accommodates Sink and Non-sink Conditions via Drug Solubility and Dissolution Volume.The AAPS journal · 2022Article
- Lipid/Clay-Based Solid Dispersion Formulation for Improving the Oral Bioavailability of Curcumin.Pharmaceutics · 2022Article
- Prediction of In Vitro Drug Dissolution into Fed-state Biorelevant Media: Contributions of Solubility Enhancement and Relatively Low Colloid Diffusivity.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2022Article
- Mucin-Protected Caco-2 Assay to Study Drug Permeation in the Presence of Complex Biorelevant Media.Pharmaceutics · 2022Article
- On the usefulness of four in vitro methods in assessing the intraluminal performance of poorly soluble, ionisable compounds in the fasted state.European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2022Article
- Fasted intestinal solubility limits and distributions applied to the biopharmaceutics and developability classification systems.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The introduction of the biopharmaceutics drug classification system (Biopharmaceutics Classification System (BCS)), in 1995, provided a simple way to describe the biopharmaceutics behavior of a drug. Solubility and permeability are among the major parameters, which determine the fraction dose absorbed of a drug substance and consequently its chances to be bioavailable. The purpose of this review is to summarize the evolution of the media used for determining solubility and dissolution and how this can be used in modern drug development. Over the years, physiologically adapted media and buffers were introduced with the intention to better predict the in vivo solubility and dissolution of drug substances. Water, buffer solutions, compendial media, micellar solubilization media, and biorelevant media are reviewed. At this time point, there is no universal medium available which can be used to predict every drug substance's solubility or a drug product's in vivo dissolution behavior. However, there have been many improvements and additions made to media to optimize their in vivo predictability; for example, the current phosphate concentrations in buffers seem to be too high to correlate with the carbonate buffer concentrations in vivo. Biorelevant media were updated to correlate them better with the composition of human intestinal fluids. The BCS was introduced into regulatory sciences as a scientific risk management tool to waive bioequivalence studies under certain conditions. Today's different guidance documents define the dose-solubility ratio differently. As shown for amoxicillin, this can cause more confusion than certainty for globally operating companies. Harmonization of BCS guidelines is highly desirable.
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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.