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Pharmacology, Toxicology and Pharmaceutics · Research topic

Open research questions in Drug Solubulity and Delivery Systems

462 gap statements mined from Drug Solubulity and Delivery Systems papers in our 7.9M-paper local library, which holds 1,970 papers on the topic — drawn mostly from each paper's own stated research gap, future-work, challenge and limitation notes, and its abstract. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one.

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What the literature leaves open

  • At the regulatory level, global regulatory consensus has not yet been formed; only the U.S. FDA has issued a dedicated draft guidance, and there is a lack of a unified framework for model validation standards, acceptance thresholds, and submission specifications.

    From Empirical Correlation to Mechanistic Modeling: The Changing Landscape of IVIVC Approaches for Oral Modified-Release Drug Products · 2026 · DOI

  • Although the API and dose are the same in all four generics, the formulations differ, where only the qualitative components are reported by the manufacturers, while other factors like excipient quantities and manufacturing process parameters remain unknown.

    A Biopredictive Fed-State Dissolution Method Incorporating High-Viscosity Media and Hydrodynamic Stress · 2026 · DOI

  • Tegoprazan has low aqueous solubility, leading to dissolution-rate-limited oral absorption. Prior formulations have not adequately addressed this issue.

    Engineering a Stable Tegoprazan Nanosuspension System for Enhanced Dissolution and Oral Bioavailability · 2026 · DOI

  • These modifications address limitations such as poor aqueous solubility and low complexation specificity and introduce advanced functionalities like pH responsiveness and polymer compatibility.

    Cyclodextrins as Multifunctional Platforms in Drug Delivery and Beyond: Structural Features, Functional Applications, and Future Trends · 2025 · DOI

  • To fully unlock the potential of natural polymers in ASD systems, several scientific gaps must be addressed through future research.

    Biocompatible Natural Polymer-Based Amorphous Solid Dispersion System Improving Drug Physicochemical Properties, Stability, and Efficacy · 2025 · DOI

  • Detection technologies also have shortcomings: inhibitors for studying endocytic pathways often lack specificity; current imaging technologies have insufficient spatial resolution to distinguish individual nanoparticles on cell membranes and poor temporal resolution to capture rapid events, leaving gaps in understanding how nano-formulations cross epithelial barriers.

    Advances and challenges in research methods on oral absorption mechanisms of nano-formulations · 2025 · DOI

  • Self-emulsifying drug delivery systems (SEDDS) have revolutionized the field of drug delivery by addressing the critical challenges of solubility and bioavailability in poorly water-soluble drugs. This review has comprehensively covered the multifaceted aspects of SEDDS, including their fundamental principles, formulation strategies, characterization techniques, and wide-ranging therapeutic applications.

    Self-Emulsifying Drug Delivery Systems (SEDDS): Transition from Liquid to Solid—A Comprehensive Review of Formulation, Characterization, Applications, and Future Trends · 2025 · DOI

  • To translate optimized formulations into clinical and commercial success, further research is essential in the post-formulation stages. Key areas include formulation validation under physiologically relevant conditions, scale-up manufacturing, long-term stability assessment, and comprehensive preclinical and clinical evaluations to confirm safety and efficacy.

    Quality by Design and In Silico Approach in SNEDDS Development: A Comprehensive Formulation Framework · 2025 · DOI

  • The integration of surfactant systems with particle engineering techniques offers a compelling multidimensional strategy for overcoming long-standing challenges in oral and systemic drug delivery.

    Surfactant–Particle Engineering Hybrids: Emerging Strategies for Enhancing Solubility and Oral Bioavailability of Poorly Water-Soluble Drugs · 2025 · DOI

  • Further research that emphasizes on comparison between different types of preparation methods to obtain more obvious information that assists in the construction of scientific guidelines for the selection of preparation methods will be required.

    Cutting-Edge Approaches in the Co-Amorphization Process · 2025 · DOI

  • Future research could focus on developing and optimizing HME formulations, including in vitro characterization, such as dissolution, mucoadhesion, and mechanical performance tests, to support their potential applications.

    Application of Theoretical Solubility Calculations and Thermal and Spectroscopic Measurements to Guide the Processing of Triamcinolone Acetonide by Hot-Melt Extrusion · 2025 · DOI

  • Future research should focus on incorporating active pharmaceutical ingredients (APIs) to evaluate how geometry influences active drug release mechanisms. The findings demonstrate that while the surface area and S/V are critical factors for simple geometries, they are insufficient to fully predict the dissolution behaviour of complex shapes.

    Effect of Geometry on the Dissolution Behaviour of Complex Additively Manufactured Tablets · 2025 · DOI

  • The insufficient comprehension of the mechanisms governing drug release and absorption in vivo limits the application of ASDs in drug development. The low aqueous solubility of plant extracts and their poor oral bioavailability limit clinical advancements due to drug delivery problems.

    Advancing the Physicochemical Properties and Therapeutic Potential of Plant Extracts Through Amorphous Solid Dispersion Systems · 2024 · DOI

  • Mesoporous carriers do not demonstrate satisfactory inhibitory effects on the precipitation of active pharmaceutical ingredients. The need for an appropriate polymer within ASDs to maintain drug supersaturation.

    Evaluation of Suitable Polymeric Matrix/Carriers during Loading of Poorly Water Soluble Drugs onto Mesoporous Silica: Physical Stability and In Vitro Supersaturation · 2024 · DOI

  • Convincing evidence for enhanced systemic vitamin bioavailability attributable specifically to cyclodextrin complexation remains scarce, and clinically validated benefits have not been established for the systems considered in this review.

    Cyclodextrin Interactions with Water-Soluble Vitamins: Biological Relevance, Stability, Delivery, and Translational Implications—A Critical Review · 2026 · DOI

  • Although the developed model demonstrated excellent predictive performance within the design space studied, its generalizability remains limited by the size and diversity of the experimental dataset.

    Building Artificial Neural Networks for the Optimization of Sustained-Release Kinetics of Metronidazole from Colonic Hydrophilic Matrices · 2025 · DOI

  • Together, they provide a transparent and scientifically grounded framework for decision-making when empirical data are limited.

    Dual Solid-State PBPK Modelling to Assess the Bio(in)equivalence of Tacrolimus Amorphous Formulations with Storage-Induced Crystallisation: A Potential Application of Virtual Bioequivalence · 2026 · DOI

  • The current investigation was focused on the development of MTZ based SEDDS formulation for enhancing the aqueous solubility and oral bioavailability of MTZ. To begin with, various oils, surfactants and co-surfactants were chosen to evaluate the solubility of MTZ wherein, Peceol™ demonstrated the highest solubility (45.87 ± 2.31 mg/mL) hence, was chosen as the oil phase.

    Fabrication and Evaluation of Self-Nanoemulsifying System of Mirtazapine: Enhanced Release Across Physiological pH Conditions with Improved Pharmacokinetics · 2026 · DOI

  • Future advancements are expected as the development of tailored drug delivery systems incorporating cyclodextrins will allow for more precise and individualized treatments. Advances in nanotechnology and molecular biology will enable the design of cyclodextrin-based carriers that selectively target diseased tissues, reducing systemic side effects and enhancing therapeutic outcomes.

    Cyclodextrins: Enhancing Drug Delivery, Solubility and Bioavailability for Modern Therapeutics · 2025 · DOI

  • The most likely reason for this is the difference in the particle sizes of the IBP crystals, as absorption of poorly soluble drugs can be limited by the dissolution rate if the particle size is too large.

    Roles of Supersaturation and Liquid–Liquid Phase Separation for Enhanced Oral Absorption of Poorly Soluble Drugs from Amorphous Solid Dispersions · 2025 · DOI

  • The future of cyclodextrin (CD) research and applications is poised to expand significantly as new advancements in chemistry, biotechnology, and material science continue to emerge. The unique properties of CDs, coupled with the growing ability to design and synthesize novel derivatives, offer tremendous opportunities for innovation across various fields.

    Cyclodextrins: Advances in Chemistry, Toxicology, and Multifaceted Applications · 2024 · DOI

  • Investigating the long-term effects of TPZ NS, - Comparing TPZ NS to other formulation strategies, - Evaluating the efficacy of TPZ NS in human clinical…

    Engineering a Stable Tegoprazan Nanosuspension System for Enhanced Dissolution and Oral Bioavailability · 2026 · DOI

  • Inclusion complexes of cyclodextrins with secondary metabolites (CDs-SMs) still present many challenges.

    Advancements in Cyclodextrin Complexes with Bioactive Secondary Metabolites and Their Pharmaceutical Applications · 2025 · DOI

  • Additional investigation of the influence of colloidal formation on drug absorption is required, - Further research on the effects of drug-polymer interactions on dissolution performance, - Investigation of the mechanisms governing drug release and absorption…

    Advancing the Physicochemical Properties and Therapeutic Potential of Plant Extracts Through Amorphous Solid Dispersion Systems · 2024 · DOI

  • We therefore regard the reduced extrapolation performance for disintegration time as an important limitation of the present study.

    Application of AI in Tablet Development: An Integrated Machine Learning Framework for Pre-Formulation Property Prediction · 2026 · DOI

Most-cited papers in Drug Solubulity and Delivery Systems

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Open questions raised by papers listed on this page include: (1) To translate optimized formulations into clinical and commercial success, further research is essential in the post-formulation stages (“Quality by Design and In Silico Approach in SNEDDS Development: A Comprehensive…”, 2025); (2) Future research could focus on developing and optimizing HME formulations, including in vitro characterization, such as dissolution, mucoadhesion, and mechanical performance tests, to support their potential applications (“Application of Theoretical Solubility Calculations and Thermal and…”, 2025); (3) Future research should focus on incorporating active pharmaceutical ingredients (APIs) to evaluate how geometry influences active drug release mechanisms (“Effect of Geometry on the Dissolution Behaviour of Complex Additively…”, 2025); (4) Although the developed model demonstrated excellent predictive performance within the design space studied, its generalizability remains limited by the size and diversity of the experimental dataset (“Building Artificial Neural Networks for the Optimization of Sustained-Release…”, 2025). 462 gap statements have been mined from Drug Solubulity and Delivery Systems papers in our 7.9M-paper local library, which holds 1,970 papers on the topic; the gaps come from whichever of those papers state one. They are mostly the research gaps the authors state and the papers' abstracts, plus future-work, limitations and challenges passages. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one, so you can read the original claim in context.

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