The influence of kappa-carrageenan, gellan gum, and konjac glucomannan on the structure and physical stability of emulsified gel systems formulated with potato, soy and mung bean proteins

Organic amendments alleviate SOC loss from erosion-prone sloping farmland by enhancing physical protection and chemical stabilization.

This study aimed to develop a functional pea milk-based energy drink enriched with varying caffeine concentrations (0%, 0.05%, and 0.10%) and Hibiscus sabdariffa extract. The formulations were evaluated in terms of physicochemical, structural, and sensory attributes to assess the effects of plant-based bioactive enrichment on product stability and consumer acceptance. pH and titratable acidity analyses revealed that H. sabdariffa extract lowered pH and increased acidity due to its intrinsic organic acids, while caffeine addition had minimal impact on pH but slightly enhanced acidity at lower concentrations. Physical stability was assessed through phase separation, where the control pea milk (PM) exhibited the highest stability, while the 100C-HPM sample (with hibiscus + 0.10% caffeine) showed pronounced serum separation, indicating reduced homogeneity. Color measurements demonstrated significant changes in Lab* values due to hibiscus pigments, particularly in caffeine-enriched formulations. Particle size distribution and zeta potential analyses revealed that the 50C-HPM (with hibiscus + 0.05% caffeine) sample had the smallest particles and lowest surface charge, implying enhanced dispersion but reduced electrostatic stability. Total soluble solids increased with H. sabdariffa and low-dose caffeine but decreased at higher caffeine levels, likely due to protein–polyphenol interactions. Microscopic observations confirmed emulsion destabilization at high caffeine concentrations. Sensory evaluation highlighted that 50C-HPM was the most preferred sample in terms of flavor, mouthfeel, and overall acceptance, whereas 100C-HPM received the lowest scores due to its astringency and turbidity. Overall, the findings suggest that the addition of H. sabdariffa and moderate caffeine can enhance the nutritional and functional profile of pea milk without compromising consumer appeal.

Structural characterization, function, and mechanism in enhancing WPI emulsion of blackcurrant polysaccharides: From macroscopic emulsion stability to molecular-level interactions by experiments and simulations.

Hospital in-use evaluation of the physical, chemical and affinity stability of the antibody-drug conjugate trastuzumab deruxtecan (Enhertu®).

Psilocybin is an emerging investigational compound with therapeutic potential in neuropsychiatric disorders, creating a need for flexible and scalable dosage forms suitable for early clinical development. This study aimed to develop and evaluate psilocybin-loaded oral thin film (OTF) formulations as a dose-proportional platform for early-phase clinical use. OTFs were prepared using a solvent casting process and characterized with respect to physicochemical properties, drug loading, content uniformity, disintegration, dissolution behavior, and short-term stability. Psilocybin was fully solubilized in the aqueous phase and successfully incorporated into the polymeric film matrix. All formulations disintegrated and dissolved within 180 s. Drug loading ranged from 6.73% to 24.07%, with recovery between 89.78% and 99.56%. The maximum amorphous psilocybin loading without detectable crystallinity was 11.75%. Stability studies conducted at 25 ± 2 °C / 60 ± 5% RH and 40 ± 2 °C / 75 ± 5% RH over three months demonstrated no significant changes in film appearance or drug content. A psilocybin-loaded oral thin film formulation with acceptable short-term physical and chemical stability was successfully developed, supporting its suitability for early-phase pharmaceutical development. Owing to their inherent dose proportionality based on film size, OTFs enable flexible dose adjustment and broad dose exploration within a single bracketed stability program, supporting efficient formulation development for early-phase clinical trials. • Psilocybin-loaded oral thin films were developed and optimized using a solvent casting process and Design of Experiments. • Films showed rapid disintegration and dissolution with high psilocybin recovery. • Amorphous psilocybin loading up to ∼11.75% was achieved without detectable crystallinity. • Short-term stability was demonstrated at 25 °C / 60% RH and 40 °C / 75% RH. • Film size-based dose proportionality enables flexible dosing for early-phase clinical development.

Comparative durability of NaOH-activated and Na2SiO3-activated geopolymer for Pb solidification/stabilization under chemical attack.

Modulating the properties of tuna skin collagen-based emulsion gels by moderate hydrolysis: Physical characteristics, stability, and lycopene delivery

The impact of oil type on the physical and oxidative stability of oil-in-water nanoemulsions: A comparative study of palm, olive, soybean, and flaxseed oils

Zein/chitosan nanocomplexes loaded with polyphenols from Polygonatum cyrtonema Hua improve Pickering emulsion stability and β-carotene protection

For 50years poly(ethylene glycol) (PEG) has been regarded as the gold standard of biocompatible, hydrophilic, and stealthy nanomedicine excipients. PEG has demonstrated improved pharmacokinetic profile, improved physical stability, and reduced toxicity for a variety of therapeutic molecules. PEG and PEG derivatives are ubiquitous, present in nearly all lipid nanoparticle vaccines, oncology nanomedicines, and over a third of solid oral dosage forms. PEG is also frequently used as a stabiliser in food and PEGylated surfactants dominate in cosmetic products. However, there is a growing body of research in which PEG immunogenicity is observed not only through repeated doses of PEGylated therapeutics, but also in so-called PEG-naïve individuals who have not yet been exposed to PEGylated drugs or formulations. Due to the potential overuse of PEG and the apparent subsequent sensitization that arises in individuals, research into PEG alternatives has garnered significant attention. Poly(cyclic imino ether)s (PCIE) are a promising family of biocompatible synthetic polymers, including poly(2-oxazoline)s (POx) and poly(2-oxazine)s (POz), which have attracted significant attention due to their potential for broad functionalisation, and tuneable physicochemical properties. Hydrophilic PCIEs have been presented as PEG alternatives with the aim of providing an alternative to PEG in nanomedicine and reducing the potential for adverse events in an increasingly PEG-sensitized population. Reports of preclinical studies involving PCIE nanomedicines are growing and show promise in terms of their application in the medical field, however, instances of clinical translation for this class of nanomedicines are disproportionately few. This review discusses the general motivation for developing PEG alternatives and their potential benefits using PCIEs as an example. It encompasses a critical appraisal of the preclinical research space surrounding PCIEs, with a view to understanding the lack of a preclinical-to-clinical translation pipeline. In reviewing the development, application and translation challenges of PCIE nanomedicines, we aim to highlight the promise of these materials for the next decade of PCIE nanomedicine research.

This study investigates the effect of structural differences among six zwitterionic surfactants on the performance of lipid-based nanoemulsions. Nanoemulsions were prepared using a standardized formulation approach to minimize compositional variability, thereby isolating the influence of surfactant type. The headgroups of the zwitterionic surfactants, phosphorylcholine, carnitine, amine oxide, betaine, and sulfobetaine, were evaluated for their impact on key parameters including physical stability, cytotoxicity, mucus diffusion, and cellular uptake within the overall surfactant structure. Results revealed significant variations in nanoemulsion performance depending on the zwitterionic surfactant structure. Formulations containing the surfactant cocamidopropyl hydroxysultaine exhibited moderate cytotoxicity but demonstrated superior diffusion through porcine mucus and enhanced uptake by human cells. In contrast, n-dodecylphosphocholine-based nanoemulsions showed excellent stability across all tested biorelevant media coupled with low cytotoxicity. Lipid-based nanocarriers formulated with lauryldimethylamine oxide combined good stability in biorelevant media with high mucus diffusion and moderate cellular uptake. Lauryl betaine-based systems displayed low hemolytic and moderate cytotoxic activities, but showed limited mucus penetration and cellular uptake. This study elucidates critical differences among various zwitterionic surfactants and highlights their suitability for liquid pharmaceutical formulations in the nanoscale range.

Physics-based machine learning for enhanced drug formulation development.

Metastable phase diagram, mobility, and kinetic stability of amorphous mixtures of two mutually compatible APIs

To overcome the poor aqueous solubility limitations of Icaritin (ICT) and Piperine (PIP), which restrict their therapeutic potential, by developing a co-amorphous drug delivery system. The co-amorphous strategy presents a promising solution to enhance solubility, dissolution rate, and oral bioavailability of poorly water-soluble drug combinations, thereby improving their pharmaceutical applicability. The optimal 1:1 molar ratio of ICT-PIP was determined through in vitro anti-inflammatory evaluation and combination modeling. Molecular dynamics simulations were employed to investigate intermolecular interactions, while Powder X-Ray Diffraction (PXRD), Fourier Transform Infrared Spectroscopy (FT-IR), and Differential Scanning Calorimetry (DSC) analyses were used to confirm co-amorphous formation and characterize solid-state properties. The ICT-PIP co-amorphous system demonstrated significantly improved solubility (3.5-fold for ICT, 3.7-fold for PIP) and intrinsic dissolution rate (2.0-fold for ICT and 1.8-fold for PIP) compared to crystalline forms. PXRD confirmed complete amorphization with no detectable crystalline peaks, FT-IR revealed intermolecular hydrogen bonding interactions between ICT and PIP, and DSC showed a single glass transition temperature (Tg) at 164.6 °C, confirming single-phase amorphous system formation. Pharmacokinetic studies revealed 1.6-fold and 1.4-fold enhancements in oral bioavailability for ICT and PIP, respectively. The system maintained excellent physical stability for six months under storage conditions. This study successfully developed a stable ICT-PIP co-amorphous system with superior solubility and bioavailability characteristics, demonstrating the effectiveness of co-amorphization as a viable strategy for optimizing the delivery of poorly soluble drug combinations.

Triple antibiotic paste (TAP) is a potent intracanal medicament, but its clinical use is often hindered by preparation variability. A premixed, injectable TAP using a propylene glycol (PG) and carboxymethylcellulose (CMC) vehicle was developed to improve preparation accuracy, handling convenience, and storage stability. This study evaluated the physicochemical stability and bactericidal efficacy of this novel TAP formulation compared to the conventional PG and macrogol (MG) formulation over a 24-week storage period. TAP (10mg/mL) was prepared using ciprofloxacin, metronidazole, and minocycline in either PG + MG or PG + CMC vehicles. Formulations were evaluated immediately and after 6, 12, and 24 weeks of storage at 4°C. Physical stability was assessed by visual inspection of appearance and consistency, while chemical stability was analyzed using UV-visible spectrophotometry across wavelengths of 200-500nm. Bactericidal activity against Enterococcus faecalis was evaluated using an infected root canal model through bacterial culture and LIVE/DEAD confocal laser scanning microscopy (CLSM). Although both formulations exhibited progressive darkening and increased viscosity during storage, UV spectrophotometry confirmed that antibiotic concentrations remained stable throughout the 24-week period. No culturable bacteria were detected in any TAP-treated groups at any time point. While CLSM analysis showed a significant reduction in bacterial viability compared to controls (p < 0.05), a modest decrease in bactericidal efficacy within dentinal tubules was observed after storage. No significant differences in antimicrobial performance were found between the two formulations (p > 0.05). Both TAP/PG + MG and TAP/PG + CMC maintained chemical stability and effective bactericidal activity for up to 24 weeks. The premixed TAP/PG + CMC formulation provides a clinically practical and standardized alternative to conventional formulations without compromising long-term therapeutic efficacy.

Solar ultraviolet (UV) radiation is the primary etiological factor in the development of several cutaneous malignancies, including carcinomas. In this context, the use of sunscreen formulations usually helps to prevent and reduce UV skin damage. The aim of this work was to explore the impact of the process conditions on some relevant physicochemical properties in sunscreens with a formulation based on quercetin Pickering emulsions stabilized with ZnO particles. Four formulations were prepared by controlling the speed and homogenization time using green coffee oil as the external phase and a mixture of stabilizers, water, and polyethylene glycol as the dissolution media. The stability of the emulsified systems was analyzed in terms of time after 28 days of storage by optical microscopy and digital image analysis to determine the mean particle size. The Turbiscan Stability Index (TSI), Sun Protection Factor (SPF), rheological behavior, and antioxidant activity were also evaluated. The system with the highest physical stability, minimal changes in rheological properties, and superior stability during storage time with respect to breakage phenomena was obtained at 15,000rpm/2 min, with a SPF of ~ 40 and exhibiting one of the highest antioxidant capacities compared to other treatments. This stability was constant during the evaluation period. With these results we established the optimal conditions for the potential development of sunscreens with desirable attributes to reduce the harmful effects of UV radiation in addition to establishing the encapsulation conditions of bioactive compounds and facilitating its scale-up.

Clear thermoplastic orthodontic aligners are widely used due to their aesthetic appeal and patient comfort; however, exposure to chemically diverse intraoral environments may compromise their physical, aesthetic, and chemical stability. This study aimed to evaluate the effect of acidic, alkaline, and neutral chemical environments on weight variation, pH interaction, colour stability, and leaching behaviour of thermoplastic orthodontic aligner materials. Thirty maxillary thermoplastic orthodontic aligners representing three commercial materials (Erkodur, Duran, and Zendura) were immersed in acidic (lime juice), alkaline (ENO® solution), or neutral (artificial saliva) media for 14 days at 37°C. Assessments were performed at Day 0, Day 7, and Day 14. Weight changes, pH variation, colour stability (ΔE, CIE Lab* using ImageJ and VITA Easyshade), and leaching behaviour (UV-Visible spectrophotometry) were analysed using repeated-measures and one-way ANOVA. Aligners in acidic media exhibited the greatest weight reduction (3.410 ± 0.015g to 3.358 ± 0.025g; p < 0.001), followed by alkaline media. Colour change was highest in acidic conditions (ΔE = 3.08 ± 0.15), moderate in alkaline (1.92 ± 0.12), and minimal in neutral media (0.77 ± 0.08). Leaching absorbance was significantly higher in acidic media at Day 14 (0.083 ± 0.004 AU; p < 0.001). Oral chemical exposures significantly compromise the physicochemical and aesthetic properties of thermoplastic aligners, highlighting the need for careful material selection, patient guidance, and further in vivo studies to confirm clinical impact.

Sufentanil combined with esketamine for patient-controlled intravenous analgesia (PCIA) is an efficient options for postoperative pain control, which can result in a shortened hospital stay. However, no commercially formulated admixture of these two agents is currently available for clinical use. Furthermore, to date, no published data exist regarding the physicochemical stability of sufentanil and esketamine co-dissolved in 0.9% sodium chloride injection. The study aims to assess the stability of sufentanil and esketamine in infusion at both room temperature (25°C) and refrigerated conditions (4°C). Commercial available injectable formulations of sufentanil and esketamine were were aseptically combined and diluted with 0.9% sodium chloride injection to yield final concentrations of 1.0µg/mL sufentanil and 0.25, 0.5, or 1.0mg/mL esketamine. The resulting admixtures were stored in polyvinyl chloride (PVC) infusion bags and assessed for compatibility and stability over 14 days at 4°C and over 48h at 25°C. Stability was evaluated through visual inspection (for precipitation or discoloration), pH measurement, and quantitative analysis of drug concentrations using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). All admixtures remained physically stable-no precipitation, turbidity, or color change was observed throughout the study period. The pH values varied by less than 0.80 units across all batches and time points under both storage conditions. Both sufentanil and esketamine retained ≥ 95% of their initial concentrations at all tested time points and temperatures. Sufentanil (1.0µg/mL) combined with esketamine (0.25, 0.5, or 1.0mg/mL) in 0.9% sodium chloride injection demonstrated chemical and physical stability for up to 14 days under refrigerated storage and for up to 48h under room-temperature conditions when contained in PVC infusion bags.

To determine whether adding S-ketamine or dexmedetomidine to oxycodone affects the microbiological, physical or chemical stability of patient-controlled analgesia (PCA) solutions prepared in a hospital pharmacy. Oxycodone solution (1 mg/mL) and three oxycodone-S-ketamine mixtures (0.25, 0.50, 0.75 mg/mL) and three oxycodone-dexmedetomidine mixtures (2.5, 5.0, 10 µg/mL) were compounded under validated European Union Good Manufacturing Practice (GMP) Class A/B aseptic conditions and filled into PCA reservoirs. Reservoirs (n=42 for physicochemical studies, n=21 for sterility, n=4 for antimicrobial activity testing) were stored at 2-8°C for 28 days, then at 20-25°C for 2 days. Sterility was assessed by membrane filtration according to European Pharmacopoeia Section 2.6.1 (Ph. Eur. 2.6.1). Physical stability was evaluated by visual inspection, pH, weight and osmolality. Chemical stability was assessed using a validated high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method developed in accordance with US Food and Drug Administration (FDA) and International Conferenece on Harmonisation (ICH) Q2(R1) guidelines. All antimicrobial activity tests showed growth of the six reference strains, indicating no inhibition by the drug mixtures. All 21 sterility-test reservoirs remained free of turbidity throughout 30 days. No visual changes, precipitation or discolouration were observed. Weight loss was ≤0.3%, pH changes were within the required range of 4.5-7 and osmolality increased by <1.4% during the study. Measured oxycodone, S-ketamine and dexmedetomidine concentrations remained within ±5% of initial values, and no degradation products were detected. Oxycodone PCA solutions containing S-ketamine or dexmedetomidine remained sterile, physically stable and chemically stable for 28 days at 2-8°C followed by 2 days at room temperature at 20-25°C. These findings support the potential for extended shelf life and centralised batch preparation of opioid-adjuvant PCA reservoirs in hospital pharmacy practice.