Sterilization is essential for hydrogel-based biomaterials, but it can also determine the final material state. This study used ionically crosslinked alginate hydrogels as a model system to evaluate sterilization as a coupled process linking microbial inactivation and hydrogel structural reorganization. Steam sterilization, gamma irradiation, ethylene oxide (EtO), ultraviolet (UV) irradiation, and high hydrostatic pressure (HHP) treatment were assessed within the same model system. Microbiological effectiveness was assessed using surface- and matrix-associated contamination models, while structural responses were evaluated by rheology, dimensional changes, and swelling behavior. Steam sterilization, gamma irradiation, EtO, and selected HHP conditions resulted in no detectable microbial growth under the tested conditions, whereas UV irradiation was insufficient to eliminate detectable growth from matrix-associated contamination. However, microbiologically effective treatments produced distinct material profiles. Steam generated a compact and stiff hydrogel state, gamma irradiation produced softened but deformation-tolerant networks, EtO caused pronounced dimensional alteration and high deformability, and HHP produced softened, water-accessible hydrogels with parameter-dependent responses. These findings show that sterilization method selection should integrate microbial inactivation with the final structural state required for application-specific hydrogel performance.

Predicting the processability of amorphous solid dispersions (ASDs) during hot-melt extrusion (HME) remains critical in pharmaceutical development. This study demonstrates that melt apparent viscosity data obtained from rotational rheology, combined with constitutive modeling, can be extrapolated to approximate in-process extruder torque and thereby guide formulation and process selection. Using celecoxib-PVPVA 64 as a model system, composition- and temperature-dependent melt rheology was quantified for three drug-to-polymer ratios (30/70, 50/50, 70/30 w/w) over 130 - 160°C. Steady-shear viscosity data of vacuum compression moulded ASDs were fitted to Cross and Carreau models and extrapolated to a process-relevant shear rate corresponding to 100 rpm screw speed. Extrapolated viscosities were converted into torque using screw-channel shear stress relationships, and an empirical linear calibration was applied to reconcile calculated and experimental torque under starve-fed HME conditions. Polymer-rich formulations (30/70) showed the highest apparent viscosity and torque demand, whereas drug-rich systems (70/30) exhibited lower viscosities and torque due to celecoxib plasticization, at the expense of a reduced amorphous processing window. Across most conditions, the Cross model provided superior viscosity fits and marginally better torque predictions than the Carreau model. Transparent filaments for the 30/70 and 50/50 formulations confirmed successful amorphization, whereas the 70/30 formulation yielded opalescent filaments consistent with incipient phase heterogeneity. Among the investigated formulations, the CCX/PVPVA ASD prepared at 30:70 under 150 oC showed the most favorable balance of homogeneous dispersion, solid-state amorphization, and processability, and was therefore identified as the best formulation and process setting for VCM preparation. Overall, this viscosity-to-torque framework offers a material-sparing approach to anticipate HME processability and define composition- and temperature-dependent processing windows for ASD formulations.

Sterilization-related treatments are commonly applied to hydrogel-based biomaterials, and rheological data provide a basis for describing their post-treatment material profiles. This data article presents raw oscillatory rheometry data from untreated calcium-alginate hydrogel samples and from samples exposed to ultraviolet irradiation, ethylene oxide treatment, steam sterilization, gamma irradiation, and high hydrostatic pressure treatment. The dataset was generated by amplitude sweep measurements using an Anton Paar MCR 102e rheometer with parallel-plate geometry at 37 °C. The deposited CSV files include point-by-point values for shear strain, shear stress, storage modulus, loss modulus, loss factor, torque, and complex viscosity. Corresponding plots show storage and loss moduli versus shear strain, storage and loss moduli versus shear stress, and complex viscosity versus shear strain. The files are organized by treatment group; gamma-treated samples are arranged by dose, and high hydrostatic pressure-treated samples by pressure level and number of cycles. The dataset can be reused to extract viscoelastic parameters, define the linear viscoelastic region using user-selected criteria, generate rheological profiles for untreated and treatment-exposed hydrogels, and support exploratory analysis and testing of rheological data-processing workflows.

Background/Objectives. Warfarin possesses a bitter taste and requires a personalized dose in the range of 4.5 to 77 mg per week. This study investigated the potential for personalizing warfarin dosing by developing taste-masked matrix pellets. Pellets, supposedly, can be counted and orally administered in the required quantity to obtain the required dose. Methods. The study evaluated the effects of drug load (10, 20, and 30 wt.%) on the duration of thermal postprocessing (to achieve the desired aspect ratio) and drug release. The warfarin sodium clathrate was characterized by determining its pKa value and dissolution kinetics in water, stomach-simulated media (0.1 M HCl, pH 1.2), and mouth-simulated media (phosphate-buffered solution (PBS), pH 6.8). A solid dispersion of warfarin sodium clathrate with Kollicoat^® Smartseal 100 P or Eudragit^® E PO was prepared using hot melt extrusion (HME). The mechanical properties of extruded filaments were characterized by measuring their elastic modulus. The microparticles (1–4 mm in length) prepared with filament cut pelletizing were thermally treated to produce ‘smoothened’ particles, which were analyzed with optical microscopy and drug release testing. Conclusions. Microparticles with smoothened edges and an aspect ratio close to one are expected to improve mouthfeel and potentially patient compliance. No drug release was observed in mouth-simulated media, which indicated applicability to the taste masking of the microparticles. The proposed thermal treatment of HME microparticles, exemplified in this study, is a novel concept with underexplored potential in preparing taste-masked matrix pellets and dose personalization.