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8% and 18.2% prolonged median survival time comparing to those of model rats by oral and intravenous administrations, respectively. Moreover, no obvious histopathological damage to normal tissues was observed by H&E staining. Overall, DSF/HP-β-CD/Cu could be a promising intranasal formulation for the effective GBM treatment.Contact lenses may act as drug release platforms for the treatment of ocular infections, but there is still the need for extending their typical release periods and enhancing ocular bioavailability. The present study aimed to develop a molecularly imprinted silicone-based hydrogel to be used in the manufacturing of contact lenses that can be loaded efficiently and be able to release the antibiotic moxifloxacin hydrochloride (MXF) in a sustained way. A set of hydrogels was prepared by the molecular imprinting method using acrylic acid (AA) as the functional monomer for the specific recognition of MXF. The modified hydrogels loaded a higher amount of MXF, which was released for a longer time. In vitro experiments, using a microfluidic cell to mimic the ocular surface fluid turnover, showed that the imprinted hydrogel TRIS(300)-I prepared with the highest content in AA led to MXF concentrations in the release medium which were effective against S. aureus and S. epidermidis for about 2 weeks. Furthermore, some important properties such as water uptake, wettability, transmittance, ionic permeability, and Young´s modulus of the modified hydrogel remained within the range of values recommended for contact lenses. No cytotoxicity and no potential ocular irritancy effect were detected. Such hydrogel seems to be a promising alternative to the current options for the treatment of ocular infections.The aim of this study was to prepare pullulan-based orally disintegrating films (ODFs) containing amlodipine besylate, an anti-hypertensive drug, by the solvent casting method. For this purpose, nine different ODF formulations (F1-F9) were prepared by using different plasticizers (glycerol, sorbitol, propylene glycol) and different superdisintegrants (croscarmellose sodium, sodium starch glycolate, crospovidone). FD&C Green and aspartame were used as coloring agent and sweetener, respectively. According to the results of preformulation studies, the optimum ODF (F9) was determined and various characterization studies such as uniformity of mass, film thickness, surface pH of films, and mechanical properties (such as elongation at break, tensile strength, Young's modulus, and folding endurance), moisture content, disintegration time, uniformity of content and dissolution test, X-ray, DSC, SEM and short term stability analysis were performed on this formulation. Cytotoxicity and permeability studies for the F9 formulation were performed on the human epithelial colorectal adenocarcinoma (Caco-2) cell line. selleck chemicals llc The formulation F9 had appropriate morphological and mechanical properties and disintegrated within 51.3 s according to the petri dish method, and 28.8 s according to the drop method. Dissolution studies revealed that 78.1 % of amlodipine besylate was dissolved in 20 min from F9 formulation. Cell culture studies showed that the formulation had no significant toxic effect on the Caco-2 cells. Also, there was no significant difference between the Caco-2 permeabilities of amlodipine besylate powder and amlodipine besylate ODFs. As a result of all these studies, we suggest to use the pullulan based amlodipine besylate ODFs to enhance ease of administration and patient compliance.Melt granules of DI-CAFOS® A12 and 15% (w/w) Kolliphor® P407 were manufactured in a twin-screw granulator (TSG) at five different conditions (screw speed and throughput varied) and compared to granules manufactured in a high-shear granulator (HSG) (rotation speed of chopper/impeller and granulation time varied). Evaluated granules characteristics were process yield, particle-size distribution (PSD), particle morphology, flowability, porosity, specific surface area (SSA), tabletability, compressibility and binder distribution. Compared to TSG, granules produced from HSG were more spherical in shape with lower porosity, smaller mean particle size and a superior flowability. Granules made by TSG showed a more elongated structure, higher porosity and larger mean particle size with smaller SSA instead. Concerning the compression process of granules, tablets made of TSG granules exhibited a higher tabletability compared to HSG granules, whereas the compressibility remained similar. In the case of the TSG granules, energy-dispersive-X-ray (EDX) measurements of the tablet surface indicated an enhanced homogenous binder distribution. Additionally, the EDX-analyses determined that more binder was available between the individual particles, resulting in a stronger bonding.The physical stability of a prototypical pharmaceutical topical ointment, consisting primarily of an emulsion of propylene glycol droplets dispersed in a continuous white petrolatum medium, was studied with regard to droplet size growth and phase separation when the ointment undergoes heating or fluid shear. To investigate the effects of shear, the ointment at 32 °C was sheared using a transparent, narrow-gap, temperature-controlled Taylor-Couette flow apparatus operated under laminar flow conditions which provided approximately uniform shear rates. Optical methods based on microscopy were used to obtain in-situ, time-dependent propylene glycol droplet size distributions, while a wide-field lens and camera were simultaneously used to detect gross phase separation as the ointment was sheared. Microscopy was also used to observe and quantify ointment stability via analysis of droplet size evolution in the absence of fluid shear for a range of elevated temperatures. For a quiescent ointment, it was observed that the dispersed propylene glycol droplets do not exhibit any appreciable growth over a period of one month and temperatures as high as 45 °C. In contrast, fluid shear imposed at 32 °C was observed to cause rapid growth of dispersed phase droplets and the onset of large phase separated regions on time scales ranging between a few minutes to approximately half an hour for fluid strain rates ranging between 5.5 and 50 s-1, respectively. The experimental results from the lab-scale Couette flow apparatus were used to evaluate the risk of phase separation during commercial-scale manufacturing.