Precipitated silica as flow regulator

Flow regulators are added to solid pharmaceutical formulations to improve the flow properties of the powder mixtures. The primary particles of the flow regulators exist in the form of huge agglomerates which are broken down into smaller aggregates during the blending process. These smaller aggregates adsorb at the surface of the solid's grains and thus diminish attractive Van-der-Waals-forces by increasing the roughness of the host's surface. In most cases amorphous silica is used as flow additive but material properties like particle size or bond strength influence the desagglomeration tendency of the agglomerates and thus the flow regulating potency of each silica. For some silica types we will show that the differences in their flow regulating potency are due to the rate and extent by which they are able to cover the surface of the host particles. Binary powder mixtures consisting of a pharmaceutical excipient and an added flow regulator were blended in a Turbula mixer for a defined period of time. As pharmaceutical excipient corn starch was used. The flow regulators were represented by a selection of amorphous silicon dioxide types like a commercial fumed silica and various types of SIPERNAT precipitated silica provided by Evonik-Degussa GmbH, Hanau, Germany. Flowability parameters of the mixtures were characterized by means of a tensile strength tester. The reduction of tensile strength with the blending time can be correlated with an increase in fragmentation of the flow regulator.     

Synthesis of poly(sebacic anhydride)-indomethacin controlled release composites via supercritical carbon dioxide assisted impregnation

The characteristics of various pharmaceutical dosage forms are influenced by surface properties such as the friction behavior. For example, die wall friction is a key issue in developing a solid dosage form. However, the friction properties are not completely understood mainly because of the lack of fundamental measurements. Herein, the friction behavior of pharmaceutical materials was investigated and compared with their adhesion behavior using atomic force microscopy. The sliding speed causes significant variations in the frictional force. Compared with other materials, lubricant materials showed less distinct differences in friction tests than in adhesion tests, indicating the dependence of the lubricant efficiency on the stress state. The three parameters obtained from the modified Amonton's law, i.e., absolute frictional force, friction coefficient and residual force, showed consistent trends. Overall, the friction behavior was not a direct reflection of the adhesion forces. The intrinsic friction behavior of a single pharmaceutical particle can be quantified using atomic force microscopy.     

Influence of shear intensity and total shear on properties of blends and tablets of lactose and cellulose lubricated with magnesium stearate

A new technique to quantify the effects of shear intensity and total shear on the homogeneity, flowability and bulk density of a lubricated free-flowing pharmaceutical blend and on properties of resulting tablets is presented. A modified Couette cylindrical cell with uniformly spaced pins is used to create a uniform shear environment. The range of lubricant concentrations explored is 0-2% (on a mass basis). Sheared blends are used to produce tablets in the Presster (a simulator of an actual tablet press), allowing us to correlate the shear history of the blend (shear intensity and total shear) with the crushing hardness of tablets. The results show that the larger the total shear, the more homogeneous the blend. Bulk density increases with total shear until reaching a distinctive plateau. Results also indicate that high total shear affects the blend flow properties. For tablets, crushing hardness decreases as concentration of lubricant and total shear increase. Interestingly, and unexpectedly, under constant total shear, shear intensity affects the crushing hardness of tablets only slightly.     

复方肾炎片成型工艺研究

目的确定复方肾炎片成型工艺。方法采用颗粒合格率、休止角、吸湿率及可压性为考查指标,考查了复方肾炎片制粒的配方;对颗粒临界相对湿度、颗粒流动性、堆密度进行了测定;对片型片重进行了选择。结果复方肾炎片制粒的配方以药粉：可溶性淀粉：β-CD为80∶15：5为佳;颗粒临界相对湿度为65%,颗粒休止角为33.1°,颗粒堆密度为0.49g/cm3;选择了0.6g/片的异型片;确定了薄膜包衣工艺和整个成型工艺流程。结论本试验为复方肾炎片成型工艺提供了试验依据。     

Viscosity and thermal kinetics of 10 preheated restorative resin composites and effect of ultrasound energy on film thickness

ObjectiveThis study investigated viscosity and thermal kinetics of 10 selected preheated restorative resin composites and the effect of ultrasound energy on film thickness.MethodsA range of different resin composites was tested: Charisma Diamond, IPS Empress Direct, Enamel Plus HRi, Essentia, Estelite Omega, Filtek Z100, Filtek Z350 XT, Gradia, TPH Spectrum and VisCalor. A flowable resin composite (Opallis Flow) and two resin cements (RelyX Veneer, Variolink Esthetic LC) also were tested. Viscosity (Pa s) was measured at 37 °C and 69 °C (preheating temperature) using a rheometer. Film thickness (μm) was measured before and after application of ultrasound energy. Temperature loss within resin composite following preheating (°C/s) was monitored. Data were statistically analyzed (α = 0.05).ResultsViscosity at 69 °C was lower than at 37 °C for all materials except the flowable resin composite. Preheating reduced viscosity between 47% and 92% for the restorative resin composites, which were generally more viscous than the flowable materials. Film thickness varied largely among materials. All preheated resin composites had films thicker than 50 μm without ultrasound energy. Application of ultrasound reduced film thickness between 21% and 49%. Linear and nonlinear regressions did not identify any relationship between filler loading, viscosity, and/or film thickness. All materials showed quick temperature reduction following preheating, showing maximum temperature loss rates after approximately 10 s.SignificanceDistinct restorative resin composites react differently to preheating, affecting viscosity and film thickness. The overall performance of the preheating technique depends on proper material selection and use of ultrasound energy for reducing film thickness.     

Gas-pressurized dispersive powder flow tester for low volume sample characterization

The conventional powder flow testers require sample volumes larger than 40 g and are met with experimental hiccups due to powder cohesion. This study designed a gas-pressurized dispersive powder flow tester where a high velocity air is used to disaggregate powder (9 g) and eliminate its cohesion. The pressurized gas entrained solid particles leaving an orifice where the distance, surface area, width and weight of particle dispersion thereafter are determined as flow index. The flow indices of seven lactose grades with varying size, size distribution, shape, morphology, bulk and tapped densities characteristics were examined. They were compared against Hausner ratio and Carr's index parameters of the same powder mass. Both distance and surface area attributes of particle dispersion had significant negative correlations with Hausner ratio and Carr's index values of lactose. The distance, surface area and ease of particle dispersion varied proportionately with circular equivalent, surface weighted mean and volume weighted mean diameters of lactose, and inversely related to their specific surface area and elongation characteristics. Unlike insensitive Hausner ratio and Carr's index, an increase in elongation property of lactose particles was detectable through reduced powder weight loss from gas-pressurized dispersion as a result of susceptible particle blockage at orifice. The gas-pressurized dispersive tester is a useful alternative flowability measurement device for low volume and cohesive powder.