Estimation of Drug Particle Size in Intact Tablets by 2-Dimensional X-Ray Diffractometry
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Thakral, Seema↗
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Switching from batch to continuous granulation: A case study of metoprolol succinate ER tablets
Continuous manufacturing (CM) has been used to produce several immediate release drug products. No extended-release (ER) product manufactured employing CM technology has been approved yet. Herein this study investigated the critical aspects of switching from the batch mode of high shear granulation to the continuous operation of twin-screw granulation for extended-release tablets. Metoprolol succinate ER tablets was used as a model ER formulation for this purpose. A central composite design (CCD) was employed to determine the effects of high shear granulator (HSG) parameters, namely impeller speed, granulation time, and binder liquid feeding rate, on the critical granulation characteristics important for product performance. These critical granulation characteristics served as a guide for switching from the batch processing to the continuous operation for achieving the same breaking strength and dissolution for this ER metoprolol tablets. The granulation time was the most critical factor affecting the bulk properties of granules which contributed to tablet dissolution. The higher density and lower compressibility of granules were attained at the longest granulation time of 5.4 min with the fastest liquid feeding rate of 75 g/min. The granules’ density was the primary factor negatively affecting the dissolution of metoprolol tablets. However, the breaking strength of tablets confounded the effect of granules density on metoprolol dissolution. Switching the processing parameters of high shear granulation to twin-screw granulation achieved similar dissolution profiles (F2 greater than 50). The screw speed was not found to affect bulk properties of granules. The root cause of granulation failures in twin-screw granulation, such as premature consolidation, excessive swelling, poor cohesion, inconsistent shearing effects, and formation of deformed agglomerates, were identified. In conclusion, the use of critical granulation characteristics through a performance-based approach of ER tablets facilitated the switching of manufacturing of an ER formulation form batch to continuous operation.
37 INORGANIC, ORGANIC, PHYSICAL, AND ANALYTICAL CH↗
A novel peridynamics-based approach to predict pharmaceutical tablet robustness
The pharmaceutical drug product development process can be greatly accelerated through the use of modeling and simulation techniques to predict the manufacturability and performance of a given formulation. The anticipation and possible mitigation of tablet damage due to manufacturing stresses represents a specific area of interest in the pharmaceutical industry for predicting formulation and tableting performance. While the finite element method (FEM) has been extensively used for predicting the mechanical behavior of powder material in the compaction processes, a shortcoming of the approach is the inherent difficulty to predict discontinuities (e.g., damage or cracking) within a tablet as FEM is a continuum-based approach. In this work, we propose a novel method utilizing peridynamics (PD), a numerical method that can capture discontinuities such as tablet fracture, to predict the evolution of damage and breakage in pharmaceutical tablets. The approach links (1) the finite element method – to elucidate the behavior of powders during die compaction – with (2) the peridynamics modeling technique – to model the discontinuous nature of damage and predict tablet breakage during the critical stages of unloading and ejection from the compression die. This short communication presents a proof of concept including a workflow to calibrate the linked FEM-PD simulation models. Further, it demonstrates promising results from a preliminary experimental validation of the approach. Following further development, this approach could be used to guide the optimization of compression processes through targeted changes to formulation material properties, compression process conditions, and/or tooling geometries to deliver improved process efficiency and tablet robustness.
36 MATERIALS SCIENCE↗
Calcification prevention tablets
Citric acid tablets, which slowly release citric acid when flushed with water, are under development by the Navy for calcification prevention. The citric acid dissolves calcium carbonate deposits and chelates the calcium. For use in urinals, a dispenser is not required because the tablets are non-toxic and safe to handle. The tablets are placed in the bottom of the urinal, and are consumed in several hundred flushes (the release rate can be tailored by adjusting the formulation). All of the ingredients are environmentally biodegradable. Mass production of the tablets on commercial tableting machines was demonstrated. The tablets are inexpensive (about 75 cents apiece). Incidences of clogged pipes and urinals were greatly decreased in long term shipboard tests. The corrosion rate of sewage collection pipe (90/10 Cu/Ni) in citric acid solution in the laboratory is several mils per year at conditions typically found in traps under the urinals. The only shipboard corrosion seen to date is of the yellow brass urinal tail pieces. While this is acceptable, the search for a nontoxic corrosion inhibitor is underway. The shelf life of the tablets is at least one year if stored at 50 percent relative humidity, and longer if stored in sealed plastic buckets.
Lindsay, Geoffrey A.↗
Highly anisotropic conductivity of tablets pressed from polyaniline-montmorillonite nanocomposite
Highlights: • Montmorillonite (MMT) can be intercalated with polyaniline (PANI) chains. • Tablets pressed from PANI/MMT exhibit high anisotropy in electrical conductivity. • Pressure 28MPa is sufficient to reach the anisotropy. • Tablets pressed from pure PANI also exhibit anisotropy in electrical conductivity. - Abstract: Polyaniline-montmorillonite nanocomposite was prepared from anilinium sulfate (precursor) and ammonium peroxodisulfate (oxidizing agent) using simple one-step method. The resulting nanocomposite obtained in powder form has been pressed into tablets using various compression pressures (28–400 MPa). Electrical conductivities of tablets in two perpendicular directions, i.e. direction parallel with the main surface of tablet (σ=) and in orthogonal direction (σ⊥), and corresponding anisotropy factors (i.e., the ratio σ=/σ⊥) have been studied in dependence on compression pressure used during the preparation. Polyaniline-montmorillonite nanocomposite was characterized using X-ray diffraction analysis, raman spectroscopy, transmission electron microscopy, thermogravimetric analysis and molecular modeling which led to the understanding of the internal structure. Measurement of hardness performed on pressed tablets has been also involved. Taking into account the highest value of anisotropy factor reached (σ=/σ⊥ = 490), present study shows a chance to design conductors with nearly two-dimensional conductivity.
36 MATERIALS SCIENCE↗
Optimization of screw design for continuous wet granulation: A case study of metoprolol succinate ER tablets
This study aimed at understanding the effect of screw design on the critical characteristics of granules and tablets of an extended-release (ER) formulation for twin screw granulation process. The screw design parameters assessed included number of kneading elements (KEs) per kneading zone, distance separating kneading zones, staggering angle (SA) of kneading elements and number of sizing elements (SEs). These input variables were varied using a design of experiment (DoE) approach to manufacture granules. Particle size distribution (PSD), flow and bulk properties of the granules, breaking strength and dissolution of tablets manufactured using these granules were characterized. The results of least square fitting showed that KEs, SA, and SEs of the screws significantly (p -values < 0.05) affected the PSD, cohesion, compressibility (CPS), conditioned bulk density (CBD) and permeability of the granules. The KEs and SEs significantly (p -value < 0.05) affected the dissolution, which was attributed to their effects on CPS and CBD of the granules. The distance between kneading zones had no significant effect on granules and tablet characteristics. Finally, these results may be used to further study the interaction of the identified critical screw design parameters with other processing parameters for continuous manufacturing of this ER matrix-based tablet formulation.
60 APPLIED LIFE SCIENCES↗
Fluid-loading solutions and plasma volume: Astro-ade and salt tablets with water
Fluid loading with salt and water is a countermeasure used after space flight to restore body fluids. However, gastrointestinal side effects have been frequently reported in persons taking similar quantities of salt and water in ground-based studies. The effectiveness of the Shuttle fluid-loading countermeasure (8 gms salt, 0.97 liters of water) was compared to Astro-ade (an isotonic electrolyte solution), to maintain plasma volume (PV) during 4.5 hrs of resting fluid restriction. Three groups of healthy men (n=6) were studied: a Control Group (no drinking), an Astro-ade Group, and a Salt Tablet Group. Changes in PV after drinking were calculated from hematocrit and hemoglobin values. Both the Salt Tablet and Astro-ade Groups maintained PV at 2-3 hours after ingestion compared to the Control Group, which had a 6 percent decline. Side effects (thirst, stomach cramping, and diarrhea) were noted in at least one subject in both the Astro-ade and Salt Tablet Groups. Nausea and vomiting were reported in one subject in the Salt Tablet Group. It was concluded that Astro-ade may be offered as an alternate fluid-loading countermeasure but further work is needed to develop a solution that is more palatable and has fewer side effects.
Fortney, Suzanne M.↗
Chocolate tablet aspects of cytherean Meshkenet Tessera
Meshkenet Tessera structures were mapped from Magellan data and several resemblances to chocolate tablet boudinage were found. The complex fault sets display polyphase tectonic sequences of a few main deformation phases. Shear and tension have contributed to the areal deformation. Main faults cut the 1600-km long Meshkenet Tessera highland into bar-like blocks which have ridge and groove pattern oriented along or at high angles to the faults. The first approach to the surface block deformation is an assumption of initial parallel shear faulting followed by a chocolate tablet boudinage. Major faults which cut Meshkenet Tessera into rectangular blocks have been active repetitively while two progressive or superposed boudinage set formations have taken place at high angles during the relaxational or flattening type deformation of the area. Chocolate tablet boudinage is caused by a layer-parallel two-dimensional extension resulting in fracturing of the competent layer. Such structures, defined by two sets of boudin neck lines at right angles to each other, have been described by a number of authors. They develop in a flattening type of bulk deformation or during superposed deformation where the rock is elongated in two dimensions parallel to the surface. This is an attempt to describe and understand the formation and development of structures of Meshkenet Tessera which has complicated fault structures.
Raitala, J.↗
Sintering of Iron Ores in a Millipot in Comparison with Tablet Testing and Industrial Process
To explore the feasibility of small-scale sintering pot testing, a ‘millipot’ facility (diameter of 53 mm and height of 400 mm) was established and used to examine the sintering performance of iron ores and other non-traditional ferrous materials. The sintering performance of a millipot was examined across a range of different operational conditions (coke rate and suction pressure) and compared with an industrial sinter strand operation. Tablet tests were also performed to assist in the design of the millipot experiments and identify conditions for achieving mineral composition similar to the industrial sinter. For the millipot experiments, the materials used need to be compacted to increase the bulk density, and a higher coke rate is required to compensate the high heat loss caused by wall effects. A higher suction pressure is also necessary to maintain an oxidizing atmosphere in the sinter bed. As expected, it was not possible to eliminate the wall effect, which resulted in more primary hematite at edges of the sintered column. However, the sintered material from the center of column simulates industrial sinter reasonably well. As such, millipot provides a practical way to evaluate the sintering process and material performance at laboratory scale, helping to bridge the gap between tablet sintering and large scale pot sintering, or full scale plant trial. The results of millipot testing can be used for designing larger scale experiments or commercial sintering trials.
36 MATERIALS SCIENCE↗
Nacre tablet thickness records formation temperature in modern and fossil shells
Nacre, the iridescent outer lining of pearls and inner lining of many mollusk shells, is made of periodic, parallel, organic sheets alternating with aragonite (CaCO 3 ) tablet layers. Nacre tablet thickness (TT) generates both nacre's iridescence and its remarkable resistance to fracture. Despite extensive studies on how nacre forms, the mechanisms controlling TT remain unknown, even though they determine the most conspicuous of nacre's characteristics, visible even to the naked eye.Thermodynamics predicts that temperature (T) will affect both physical and chemical components of biomineralized skeletons. The chemical composition of biominerals is well-established to record environmental parameters, and has therefore been extensively used in paleoclimate studies. The physical structure, however, has been hypothesized but never directly demonstrated to depend on the environment. Here we observe that the physical TT in nacre from modern and fossil shallow-water shells of the bivalves Pinna and Atrina correlates with T as measured by the carbonate clumped isotope thermometer. Based on the observed TT vs. T correlation, we anticipate that TT will be used as a paleothermometer, useful to estimate paleotemperature in shallow-water paleoenvironments. Here we successfully test the proposed new nacre TT thermometer on two Jurassic Pinna shells. The increase of TT with T is consistent with greater aragonite growth rate at higher T, and with greater metabolic rate at higher T. Thus, it reveals a complex, T-dependent biophysical mechanism for nacre formation.
36 MATERIALS SCIENCE↗
Randomized, Double-Blind, Placebo-Controlled Trial of Shuanghua Baihe Tablets to Prevent Oral Mucositis in Patients With Nasopharyngeal Cancer Undergoing Chemoradiation Therapy
Oral mucositis is a common unpreventable complication associated with chemoradiation therapy. Shuanghua Baihe tablets have been approved by the Chinese Food and Drug Administration for treating recurrent oral mucosa ulceration. This study assessed whether Shuanghua Baihe tablets could prevent oral mucositis during chemoradiation therapy for locally advanced nasopharyngeal carcinoma.
62 RADIOLOGY AND NUCLEAR MEDICINE↗
VORTAB - A data-tablet method of developing input data for the VORLAX program
A method of developing an input data file for use in the aerodynamic analysis of a complete airplane with the VORLAX computer program is described. The hardware consists of an interactive graphics terminal equipped with a graphics tablet. Software includes graphics routines from the Tektronix PLOT 10 package as well as the VORTAB program described. The user determines the size and location of each of the major panels for the aircraft before using the program. Data is entered both from the terminal keyboard and the graphics tablet. The size of the resulting data file is dependent on the complexity of the model and can vary from ten to several hundred card images. After the data are entered, two programs READB and PLOTB, are executed which plot the configuration allowing visual inspection of the model.
Denn, F. M.↗
[Determination of six main components in compound theophylline tablet by convolution curve method after prior separation by column partition chromatography]
On a partition chromatographic column in which the support is Kieselguhr and the stationary phase is sulfuric acid solution (2 mol/L), three components of compound theophylline tablet were simultaneously eluted by chloroform and three other components were simultaneously eluted by ammonia-saturated chloroform. The two mixtures were determined by computer-aided convolution curve method separately. The corresponding average recovery and relative standard deviation of the six components were as follows: 101.6, 1.46% for caffeine; 99.7, 0.10% for phenacetin; 100.9, 1.31% for phenobarbitone; 100.2, 0.81% for theophylline; 99.9, 0.81% for theobromine and 100.8, 0.48% for aminopyrine.
NASA Program Flight↗
The Virtual Tablet: Virtual Reality as a Control System
In the field of human-computer interaction, Augmented Reality (AR) and Virtual Reality (VR) have been rapidly growing areas of interest and concerted development effort thanks to both private and public research. At NASA, a number of groups have explored the possibilities afforded by AR and VR technology, among which is the IT Advanced Concepts Lab (ITACL). Within ITACL, the AVR (Augmented/Virtual Reality) Lab focuses on VR technology specifically for its use in command and control. Previous work in the AVR lab includes the Natural User Interface (NUI) project and the Virtual Control Panel (VCP) project, which created virtual three-dimensional interfaces that users could interact with while wearing a VR headset thanks to body- and hand-tracking technology. The Virtual Tablet (VT) project attempts to improve on these previous efforts by incorporating a physical surrogate which is mirrored in the virtual environment, mitigating issues with difficulty of visually determining the interface location and lack of tactile feedback discovered in the development of previous efforts. The physical surrogate takes the form of a handheld sheet of acrylic glass with several infrared-range reflective markers and a sensor package attached. Using the sensor package to track orientation and a motion-capture system to track the marker positions, a model of the surrogate is placed in the virtual environment at a position which corresponds with the real-world location relative to the user's VR Head Mounted Display (HMD). A set of control mechanisms is then projected onto the surface of the surrogate such that to the user, immersed in VR, the control interface appears to be attached to the object they are holding. The VT project was taken from an early stage where the sensor package, motion-capture system, and physical surrogate had been constructed or tested individually but not yet combined or incorporated into the virtual environment. My contribution was to combine the pieces of hardware, write software to incorporate each piece of position or orientation data into a coherent description of the object's location in space, place the virtual analogue accordingly, and project the control interface onto it, resulting in a functioning object which has both a physical and a virtual presence. Additionally, the virtual environment was enhanced with two live video feeds from cameras mounted on the robotic device being used as an example target of the virtual interface. The working VT allows users to naturally interact with a control interface with little to no training and without the issues found in previous efforts.
virtual control interface↗
simuwatt - A Tablet Based Electronic Auditing Tool
'simuwatt Energy Auditor' (TM) is a new tablet-based electronic auditing tool that is designed to dramatically reduce the time and cost to perform investment-grade audits and improve quality and consistency. The tool uses the U.S. Department of Energy's OpenStudio modeling platform and integrated Building Component Library to automate modeling and analysis. simuwatt's software-guided workflow helps users gather required data, and provides the data in a standard electronic format that is automatically converted to a baseline OpenStudio model for energy analysis. The baseline energy model is calibrated against actual monthly energy use to ASHRAE Standard 14 guidelines. Energy conservation measures from the Building Component Library are then evaluated using OpenStudio's parametric analysis capability. Automated reporting creates audit documents that describe recommended packages of energy conservation measures. The development of this tool was partially funded by the U.S. Department of Defense's Environmental Security Technology Certification Program. As part of this program, the tool is being tested at 13 buildings on 5 Department of Defense sites across the United States. Results of the first simuwatt audit tool demonstration are presented in this paper.
32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗
Maintenance Connection (MC): MC Tablet Hybrid Software Training for Sampler Inspections [Slides]
• To provide an overview of the MC Tablet Hybrid software. • To communicate changes in Work Order (WO) generation and distribution. • Provide step by step process for electronic WO data entry for sampler inspection forms.
54 ENVIRONMENTAL SCIENCES↗
Maintenance Connection (MC): MC Tablet Hybrid Software Training for BMP Inspections [Slides]
• To provide an overview of the MC Tablet Hybrid software. • To communicate the new procedure EP-DIV-SOP-20224. • To communicate changes in Work Order (WO) generation and distribution. • To provide step-by-step process for electronic WO data entry for control measure inspection forms.
54 ENVIRONMENTAL SCIENCES↗
TABLET: The personal computer of the year 2000
The University of Illinois design of the TABLET portable computer extends the freedom of pen and notepad with a machine that draws on the projected power of 21st century technology. Without assuming any new, major technological breakthroughs, it seeks to balance the promises of today's growing technologies with the changing role of computers in tomorrow's education, research, security, and commerce. It seeks to gather together in one basket the matured fruits of such buzzword technologies as LCD, GPS, CCD, WSI, and DSP. The design is simple, yet sleek. Roughly the size and weight of a notebook, the machine is a dark, featureless monolith with no moving parts. Through magneto-optics, a simple LaserCard provides exchangeable, mass data storage. Its I/O surface, in concert with built-in infrared and cellular transceivers, puts the user in touch with anyone and anything. The ensemble of these components, directed by software that can transform it into anything from a keyboard or notepad to an office or video studio, suggests an instrument of tremendous power and freedom.
Mel, Bartlett W.↗