scholarly journals Integrating Elastic Tensor and PC-SAFT Modeling with Systems-Based Pharma 4.0 Simulation, to Predict Process Operations and Product Specifications of Ternary Nanocrystalline Suspensions

Pharmaceutics ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 1771
Author(s):  
Andreas Ouranidis ◽  
Christina Davidopoulou ◽  
Kyriakos Kachrimanis
Keyword(s):  
Process Parameters ◽  
Ternary Mixtures ◽  
Stability Assessment ◽  
Critical Material ◽  
Elastic Tensor ◽  
Process Implementation ◽  
Dissolution Properties ◽  
Multi Level ◽  
Level Of Understanding ◽  
Product Specifications

Comminution of BCS II APIs below the 1 μm threshold followed by solidification of the obtained nanosuspensions improves their dissolution properties. The breakage process reveals new crystal faces, thus creating altered crystal habits of improved wettability, facilitated by the adsorption of stabilizing polymers. However, process-induced transformations remain unpredictable, mirroring the current limitations of our atomistic level of understanding. Moreover, conventional equations of estimating dissolution, such as Noyes–Whitney and Nernst–Brunner, are not suitable to quantify the solubility enhancement due to the nanoparticle formation; hence, neither the complex stabilizer contribution nor the adsorption influence on the interfacial tension occurring between the water and APIs is accounted for. For such ternary mixtures, no numeric method exists to correlate the mechanical properties with the interfacial energy, capable of informing the key process parameters and the thermodynamic stability assessment of nanosuspensions. In this work, an elastic tensor analysis was performed to quantify the API stability during process implementation. Moreover, a novel thermodynamic model, described by the stabilizer-coated nanoparticle Gibbs energy anisotropic minimization, was structured to predict the material’s system solubility quantified by the application of PC-SAFT modeling. Comprehensively merging elastic tensor and PC-SAFT analysis into the systems-based Pharma 4.0 algorithm provided a validated, multi-level, built-in method capable of predicting the critical material quality attributes and corresponding key process parameters.

Freeway Slope Stability Evaluation Based on Multi-Level Fuzzy Neural Network

2012 ◽  
Vol 430-432 ◽  
pp. 1700-1703
Author(s):  
Yan Kai Wu ◽  
Xian Song Sang ◽  
Bin Niu
Keyword(s):  
Neural Network ◽  
Artificial Neural Network ◽  
Slope Stability ◽  
Basic Principle ◽  
Fuzzy Neural Network ◽  
Stability Assessment ◽  
High Slope ◽  
Fuzzy Neural ◽  
Multi Level ◽  
Artificial Neural

On the basis of introduced basic principle of fuzzy-artificial neural network, this article constructed a slope stability assessment index system with multi-level fuzzy neural network, and made detailed evaluation criterion according to the assessment characteristics of slope stability. Through introducing the basic principle of multi-level comprehensive assessment from fuzzy mathematics and artificial neural network theory, it overcomes the defect of difficult to be quantified in evaluation process of slope stability. Therefore, it can be better to deal with some uncertain problems occurred in the slope stability assessment process, and as much as possible to express all factors influencing slope stability really and objectively. We selected 20 single factor evaluation indexes to assess slope stability based on surveying the high slope stability in Mian county-Ningqiang county freeway section. It took "normal distribution model function" as a membership function to develop a program with the model of fuzzy neural network. Furthermore, we took 30 typical slope examples as training sample to conduct effectiveness test and feedback test for the program. After the precision requirement was met, we used the program to evaluate 21 high slope examples and compared the results with the ones solved by traditional mechanical methods. The coincidence degree by using two kinds of methods to assess the same slope stability is 76.2%.

Experimental Evaluation of Glob-top Materials for use in Harsh Environments

2005 ◽  
Vol 2 (4) ◽  
pp. 253-268 ◽  
Author(s):  
Mats Lindgren ◽  
Ilja Belov ◽  
Peter Leisner
Keyword(s):  
Process Parameters ◽  
Experimental Evaluation ◽  
Experimental Results ◽  
Polymer Materials ◽  
Harsh Environments ◽  
Automotive Applications ◽  
Critical Material ◽  
Material Evaluation

This article presents results of experimental evaluation of glob-top materials for multi-chip-modules (MCM) in harsh environments. Material and process tests have been performed with the purpose to find a material which would fulfill the reliability requirements for use e.g. in military or automotive applications. Seven polymer materials, i.e. four epoxies, two silicones and one polyurethane material have been selected and evaluated in the experiments. The most critical material and process parameters for glob-top have been identified and measured. Based on the experimental results, application-based scoring of studied epoxy materials has been performed. Material evaluation results have been summarized in conclusions about the most suitable glob-top material for use in harsh environments.

Mechanical Properties of Plastics Reinforced With Carbon Nanotubes

2006 ◽  
Author(s):  
Aleksandr R. Podgaets ◽  
Wubbo J. Ockels ◽  
Yuriy V. Sokolkin
Keyword(s):  
Mechanical Properties ◽  
Carbon Nanotubes ◽  
Composite Material ◽  
Polystyrene Film ◽  
Inverse Boundary ◽  
Plastic Composites ◽  
Elastic Tensor ◽  
Multi Level ◽  
Inverse Boundary Problem ◽  
Theoretical Results

This paper describes the first steps in the area of prediction mechanical properties of nanotubes-plastic composites. Multi-level approach is used in order to take into account all the known data about all levels of composite material. Effective (macroscopic) mechanical properties are produced from solution of inverse boundary problem of continuum medium mechanics with coordinate-dependent elastic tensor. Theoretical results are compared with known experiment [1] on reinforcing polystyrene film.

Low-dose capsule filling of inhalation products: Critical material attributes and process parameters

2014 ◽  
Vol 473 (1-2) ◽  
pp. 617-626 ◽  
Author(s):  
Eva Faulhammer ◽  
Marlies Fink ◽  
Marcos Llusa ◽  
Simon M. Lawrence ◽  
Stefano Biserni ◽  
...  
Keyword(s):  
Process Parameters ◽  
Low Dose ◽  
Critical Material ◽  
Critical Material Attributes

scholarly journals DEVELOPMENT, OPTIMIZATION AND EVALUATION OF PULSATILE DRUG DELIVERY CAPSULES LOADED WITH CARVEDILOL BY APPLYING QUALITY BY DESIGN

2022 ◽  
pp. 213-220
Author(s):  
BHARATH KUMAR A. ◽  
GIRENDRA KUMAR GAUTAM ◽  
SYED SALMAN B.
Keyword(s):  
Drug Delivery ◽  
Drug Delivery System ◽  
Delivery System ◽  
Process Parameters ◽  
Polymer Concentration ◽  
Air Pressure ◽  
Inlet Temperature ◽  
Critical Material ◽  
Productivity Cost ◽  
Pulsatile Drug Delivery

Objective: The purpose of this research is to find the best way for designing carvedilol pulsatile drug delivery system capsules. Methods: The research paves the way to improve the method of preparing carvedilol pulsatile drug delivery by adjusting critical material attributes (CMA) such as coating polymer concentration, critical process parameters (CPP) such as inlet temperature and atomizing air pressure, and their impact on critical quality attributes (CQA) like particle size (PS in nm), entrapment efficiency in percentage (% EE) and amount of drug delivered in percent (%ADR) at 12 h in the carvedilol pulsatile pellets filled capsules by applying the Box-Behnken design. By varying the polymer concentration and process parameters, nearly 15 formulations were created. Results: Based on the influence of CMA, CPP on CQA, the formulation CP13 was determined to be the most optimized formulation among the 15 formulations. The optimized levels of CMA were found to be-1 level of coating polymer concentration and CPP was found to be-1 level of inlet temperature, 0 level of atomizing air pressure and it optimized CQA like PS was found to be 1017.5±8.4 nm, % EE was found to be 96.8±2.8 %, % ADR at 12 h was found to be 88.4±3.4 %. Carvedilol Pulsatile drug delivery system was designed by using optimized fluidized bed coater in order to decrease the usage of attributes, decrease the productivity cost and enhance the usage of specific attributes at fixed concentration for further manufacturing scale. Conclusion: By the current results it was concluded that the optimized CMA and CPP that shown in the results are the suitable attributes for the best formulation of carvedilol pulsatile drug delivery system capsules.

scholarly journals PRELIMINARY STUDY OF INSULIN DRY POWDER FORMULATION: CRITICAL PROCESS PARAMETERS ON SPRAY-FREEZE-DRYING AND CRITICAL MATERIAL ATTRIBUTE OF TREHALOSE AND INULIN AS STABILIZER

2021 ◽  
pp. 83-88
Author(s):  
CYNTHIA MARISCA MUNTU ◽  
SILVIA SURINI ◽  
CHRISTINA AVANTI ◽  
HAYUN ◽  
WOUTER HINRICHS
Keyword(s):  
Process Parameters ◽  
Freeze Drying ◽  
Time Lag ◽  
Physicochemical Characterization ◽  
Dry Powder ◽  
Critical Material ◽  
Atomization Process ◽  
Critical Process Parameters ◽  
Spray Freeze Drying ◽  
Critical Process

Objective: The aim of this study was to obtain recommendations about critical process parameters (CPP) and optimal ratio of trehalose and inulin as critical material attribute (CMA) on insulin dry powder formulation with spray-freeze-drying (SFD) method. Methods: Inulin dry powder was formulated with the SFD method, which consisted of an atomization process and freeze-drying (FD). SFD processes were optimized in order to obtain dry powder and CPP was analyzed. All seven variations of formulas proceeded with physicochemical characterization to obtain the optimal formula. Results: In the early optimization, there was a slight time lag between the atomization process and FD; as a result, some of the powder coagulated and crystallized. Another critical parameter was that the FD process should not be interrupted for at least 50 h of FD. Dry powder proceeded with physicochemical characterization, a formula without inulin showed semicrystalline properties, while six formulas had amorphous properties due to its combination. All formulas had a spherulite shape and rough surface. Five formulas with the combination of trehalose and inulin obtained dry powders with a diameter range of 30-43 μm, moisture content below 3.5% and high encapsulation efficiency (EE). Formula with the ratio of 1:1 (F4) showed optimal properties with moisture content and EE of 2.62% and 99.68%, respectively. Conclusion: This study concluded that there were two critical process parameters in the SFD method. There should be no time lag in SFD process and FD time which should not be interrupted. The optimal ratio for trehalose and inulin was shown by F4 with ratio of 1:1.

scholarly journals A Generic Methodology to Improve the Control of Forging Process Parameters

2013 ◽  
Vol 554-557 ◽  
pp. 2138-2144 ◽  
Author(s):  
Zakaria Allam ◽  
Eric Becker ◽  
Cyrille Baudouin ◽  
Régis Bigot ◽  
Pierre Krumpipe
Keyword(s):  
Process Parameters ◽  
Systematic Approach ◽  
Rational Approach ◽  
Control Parameters ◽  
Stroke Length ◽  
The Common ◽  
Common Problems ◽  
Physical Laws ◽  
Product Specifications

One of the common problems in forging processes is the lack of key process parameters control, as well as their identification. Certain controlled parameters exist, such as temperature or stroke length, which are usually identified and controlled through a systematic approach. Their selection depends particularly on the part to produce or on customer’s constraints, rather than a rational approach. In this paper, a methodology is proposed to select the key process parameters. There are some methodologies which already exist, such as the DMAIC, which are used to determine the control parameters and their influences on the desired specifications. However, this approach has certain drawbacks. For example, the key parameters are selected by experts, which makes each case study time consuming. The aim is to develop a generic methodology to improve the manufacturing process in the forging industry. The methodology is represented as a decision support system that connects product specifications (geometry, absence of defects…) or other forging specifications (tool wear, involved energy...) to the process parameters. The latter will be able to define the key parameters, their values and their appropriate way of control. These links will be setup using the empirical rules and physical laws.

scholarly journals FAKTOR-FAKTOR YANG MEMPENGARUHI KEPATUHAN WAJIB PAJAK DALAM MELAKUKAN PEMBAYARAN PPH 21 (Orang Pribadi pada Multi Level Marketing di Surabaya)

2020 ◽  
Vol 3 (1) ◽  
pp. 51-59
Author(s):  
Yulia Setyarini ◽  
Susan Susan
Keyword(s):  
Government Spending ◽  
Primary Data ◽  
State Revenue ◽  
Multi Level ◽  
Level Of Understanding

Taxes are the main source of state revenue, one of which comes from an individual taxpayer. Taxes have a very important role to sustain development implementation and government spending. This study aims to determine the partial influence of the level of understanding of taxpayers, awareness, and tax sanctions on compliance with income taxpayer article 21 (individual taxpayer at multi level marketing in Surabaya). The research uses primary data by distributing questionnaires to individual taxpayers doing MLM work in Surabaya. The results of this study indicate that the understanding of the regulation does not partially affect taxpayer compliance because it has a significant level> 0.05 this is because the tax regulations are constantly updated resulting in a lack of understanding of taxpayers. For awareness, as well as sanctions taxation partially affect taxpayer compliance because it has a significant level <0.05.

Sign in / Sign up

Export Citation Format

Share Document