scholarly journals Implementation of the Quality by Design approach for developing the composition and the manufacturing technology of an injectable drug for intra-articular introduction

2021 ◽  
pp. 28-37
Author(s):  
O. Saliy ◽  
O. Los ◽  
T. Palchevska ◽  
K. Nebylytsia
Keyword(s):  
Quality Indicators ◽  
Quality By Design ◽  
Experimental Studies ◽  
Active Pharmaceutical Ingredient ◽  
Number System ◽  
Manufacturing Technology ◽  
Solution Temperature ◽  
Critical Material ◽  
Factors Affecting ◽  
Injectable Drug

Aim. To implement the Quality by Design (QbD) approach in order to develop the composition and the manufacturing technology of injectable hyaluronate sodium (HS) in combination with chondroitin sulfate (CS) for intra-articularintroduction. Materials and methods. The composition of the solution for injection was developed using samples of the active pharmaceutical ingredient (API) of HS and CS. The approaches of the ICH international guidelines were used to create the QbD protocol. The quality target product profile (QTPP) was developed based on the literature review, analysis of similar drugs and the previous in-house experimental studies. Determination of critical quality assessment (CQA) product indicators was performed by risk analysis for all quality indicators listed in QTPP. The risk assessment of quality indicators was performed by assessing them according to the Risk Priority Number system (hereinafter – RPN) by a 9-point scale. When studying the composition and the manufacturing technology of the injectable solution the quality risk management (QRM) was developed according to the Ishikawa diagram. Results and discussion. It has been found that the QbD concept is a systematic approach to the drug development. At the first stage QTPP was developed. Based on the QTPP data the CQA indicators were determined, and quality risks were assessed. The critical process parameters (CPP) of the solution for injection based on HS and CS, their control methods, as well as the critical material attributes (CMA) were determined. Based on the data obtained the drug control strategy was proposed taking into account the need to minimize the repetition of control experiments. Using the Isikawa diagram the variability of the material and the process with the environmental factors affecting the qualityof the solution for injection with HS and CS was shown.Conclusions. Using the basic QbD approaches when developing the composition and the manufacturing technology of an injectable drug for intra-articular introduction it has been found that the route of administration, dose, potency, and consumer properties of the product are important aspects of QTPP. It has been proven that the quality indicators, such as transparency, viscosity, sterility and the quantitative content of API are determined as CQA to achieve the objectives defined in QTPP. The study shows that almost all stages of production are critical, therefore, they need to be constantly monitored and checked to obtain a quality product. In further experimental studies to confirm the composition developed and the manufacturing technology according to QRM it is necessary to focus on such indicators as the solution temperature, stabilization time, degassing mode and filtration conditions.

Quality by Design in Action 2: Controlling Critical Material Attributes during the Synthesis of an Active Pharmaceutical Ingredient

2015 ◽  
Vol 19 (11) ◽  
pp. 1645-1654 ◽  
Author(s):  
Abdul Qayum Mohammed ◽  
Phani Kiran Sunkari ◽  
Amjad Basha Mohammed ◽  
P. Srinivas ◽  
Amrendra Kumar Roy
Keyword(s):  
Quality By Design ◽  
Active Pharmaceutical Ingredient ◽  
Critical Material ◽  
Critical Material Attributes

DIESEL ENGINE OPERATION IN USE OF FUEL WITH ADDITIVES

2018 ◽  
pp. 18-24
Author(s):  
Petar Kazakov ◽  
Atanas Iliev ◽  
Emil Marinov
Keyword(s):  
Diesel Engine ◽  
Fuel Consumption ◽  
Diesel Fuel ◽  
Internal Combustion Engines ◽  
Experimental Studies ◽  
Combustion Engines ◽  
Engine Operation ◽  
Factors Affecting ◽  
Operating Modes ◽  
Positive Effects

Over the decades, more attention has been paid to emissions from the means of transport and the use of different fuels and combustion fuels for the operation of internal combustion engines than on fuel consumption. This, in turn, enables research into products that are said to reduce fuel consumption. The report summarizes four studies of fuel-related innovation products. The studies covered by this report are conducted with diesel fuel and usually contain diesel fuel and three additives for it. Manufacturers of additives are based on already existing studies showing a 10-30% reduction in fuel consumption. Comparative experimental studies related to the use of commercially available diesel fuel with and without the use of additives have been performed in laboratory conditions. The studies were carried out on a stationary diesel engine СМД-17КН equipped with brake КИ1368В. Repeated results were recorded, but they did not confirm the significant positive effect of additives on specific fuel consumption. In some cases, the factors affecting errors in this type of research on the effectiveness of fuel additives for commercial purposes are considered. The reasons for the positive effects of such use of additives in certain engine operating modes are also clarified.

ADOLESCENTS IN CRIMINAL STREET GROUPINGS: REASONS AND MOTIVATIONS

2019 ◽  
Vol 29 (2) ◽  
pp. 195-199
Author(s):  
E.O. Chernova
Keyword(s):  
At Risk ◽  
Preventive Measures ◽  
Experimental Studies ◽  
Motivational Factors ◽  
Social Motives ◽  
Factors Affecting ◽  
Social Communities ◽  
Criminal Groups

The article gives an analysis of the results of authorial experimental studies. Motivational factors affecting adolescents' participation in criminal groups are considered, they are: dominant groups of motives, the predominance of aspiration to success or avoidance of failures. Thus, the author explores the subjective potential of the personality of adolescent groupers. According to the results of the research, the author concludes that the specificity of the motivation of such adolescents consists in the predominance of material motives, social motives (involvement in social communities, groupings) and motives of recognition and respect. The author notes that the motivation for avoiding failures is more characteristic of such adolescents than the motivation for the pursuit of success. It is concluded that the data obtained can serve as a basis for developing preventive measures when working with adolescents at risk.

The methodology of experimental research of the feed components extrusion process in order to improve its energy performance

2020 ◽  
pp. 147-152
Author(s):  
E. M. Ratnikov ◽  
D. O. Milko
Keyword(s):  
Experimental Studies ◽  
Energy Performance ◽  
Extrusion Process ◽  
Mathematical Methods ◽  
Screw Extruder ◽  
Mathematical Planning ◽  
Factors Affecting ◽  
Extrusion Processing ◽  
Definition Of

Annotation Purpose. Development of a program and methods for conducting experimental studies of the extrusion process with the definition of parameters and modes of operation of the extruder to improve its energy performance. Methods. Methods of mathematical statistics, synthesis, analysis, description and modeling were used. Results. The application of mathematical methods, in particular mathematical planning, reduces the number of experiments several times, and allows to evaluate the role of influencing factors, obtain a mathematical model of the process and determine the optimal conditions for its parameters and modes, etc. Conclusions. The methodology for experimental studies of a screw extruder is presented with the necessary equipment and methodology for processing the obtained experimental data. A mathematical method of planning, which reduces the number of experiments several times, allows us to evaluate the role of factors affecting productivity and energy intensity is presented. Keywords: extruder, auger, nutrients, research methodology, extrusion, processing, feed.

Quality by Design: Concept to Applications

2019 ◽  
Vol 16 (3) ◽  
pp. 240-250 ◽  
Author(s):  
Suryakanta Swain ◽  
Rabinarayan Parhi ◽  
Bikash Ranjan Jena ◽  
Sitty Manohar Babu
Keyword(s):  
Quality By Design ◽  
Pharmaceutical Products ◽  
Assessment Tools ◽  
Basic Knowledge ◽  
Target Product ◽  
Target Product Profile ◽  
Critical Material ◽  
Novel Approach ◽  
Product Profile ◽  
Performance Report

Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.

scholarly journals Blend Segregation in Tablets Manufacturing and Its Effect on Drug Content Uniformity—A Review

Pharmaceutics ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 1909
Author(s):  
Emilia Jakubowska ◽  
Natalia Ciepluch
Keyword(s):  
Active Pharmaceutical Ingredient ◽  
Content Uniformity ◽  
Continuous Manufacturing ◽  
Compression Process ◽  
Factors Affecting ◽  
Die Filling ◽  
Drug Potency ◽  
Tablet Press ◽  
Tablet Manufacturing ◽  
Processing Factors

Content uniformity (CU) of the active pharmaceutical ingredient is a critical quality attribute of tablets as a dosage form, ensuring reproducible drug potency. Failure to meet the accepted uniformity in the final product may be caused either by suboptimal mixing and insufficient initial blend homogeneity, or may result from further particle segregation during storage, transfer or the compression process itself. This review presents the most relevant powder segregation mechanisms in tablet manufacturing and summarizes the currently available, up-to-date research on segregation and uniformity loss at the various stages of production process—the blend transfer from the bulk container to the tablet press, filling and discharge from the feeding hopper, as well as die filling. Formulation and processing factors affecting the occurrence of segregation and tablets’ CU are reviewed and recommendations for minimizing the risk of content uniformity failure in tablets are considered herein, including the perspective of continuous manufacturing.

scholarly journals Study of the swelling pressure of coals and coal charges in the coking process

2021 ◽  
Vol 303 ◽  
pp. 01053
Author(s):  
Tatiana Cherkasova ◽  
Nikita Krasulin ◽  
Aleksandr Nevedrov ◽  
Andrey Papin ◽  
Sergey Subbotin
Keyword(s):  
Quality Indicators ◽  
Swelling Pressure ◽  
Coke Production ◽  
Coke Furnace ◽  
Coal Quality ◽  
Plastic Properties ◽  
Plant Laboratory ◽  
Factors Affecting ◽  
Central Plant Laboratory ◽  
The Relationship

The maintenance of furnaces is one of the most important problems for by-product coke production. Swelling pressure is one of the least studied factors affecting the lining of coke furnace walls. The results of studies of the swelling pressure of PJSC “Koks” feedstock coal are presented in this paper. Research has been carried out to identify the dependence of the swelling pressure on the coal quality indicators, estimated during the incoming control of the central plant laboratory of PJSC “Koks”. The plastic properties of PJSC “Koks” feedstock coals were studied using Gieseler plastometer. The relationship between the swelling pressure and the maximum coal fluidity is revealed.

scholarly journals Transport of engineered nanoparticles in soils and aquifers

2019 ◽  
Vol 27 (1) ◽  
pp. 43-70 ◽  
Author(s):  
Mahmood Fazeli Sangani ◽  
Gary Owens ◽  
Amir Fotovat
Keyword(s):  
Experimental Studies ◽  
Engineered Nanoparticles ◽  
Background Solution ◽  
Contributing Factors ◽  
Factors Affecting ◽  
Soil Systems ◽  
Aquifer Systems ◽  
Different Types ◽  
Transport Behaviour ◽  
The Media

Transport and deposition behaviour of engineered nanoparticles (ENPs) in natural aquifers and soil systems is a key determinant of the fate of these materials in environmental systems. A growing number of experimental studies are being conducted worldwide to address transport and deposition of ENPs in porous media (PM). Here we comprehensively review the main mechanisms and factors affecting the mobility of the environmentally important ENPs in natural PM. A variety of different processes including those that promote mobility and result in elution from the PM and those that hinder their mobility and promote ENP retention can influence ENP’s mobility through soil and aquifer media. The most important contributing factors regarding ENP transport in PM include: the physicochemical properties of the ENP, the media, the hydrodynamics of the system, and the background solution characteristics. Results from several studies conducted on the most common and environmentally important ENPs have shown that under natural environmental conditions, different types of ENPs show different transport behaviour in soil and aquifer systems. Additionally, the importance of media matrix and mobile solution factors in governing mobility of ENPs varies from one type of ENP to another.

scholarly journals A review of multiphase flow and deposition effects in film-cooled gas turbines

2018 ◽  
Vol 22 (5) ◽  
pp. 1905-1921 ◽  
Author(s):  
Jin Wang ◽  
Milan Vujanovic ◽  
Bengt Sunden
Keyword(s):  
Film Cooling ◽  
Gas Turbines ◽  
Particle Deposition ◽  
Experimental Studies ◽  
Turbulence Models ◽  
Phase Flow ◽  
Two Phase ◽  
Film Cooling Effectiveness ◽  
Factors Affecting ◽  
Multi Phase Flow

This paper presents a review of particle deposition research in film-cooled gas turbines based on the recent open literature. Factors affecting deposition capture efficiency and film cooling effectiveness are analyzed. Experimental studies are summarized into two discussions in actual and virtual deposition environments. For investigation in virtual deposition environments, available and reasonable results are obtained by comparison of the Stokes numbers. Recent advances in particle deposition modeling for computational fluid dynamics are also reviewed. Various turbulence models for numerical simulations are investigated, and solutions for treatment of the particle sticking probability are described. In addition, analysis of injecting mist into the coolant flow is conducted to investigate gas-liquid two-phase flow in gas turbines. The conclusion remains that considerable re-search is yet necessary to fully understand the roles of both deposition and multi-phase flow in gas turbines.

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