Enhancement of Manufacturing Technology for Finished Dosage Form of Bivalent Chemical Tableted Cholera Vaccine

Objective of the study is to experimentally substantiate the possibility to improve manufacturing efficiency by means of mass reduction of a vaccine tablet from 300 to 100 mg. Materials and methods. Inaba O-antigen lyophilizate serves as the specific immunogenic component of the vaccine. Results and conclusions. It is identified that it is expedient to produce tablets of 6 mm in diameter. Justified is the quantitative content of additive substances (lactose monohydrate, micro-crystal cellulose, and polyvinylpyrolidone). Moreover, the studies have specified target values for technological parameters of such processes as fluid bed granulation of the formula with overfeed of the binder, tablet compression and enteric-coating (Acryl-eze) application to finished dosage form. Using Inaba O-antigen lyophilizate manufactured has been model experimental series of the vaccine. Investigated have been its characteristics. Verified vaccine quality indicators testify to the compliance of the product with the requirements of manufacturer’s pharmacopoeial monograph. The studies exercised showed the possibility in principle to enhance manufacturing efficacy through the decrement of additives amounts, and thus the mass of a vaccine tablet from 300 up to 100 mg

DEVELOPMENT OF PHARMACEUTICAL DOSAGE FORM OF ANTI-CHOLERA IMMUNE-ENTEROSORBENT

Objective of the study is to experimentally substantiate the possibility of production of anti-cholera immune-enterosorbent in the pharmaceutical form of a pill.Materials and methods: experimental antitoxic immune-enterosorbent against cholera, stabilized using cool dehumidification. Residual moisture of enterosorbent lyophilizate was determined by means of Sartorius MA 150 moisture meter. Screen assay of the powders and granulates was performed applying the sieving of bulk material samples through screen set with sieve openings of various sizes. Specification of tap density was carried out with the help of SVM-10 unit. Granulation of specific enterosorbent was done using GPCG 2 LabSystem. The pills were manufactured in tablet press, MiniTabT. The hardness of the pallets was carried out by means of TBH 125 TD tester. The test for friability of the pills was performed in GTA 120.Results and conclusions. Utilization of cellulose microcrystalline and polyvinyl pyrolidone as pharmaceutical aids for granulation of lactose monohydrate is experimentally substantiated. It is established that the obtained granulate with passable values of technological parameters can serve as the basis for pharmaceutical dosage form of specific enterosorbent. Identified has been optimum mass of anti-cholera enterosorbent tablet cores. Demonstrated has been the possibility of Acryl-eze enteric coating application as protective shell of the pills. Studied has been specific activity of the pelleted enterosorbent in vitro, verified is its resistance capacity under conditions modeling gastrointestinal tract. In consequence of the performed trials and tests, technology for the production of antitoxic enterosorbent against cholera – enteric-coated tablet – has been developed. Long-term trials: the storage of the constructed preparation at 4–8°C within 24 months period (the observation time) – have revealed retention of enterosorbent activity, which testifies to its stability and defined the shelf life of specific tableted anti-cholera immune-enterosorbent

Методика випробувань грунтів універсальним динамічним зондом лдате

Problem statement. Nowadays the survey organizations need in facilities of light type not being produced mass.But they are necessary for the accelerated testing of soil with the possibility of use in  cramped conditions. Described below probe and test procedures is one of the possible solutions to this problem.Purpose. To acquaint with a description of the constructional features and testing methods of soil dynamic universal probe, developed in the laboratory of research of nuclear and thermal power plants (LRNTP) of Pridneprovsk scientific and educational institution of innovative technologies in construction.Conclusion. The proposed probe intended to determine the mechanical properties of soils and allows to provide the express assessment of the soil properties of natural foundations to explore the changes of the properties of soil foundation under the operative objects in the process of their operation. Universal feature of the probe is the possibility to use disposable standard cones and of the composite construction of hammer (if it is necessary to reduce the weight of the hammer). As well as the possibility of carrying out tests on foreign standards, in particular on standard for the SPT (Standard Probe Test). Results of probing are drawn up as a standard continuous step schedule of change of depth value of conditional dynamic resistance of soils Pq, followed by averaging schedule and calculating of weighted index of probing for each layer land constructions. This probe and the following technique, fill a niche of the lack of manual small facilities and can contribute to the expansion of technical capabilities of survey organizations.Постановка проблемы. В наши дни изыскательские организации испытывают потребность в установках легкого типа, которые не производятся серийно. Но они являются необходимыми для ускоренного испытания грунтов с возможностью применения в стесненных условиях. Описанный ниже зонд и методика проведения испытаний – один из возможных вариантов решения поставленной задачи.Цель роботы. Ознакомить с описанием конструктивных особенностей и методики испытаний грунтов универсального динамического зонда, разработанного в Лаборатории исследования атомных и тепловых электростанций (ЛИАТЭ) Приднепровского научно-образовательного института инновационных технологий в строительстве.Вывод. Предлагаемый зонд предназначен для определения механических свойств грунтов и позволяет обеспечить экспресс-оценку свойств грунтов естественного основания, исследовать изменения свойств грунтов основания под действующими объектами в процессе их эксплуатации. Универсальной особенностью зонда является возможность применения одноразовых (теряющихся) стандартных конусов и составной конструкции молота (при необходимости уменьшения веса молота), а также возможность проведения испытаний по зарубежным стандартам, в частности, по стандарту для SPT (Standart Penetration Test). Результаты зондирования оформляют в виде стандартного непрерывного ступенчатого графика изменения по глубине  значения  условного динамического сопротивления грунтов Рq с последующим осреднением графика и вычислением средневзвешенных показателей зондирования для каждого слоя земляного сооружения.Данный зонд и указанная ниже методика заполняют нишу в недостатке ручных малогабаритных установок и могут способствовать расширению технических возможностей изыскательских организаций.Постановка проблеми. Сьогодні вишукувальні організації відчувають потребу в установках легкого типу, які не виробляються серійно. Але вони необхідні для прискореного випробування ґрунтів із можливістю застосування в обмежених умовах. Описаний нижче зонд і методика проведення випробувань - один із можливих варіантів вирішення проблеми.Мета статті - ознайомити з описом конструктивних особливостей і методики випробувань ґрунтів універсального динамічного зонда, розробленого в Лабораторії дослідження атомних і теплових електростанцій (ЛДАТЕ) Придніпровського науково-освітнього інституту інноваційних технологій у будівництві.Висновок. Пропонований зонд призначений для визначення механічних властивостей ґрунтів і дозволяє забезпечити експрес-оцінку властивостей ґрунтів природної основи, досліджувати зміни властивостей ґрунтів основи під діючими об'єктами в процесі їх експлуатації. Універсальною особливістю зонда є можливість застосування одноразових (які втрачаються) стандартних конусів і складової конструкції молота (за необхідності зменшення ваги молота), а також можливість проведення випробувань за зарубіжними стандартами, зокрема, за стандартом для SPT (Standart Penetration Test). Результати зондування оформляють у вигляді стандартного безперервного ступеневого графіка зміни за глибиною значення умовного динамічного опору ґрунтів Рqіз подальшим усередненням графіка і обчисленням середньозважених показників зондування для кожного шару земляної споруди. Даний зонд, певною мірою, заповнює нішу в нестачі ручних малогабаритних установок і сприяє розширенню технічних можливостей вишукувальних організацій

Biological kinetics of candida albicans clinical strains filmforming in patients with bronchopulmonary complications of traumatic spinal cord disease

The intensity of 10 C. albicans clinical strains filmforming in patients with bronchopulmonary complications of early traumatic spinal cord disease was studied in statistic condition of flatbed culture on the 1 st, 2 nd, 3 rd, 4 th and 5 th days. It was specified that life cycle of C. albicans has phase character and is characterized by quantitative changes in the intensity of its filmforming

INFLUENCE OF THE METHOD OF LAPAROSCOPIC SUTURING OF PERFORATED PYLORODUODENAL ULCERS ON MOTOR-EVACUATION FUNCTION OF THE STOMACH AND DUODENUM IN EARLY POSTOPERATIVE PERIOD

The authors researched the influence of different methods of laparoscopic suturing of perforated pyloduodenal ulcers on motor-evacuation function of the stomach and duodenum in 133 patients with peptic ulcer. There were used different methods such as single-row endo-stitch, two-row endo-stitch, omentopexy. The motor-evacuation function of the stomach and duodenum was studied by roentgenocinescopy in the early postoperative period. It was stated, that frequency and intensity of violation of motor-evacuation functions were reliably low in case of imposing the single-row endo-stitch than using the two-row endo-stitch and the omentopexy in the early postoperative period

Ways to Reduce the Level of Contamination at the Stages of Tableted Chemical Cholera Vaccine Production

Objective of the study was an assessment of the degree of contamination of cholera chemical vaccine at the stages of preparation and determination of the ways to reduce it.Materials and methods. Liquid and lyophilized components of the cholera chemical vaccine used in the study: cholerogen-anatoxin and O-antigens of Vibrio cholerae 569B and V. cholerae M-41 strains, as well as auxiliary substances (sucrose, talc, calcium stearate, starch). Granulation was carried out in a device that works on a fluidized bed principle, GPCG 2 (GLATT, Germany). Subsequent tabletizing of the mixture was performed using MiniTabT compression machine (LUXNER, Germany). Studies were conducted on the evaluation of “microbiological purity” at the stages of manufacturing of the cholera chemical vaccine, tablets coated with an enteric coating. Positive or negative growth of microorganisms on Petri dishes with nutrient media was determined on visual inspection.Results and conclusions. The dynamics of changes in microbial contamination at certain technological stages of vaccine production has been revealed. It is shown that the solutions of antigens in the process of separation are subject to microbial contamination which is associated with the use of ammonium sulfate during precipitation and non-sterile water at the stage of dialysis. Sterility of semi-finished products has been achieved through twophase filtration of choleragen-anatoxin and sterilization of O-antigens of V. cholerae 569B and V. cholerae M-41 strains with flowing steam at (100±1) °C for 30 minutes. In order to decrease microbial contamination at the stage of granulation additional fine filters were installed in the air-supply system. Further on comparative assessment of microbial purity of vaccine batches obtained using both, direct compression and preliminary granulation, was carried out. It has been experimentally demonstrated that granulation of the components of a tablet mixture of cholera vaccine leads to a decrease in the level of bacterial contamination and improves the microbiological purity of the finished dosage form

Disinfection of Biological Aerosols in the Removed Gas During the Fermentation Stage of the Biotechnological Process

The aim of this review is to consider the literature data on methods and engineering solutions for decontamination of gases vented from equipment, containing microorganisms, during the cultivation process. Methodological approaches and engineering solutions for the removal or inactivation of microorganisms contained in a biological aerosol are addressed. A number of examples demonstrate the advantages and disadvantages of biological aerosol decontamination systems used. Presented is the information about modern, non-moisture-absorbing membrane filters, announced by manufacturers as elements that allow for sterilization of air supplied for oxygen saturation of the culture medium in bioreactors and neutralization of the gas removed from them. Discussed in detail are designed by specialists of the Institute “Microbe” system for purification of exhaust gases from the bioreactor, where hydrophobic filters based on sintered mass of nickel powders are the main element. Requirements for the construction of systems for the neutralization of microorganisms in gases drawn off from equipment in which biotechnological processes take place are formulated