Оценка оптимальных условий сушки активной фармацевтической субстанции в псевдоожиженном слое при трансфере технологии дженерика

Цель работы: проведение валидации технологического процесса при производстве лекарственного препарата Эналаприл 10 мг. В процессе работы были изучены факторы, влияющие на проведение технологического процесса получения лекарственных препаратов методом влажного гранулирования в псевдоожиженном слое. Построена математическая модель планирования эксперимента на стадии получения массы для таблетирования, произведена оценка значимости коэффициентов уравнения. Подобраны оптимальные условия производства Эналаприл 10 мг, что было подтверждено валидацией процесса. В результате валидационных испытаний подтверждено, что процесс производства лекарственного препарата Эналаприл 10 мг воспроизводим и позволяет изготавливать продукт, соответствующий по качеству требованиям нормативной документации.The purpose of the work is to validate the process in the production of the drug Enalapril 10 mg. In the course of work, factors affecting the process of preparing drugs by wet granulation in a fluidized bed were studied. A mathematical model for planning an experiment at the stage of obtaining a mass for tableting was built; the significance of the coefficients of the equation was estimated. Optimal conditions for the production of Enalapril 10 mg were selected, which was confirmed by process validation. As a result of validation tests, it was confirmed that the production process of the drug Enalapril 10 mg is reproducible and allows the manufacturing of a product that meets the requirements of regulatory documents

The development and characteristics of a hand-held high power diode laser-based industrial tile grout removal and single-stage sealing system

As the field of laser materials processing becomes ever more diverse, the high power diode laser (HPDL) is now being regarded by many as the most applicable tool. The commercialisation of an industrial epoxy grout removal and single-stage ceramic tile grout sealing process is examined through the development of a hand-held HPDL device in this work. Further, an appraisal of the potential hazards associated with the use of the HPDL in an industrial environment and the solutions implemented to ensure that the system complies with the relevant safety standards are given. The paper describes the characteristics and feasibility of the industrial epoxy grout removal process. A minimum power density of approximately 3 kW/cm2 was found to exist, whilst the minimum interaction time, below which there was no removal of epoxy tile grout, was found to be approximately 0.5 s. The maximum theoretical removal rate that may be achievable was calculated as being 65.98 mm2/s for a circular 2 mm diameter beam with a power density of 3 kW/cm2 and a traverse speed of 42 mm/s. In addition, the characteristics of the single-stage ceramic tile grout sealing are outlined. The single-stage ceramic tile grout sealing process yielded crack and porosity free seals which were produced in normal atmospheric conditions. Tiles were successfully sealed with power densities as low as 550 W/cm2 and at rates of up to 420 mm/min. In terms of mechanical, physical and chemical characteristics, the single-stage ceramic tile grout was found to be far superior to the conventional epoxy tile grout and, in many instances, matched and occasionally surpassed that of the ceramic tiles themselves

Removal and transfer of material in laser-assisted physical vapour deposition of ceramics

The removal and transfer of ceramic target materials in laserassisted physical vapour deposition are investigated as a function of laser parameters and processing variables. Removal was measured by a microbalance and characteristics of distribution, transfer by emission spectroscopy and high-speed photography. The composition, the ionization state of the particles and the electron temperature of the vapour/plasma govern the structures of the thin filsm deposited, which are discussed in view of applications

St. John's Daily Star, 1919-05-21

The St. John's Daily Star was published daily except Sunday between 17 April 1915 - 23 July 1921

Properties and applications of single-component (Al2O3, ZrO2, BN) and multi-component films (ZrO2, Ti) fabricated by pulsed laser deposition

Single-component films of cerammic materials (Al2O3, ZrO2, BN) as well as multi-component films and controllably inhomogeneous films (ZrO2, Ti) were investigated. The deposition was performed using different laser parameters (wavelength, fluence, mode of operation) and processing variables (processing gas pressure and composition, r.f. bias, target-substrate distance). The investigations included microbalance measurements of the weight loss of the target as a measure of mass removal as well as high-speed photography and emission spectroscopy as a measure of geometry, dynamics and excitation of the vapour-plasma state generated. The morphology, structure and composition of the film were investigated by scanning electron microscopy, X-ray photoelectron spectroscopy, Auger electron spectroscopy and scanning Auger microscopy showing a broad variety of different film properties useful for applications. Al2O3 films deposited with pulsed CO2 and excimer laser radiation were dense and glassy. ZrO2 films deposited with CO2 laser radiation had a columnar structure. BN films deposited with excimer laser radiation consisted of hexagonal BN crystallites embedded in an amorphous matrix. Thin films produced with excimer laser radiation had a nearly flat and defect-free surface allowing the construction of multilayer systems and graded or homogeneous doped layers