Production Of Pharmaceutical Substances Research Articles

State support of Investment Projects Within the Framework of an Agreement on the Protection and Promotion of Capital Investments: A Methodological Rationale

The subject of research is economic interactions related to the implementation of an investment project within the framework of an agreement on the protection and promotion of investments (hereinafter referred to as the APCI).Purpose: methodological substantiation of the expediency of providing state support measures to ensure the minimum profitability of an investment project implemented within the framework of the APCI.Objectives: to propose an indicator that reflects the minimum profitability of an investment project, the mechanism for its usage to determine state support measures, additional state support measures in cases where they are not sufficiently established in the legislation.Methods: analysis of approaches to determining the discount rate; statistical (observation, grouping, method of indicators) for calculating industry-specific ROIC values; content analysis to select state support measures.Results: it is proposed to use the ROIC indicator as the minimum profitability of a commercial investment project. The indicator was calculated according to the data of all organizations that are not subjects of medium and small enterprises operating in the period 2012–2021. The sample included 133 organizations that make up eight subclasses of Russian classifier of types of economic activity (pulp and paper production; production of fertilizers and nitrogen compounds; production of pesticides, etc.; production of paints, varnishes, etc.; production of pharmaceutical substances; production of medicines; activities in the field of telecommunications; development of computer software). Based on the data from 1011 observations, the median value of ROIC for each subclass was calculated, the reliability of which is confirmed by the approved minimum rates of return on invested capital for calculating the tariffs of regulated organizations. A mechanism is proposed for using ROIC to determine state support measures within the framework of the APCI, including: determining the median value of ROIC for foreign economic activity, calculating ROIC for an investment project, and determining state support measures by their ratio. As additional measures of state support within the framework of the APCI, it is proposed to establish tax preferences (lower tax rates, tax benefits, tax deductions), as well as accelerated depreciation of fixed assets. The proposed developments create a methodological basis for substantiating the provision of various state support measures within the framework of the APCI.

On mechanisms of mixing by forced and natural convection in microfluidic devices

Continuous-flow microfluidic devices are applied in the study of microorganisms, in genetic research, production of pharmaceutical substances, lab-on-a-chip technology, biomedicine etc. Some applications require continuous mixing of the solutions that flow through the devices. However, straight-line mechanical mixing methods cannot be used due to the small size of the channels. In this paper, we discuss from a theoretical and experimental point of view the prospects of using various mechanisms of natural or forced convection for efficient mixing of solutions entering a microfluidic chip. Different designs of micromixers operating on gravity-dependent instabilities of the Rayleigh-Taylor type, double diffusion convection, and surface-dependent Marangoni instability are considered. Micromixers, in which the fluid flow is controlled by an electro-osmotic mechanism and directional deformations of the channel walls, are considered as examples of forced convection. For each case, we will provide the assessment of the range of chip sizes in which this mixing mechanism works effectively. The examples of experimental implementation of different mixing principles are given.

Improving the Technology of Extraction, Preparation and Conservation of Musk Deer Extract for the Standardization and Production of Pharmaceutical Substances

The development of new methods for the conservation of biological raw materials, which can be used in the production of active pharmaceutical substances, is increasingly attracting research attention. This article presents the results of comparative studies into the effectiveness of biological conservation using cryopreservation, electron beam treatment and the lactoperoxidase system. Electron beam technologies demonstrated a pronounced antimicrobial effect in the treatment of musk deer extract and other biologically active substances. A recommendation was formulated to treat musk extract with electron-beam radiation at an absorbed dose of 6 kGy (9.5 MeV) following cryopreservation at –25°C over the period of 1 year. The data obtained using the method of accelerated testing allows an extended shelf life of up to 48 months to be predicted.For the first time, the main indicators of the quality and safety of musk deer extract as a potential raw material for the production of active pharmaceutical substances and medicinal animal raw materials were determined. A standard for the quality of musk deer extract as a raw material, as well as an experimental-industrial regulation for its preparation and preservation, were developed.

MODERN ASPECTS OF HOMEOPATHIC MEDICINES STANDARDISATION

The article describes the status of homeopathic medicines standardisation in the leading world pharmacopoeias. It reviews main requirements for raw materials of plant, animal, and mineral origin, which are used in the production of homeopathic medicines. It also considers requirements for homeopathic pharmaceutical substances, including technologies of obtaining homeopathic mother tinctures, homeopathic dilutions, triturations, etc., mono- and multi-component homeopathic medicines, as well as quality control of homeopathic substances and homeopathic medicines. The article analyses the nomenclature of homeopathic raw materials and homeopathic substances used by the leading world pharmacopoeias. It dwells upon the results of work devoted to the development of requirements for the following homeopathic dosage forms: homeopathic granules, homeopathic eye drops, homeopathic ointments, homeopathic infusions and decoctions, homeopathic mother tinctures, homeopathic solutions for injection, homeopathic solutions and liquid dilutions, homeopathic syrups, homeopathic mixtures, homeopathic suppositories, homeopathic tablets, homeopathic triturations. The article illustrates significant potential of using vibrational spectroscopy and Raman spectroscopy for the detection of distinctive features of homeopathic medicines at ultra-high dilutions. The article presents methodology for structuring pharmacopoeial standards for raw materials used in the production of pharmaceutical substances, for pharmaceutical substances that are used in homeopathic medicines, and for dosage forms, including specific aspects of production and standardisation of homeopathic medicines, which was implemented during preparation of draft monographs for the State Pharmacopoeia of the Russian Federation.

Objektive Zellkultur-Qualitätskontrolle durch infrarotspektroskopische Untersuchungen

Cell culture has become one of the major tools in life science today. In addition to the study of cell functions for fundamental research, the use of cell lines for the production of pharmaceutical substances is of great importance. Evaluating the general health of a cell culture is usually based on different cell characteristics. Mid-infrared spectroscopy in combination with chemometric methods proves to be highly suited for this purpose in terms of reproducibility, objectivity, cost-effectiveness and speed.

The impact of hybrids between genetically modified crop plants and their related species: general considerations

AbstractFactors influencing the fate and impact of hybrids between crop plants and their related species operate from the early zygote, through to plant establishment in different habitats, to their ability to form self‐sustaining populations. Many of the classes of genes being introduced by modern methods of genetic modification are similar to those manipulated by conventional plant breeding. In assessing the impact of transgenes in hybrids between crops and related species, therefore, it is important to be informed about the consequences of hybridization between conventionally bred varieties and their relatives. Some transgenes will have novel effects (e.g. production of pharmaceutical substances or certain fatty acids) on plants, and are likely to need specific assessment studies to determine their impact on hybrids. This will be particularly important if there is the possibility of these transgenes becoming established in wild populations. Some recommendations for further research are outlined.