DEVELOPMENT AND EVALUATION OF LYOPHILIZED POWDER TO PREPARE SOLUTION FOR INJECTIONS BASED ON DOXYCYCLINE

The range of doxycycline drugs on the pharmaceutical market of the Ukraine is very limited and is represented by solid forms (capsules and tablets) while a rapid effect and maximum bioavailability of the drug can be provided by parenteral administration. The object of the study is the drug doxycycline hyclate in the form of lyophilisate to prepare solution for injections. During the development of the drug it was taken into account that aqueous doxycycline solution is pH dependent and tends to shift the solution pH during long-term storage. Therefore, excipients such as stabilizer and antioxidant providing buffering properties and stability of the solution were introduced into the composition. According to the research results an optimal composition of lyophilized powder was selected, the production technology with the stage of solution treatment with activated carbon was developed which allowed to obtain lyophilized powder with a well-formed porous mass without splits, cracks and fissures, resistant to shaking, and the prepared solution for parenteral administration is stable by the «Degree of coloration» quality indicator during accelerated storage regimen. It was found that doxycycline hyclate in the form of a lyophilisate shows a wide range of antibacterial activity. Comparative studies in vitro for two drugs, in the form of lyophilisate with doxycycline hyclate for injections and hard gelatin capsules with 100 mg of doxycycline hyclate, confirm equivalence of their bacteriostatic action against bacteria causing infectious diseases in humans.

ANTI-INFLAMMATORY ACTIVITY OF THE SPRAY BASED ON IBUPROFEN AND LIQUID WORMWOOD EXTRACT

The article presents the results of determining anti-inflammatory activity of the spray based on ibuprofen and liquid wormwood extract. Anti-inflammatory activity was studied on the model of local acute carrageenan inflammation. As a result of the studies it was found that the increase in paw weight averaged 49,66% in the control group of rats, in the group of rats receiving the comparison drug «Ibuleve» - 11,26%. For the group of rats receiving combined composition and the same composition without ibuprofen, the average increase in paw weight was 7,11% and 15,07%, respectively. The index of inflammatory inhibition when using combined composition was 85,68%, the composition with liquid extract of wormwood without ibuprofen was 69,65%, the liquid extract of wormwood 1:1 was 53,00%. The index of edema suppression proves that combined composition of the spray containing ibuprofen and liquid extract of wormwood has the most pronounced anti-inflammatory effect, for which the percentage of edema suppression exceeds the value for the comparison drug on the average by 8,36%.

PROBLEMS OF MAKING QUALITY ASSURANCE DOCUMENTATION

The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.

PROSPECTS FOR CREATING RADON CONTAINING AGENTS IN RADIONUCLIDE THERAPY

One of the methods for treating oncological diseases is application of short-lived radionuclides. Existing risks of intoxication and radioactive contamination can be eliminated by introduction of a short-lived radon isotope into a hard strong fullerene coat. To increase the effectiveness of these drugs it is promising to introduce structural fragments of amino acids, peptides, steroid hormones, nucleic bases or heterocyclic compounds being able to accumulate exactly in tumoral but not in healthy tissues of the body. The article presents data on quantum-chemical simulation of electronic structure and thermodynamic stability of fullerenol radon-containing agents of radionuclide therapy on the example of a model cortisonefullerenol bioconjugate.

TO THE QUESTION ABOUT COMMUNICATIVE TOLERANCE OF THE PHARMACEUTICAL STUDENTS OF VSMU

The aim of the research is to study communicative tolerance of students of the Pharmaceutical Faculty of VSMU and analyze its dynamical characteristics. When comparing the degree of communicative tolerance for the 1^st, 2^nd and 5^th year students respectively, there is a tendency towards a decrease in high and low degree of communicative tolerance and an increase in its average degree. It suggests about positive influence of the educational process on the communicative competence formation of a future pharmacist. Students with a high level of scale indicators (low degree of communicative tolerance) should be within the view of teachers of the Faculty of Pedagogics and Psychology with the course of Retraining and Advanced Training Faculty, employees of the social and pedagogical and psychological services, curators of academic groups and tutors.

RULES FOR DETERMINING THE ORDER OF DISPENSING DRUGS IN THE EURASIAN ECONOMIC UNION: APPLICATION, FEATURES

The article is devoted to the rules of determining the order for dispensing drugs in the Eurasian Economic Union (hereinafter - the Union). It is shown that when registering drugs and making changes to the registration dossier in the Member States of the Union prescription drugs with conventional, special (containing narcotic or psychotropic substances in the composition), limited (used exclusively at a hospital or causing very serious adverse reactions) prescription may be sorted out. Active ingredients in prescription drugs are also classified depending on the possibility of re-sale using the same recipe. Over-the-counter drugs are those meeting relevant criteria based on their safety profile. In addition, over-the-counter drugs may be those containing prescription active ingredients but with the lower dosage, the number of doses in the package and another route of administration.

DETERMINATION OF SOIL TROPHICITY BY ELECTROPHYSICAL METHOD. MESSAGE 1. DEVICE AND LABORATORY TECHNIQUE

The purpose of this work was to develop a device and technique for determining the soil trophiсity using the electrophysical method based on the measurement of the soil specific resistivity (SR). In the proposed device the F. Wenner installation is used as a sensor. The device has a modular design and includes a voltage boosting module, a PWM generator of rectangular pulses, a rectangular signal inverter and an H-bridge that switches the polarity of the power supply in order to prevent polarization of the electrodes. The metrological characteristics of the specific resistivity measurement as well as the influence of the electrodes immersion depth in the substrate studied are determined. Its significant influence and nonlinear character which was well approximated by the power function were established. The simplest equations for bringing the measured values of the RS to a certain depth of the electrodes in the object studied are proposed.

ANTI-ALLERGIC ACTIVITY OF VIOLA HERB TEA

Widespread occurrence of allergic diseases requires the search for new medicines to solve this problem including their search through natural sources. The aim is to study anti-allergic activity of Viola herb tea in comparison with Bidens medicinal plant raw material. It was found that Viola herb tea containing polysaccharides and phenolic compounds has a pronounced dose-dependent and anti-anaphylactoid effect in vivo comparable to Bidens herb tea; a semi-effective dose of Viola herb tea made 342 mg/kg. The level of mast cell degranulation in the group studied in the presence of Viola herb tea was in the range of 14,5-21,0% and at all doses was significantly lower (p < 0,05) than the level of mast cell degranulation in animals of the studied group in the presence of an allergen. The percentage of mast cell protection against degranulation in vitro of Viola herb tea is 31,2-65,7%. A semi-effective dose of Viola herb tea on the model of mast cell membranes stabilization is 433 ng/ml and is 1,6 times inferior to Bidens herb tea.

ASSORTMENT ANALYSIS OF DRUGS FOR THE TREATMENT OF MILD AND MODERATE ULCERATIVE COLITIS

The article is devoted to the assortment analysis of 5-aminosalicylic acid drugs used for the treatment of mild and moderate ulcerative colitis. A brief description of dosage forms for oral and rectal administration used for the treatment of this disease is given. It is shown that therapeutic efficacy of the drug is associated with the concentration of the active substance in the large intestine. Therefore, in order to increase its effectiveness it is important to use such dosage forms that would help to prevent and reduce mesalazine absorption in the proximal small intestine and contribute to maximum release in the large intestine. It is shown that the rectal suspension of mesalazine, which is a first-line drug and is included in the list of essential medicines, is not produced in the Republic of Belarus. Special attention is paid to the possibility of expanding the range of mesalazine drugs if there is a possibility of extemporal suspension production from tablets presented in the assortment including a domestic manufacturer.

NOMENCLATURE ANALYSIS OF MEDICINES PREPARED BY PHARMACIES OF RUE «BELPHARMATSIYA»

The article is devoted to the nomenclature analysis of medicines prepared at 21 pharmacies of the 1^st category of RUE «BELPHARMATSIYA», the largest state pharmacy network in Minsk. Medicines preparation at pharmacies is carried out according to the doctors’ prescriptions and the requirements (applications) of healthcare organizations as well as in the form of intra-pharmacy stocking and packing. The main tasks of pharmacy preparation are: providing the population and healthcare organizations with dosage forms not manufactured by industry, preparation of dosage forms mainly used in pediatric and geriatric practice, individual pharmacotherapy provision. Pharmacists make from 38 to 174 dosage forms in one day. The nomenclature of the medicines prepared numbers 392most common prescriptions of which 47,2% prescriptions are unique: they were prepared by one pharmacy only. The most prevalent (42,8%) is preparation of complex in composition dosage forms which contain at least 4 ingredients. Therefore, there is an urgent question about the stability of dosage forms and shelf life detection (currently, the legislation hasn’t established shelf life of medicines prepared at pharmacy). The assortment of active ingredients and excipients has been analyzed. There are cases of medicines preparation from industrial medicines. The need for almost 100 names of active ingredients has been established. Nomenclature analysis of the prescriptions has confirmed the importance of medicines preparation development at a pharmacy to provide the population with medicines.