scholarly journals DEVELOPMENT OF A TECHNOLOGY FOR PRODUCING A STABLE INJECTABLE DOSAGE FORM OF A HYDROPHOBIC INDOLOCARBAZOLE DERIVATIVE

2021 ◽  
pp. 232-235
Author(s):  
MARIA DMITRIEVA ◽  
ALEXANDER KOLPAKSIDI ◽  
OLGA ORLOVA ◽  
ELENA IGNATYEVA ◽  
ANNA LANTSOVA ◽  
...  
Keyword(s):  
Aqueous Solution ◽  
Polyvinylidene Fluoride ◽  
Dosage Form ◽  
Active Pharmaceutical Ingredient ◽  
Average Weight ◽  
Nylon Membrane ◽  
National Medical ◽  
The Russian Federation ◽  
Freeze Dryer ◽  
Injectable Dosage

Objective: Development of a technology for the production of a stable injectable dosage form (IDF) of indolocarbazole derivative LHS-1269. Methods: LHS-1269 is an active pharmaceutical ingredient that was synthesized in the N. N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation. The IDF includes dimethyl sulfoxide (DMSO), 95% ethanol, Kollidon® 17PF and water for injection. Magnetic stirrer and overhead stirrer with a propeller stirring element were used to prepare the model solution of the IDF of LHS-1269. Sterilizing filtration of the solution was performed with 0.2−0.22 um polycarbonate, cellulose, polyvinylidene fluoride, polyethersulfone and nylon membrane filters. The aqueous solution of LHS-1269 was lyophilized in Edwards Minifast DO.2 freeze dryer. Assay of LHS-1269 was performed by spectrophotometry at 320±3 nm. Potentiometry was used to measure pH, a viscosimetry method was used to measure the viscosity of the solutions. The average weight was estimated by weighing a sample of 10 vials with the concentrate. Results: 0.5% aqueous solution of LHS-1269 was produced by mixing the solution of the active substance in DMSO and ethanol with an aqueous solution of polyvinylpyrrolidone gradually at the ratio of LHS-1269/DMSO/ethanol/Kollidon® of 1/11/32/40 by weight. The aqueous solution of the study substance cannot be lyophilized, so a sequence of technological operations was presented to produce an anhydrous concentrate “LHS-1269, concentrate for solution for injection and infusion 25 mg”. Conclusion: A technology was developed to produce a stable IDF of a hydrophobic indolocarbazole derivative LHS-1269, a high-potential antitumor drug.

Stability Indicating Photodiode Array Detector Based Estimation of Dapagliflozin Propanediol Monohydrate in API and Tablet Dosage Form by RP-UPLC

2021 ◽  
pp. 4635-4639
Author(s):  
Ashok B. Patel ◽  
Ekta H. Vaghasiya ◽  
Amit R. Dudhatra ◽  
Amitkumar J. Vyas ◽  
Ajay I. Patel ◽  
...  
Keyword(s):  
Dosage Form ◽  
Active Pharmaceutical Ingredient ◽  
Array Detector ◽  
Column Temperature ◽  
Stability Indicating ◽  
Photodiode Array Detector ◽  
Acceptable Method ◽  
Photodiode Array ◽  
Tablet Dosage

Stability indicating RP-UPLC photo diode array detector based method for determination of Dapagliflozin propanediol monohydrate (DPM) in active pharmaceutical ingredient (API) and in tablet dosage form (5mg dapagliflozin) has been developed and validated on Bridge Ethylene Hybride (BEH) C18 column (50mm × 2.1 mm, 1.7µm). Mobile phase composition was water: acetonitrile (60:40 v/v), flow rate 0.5ml/min and detection carried out at 223nm at column temperature 30ºC. Chromatographic separation achieved within 2 min with retention time 0.77 min. Linearity of the method was found over the concentration range of 25-75µg/ml (R2 = 0.9977). The degradation was carried out in five different stress conditions. The developed method was able to resolve peak of API from all generated peaks. Sufficient degradation was achieved in the range of 5.25 to 12.31%. The peak purity is acceptable, Method validation was performed as per ICH guideline Q2(R1).

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING REVERSE-PHASE HIGHPERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE SIMULTANEOUS QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS OF REGADENOSON FROM ITS PARENTERAL DOSAGE FORM

2018 ◽  
Vol 11 (8) ◽  
pp. 277
Author(s):  
Murlidhar V Zope ◽  
Rahul M Patel ◽  
Ashwinikumari Patel ◽  
Samir G Patel
Keyword(s):  
Liquid Chromatography ◽  
Degradation Product ◽  
Mobile Phase ◽  
Dosage Form ◽  
Degradation Products ◽  
Reverse Phase ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Liquid Chromatography Method ◽  
Injectable Dosage

Objective: The objective was to develop and validate the stability indicating reverse-phase high-performance liquid chromatography method for the quantification of potential degradation products of regadenoson (REGA) from its injectable dosage form.Methods: YMC-PAK ODS AQ, 150 mm × 4.6 mm, 3 μm composed with hydrophobic high carbon loading and a relatively hydrophilic surface chemically bonded to porous silica particles column was used with the temperature maintained at 40°C. Mobile phase A composed of 0.1% triethylamine buffer having pH 4.5 while mobile phase B is 100 % acetonitrile was used for gradient elution with 1.5 ml/min as a flow rate. The wavelength used for quantification was 245 nm and 20 μl as an injection volume. The suitability of the method has been checked and validated according to the International Council for Harmonization (ICH) guidelines for different parameters, namely, specificity, linearity, accuracy, precision, limit of quantification (LOQ), Limit of detection (LOQ), and robustness studies.Results: The resolution between REGA and its two-degradation product is >8.0 for all pairs of components. The high correlation coefficient (r2>0.990) values are for drug and all potential degradation products from LOQ to 150% of specification limits for impurities calculated based on the maximum daily dose of REGA. LOQ for the drug as well as each degradation product is <0.02% w/w. The % relative standard deviation (RSD) for precision and intermediate precision is in the range of 0.17–0.89, and % RSD for precision at LOQ is 0.86–2.35. The % RSD for robustness study is maximum 2.59.Conclusion: The developed method can quantify the specified and unknown degradation products from 0.1% in the injectable dosage form which indicates that method is sensitive. Method fulfills the ICH criteria for its different validation parameters and demonstrates that the developed analytical method is highly specific, precise, and robust and would have a great value when applied in quality control and stability studies for REGA injection.

Formulation and Evaluation of an Injectable Dosage Form

2019 ◽  
Vol 11 (1) ◽  
pp. 47
Author(s):  
Sneha Thomas ◽  
R. Selvakumar ◽  
S Mahendran
Keyword(s):  
Dosage Form ◽  
Injectable Dosage

scholarly journals Investigating Membrane Material and Morphology for Development of Lateral Flow Biosensor

2017 ◽  
Vol 15 (1) ◽  
Author(s):  
R. Shaimi ◽  
A. L. Ahmad ◽  
S. C. Low
Keyword(s):  
Drinking Water ◽  
Protein Binding ◽  
Polyvinylidene Fluoride ◽  
Lateral Flow ◽  
Cellulose Acetate Membrane ◽  
Binding Ability ◽  
Nylon Membrane ◽  
Sensing Applications ◽  
High Protein Binding ◽  
Experimental Findings

Development of membrane for bio–sensing applications, such as the detection of pathogens in drinking water for epidemics control has a huge global impact especially for public health. Membrane that applied in the bio–sensing devices should fulfill requirements such as high binding ability, fast lateral wicking time and low background staining. This paper explores the selection of membranes, including Nitrocellulose membrane (NC), Cellulose Acetate membrane (CA), Polyvinylidene Fluoride membrane (PVDF) and Nylon membrane for the detection of pathogens in water in the most efficient and rapid way. Membrane modification using glutaraldehyde enable the achieved of higher sensitivity of protein binding. Experimental findings (FTIR, porosity, membrane’s binding ability and lateral wicking time) verified the most suitable membrane for bio-sensing application. Among the tested membranes, NC appeared as the most suitable lateral flow membrane as its performances of high protein binding ability and fast lateral wicking time. Throughout this study, we showed the correlation of membrane’s material and morphology to its performances for pathogens detection in drinking water.

scholarly journals Certification of the service of pediatric hematology-oncology in the subjects of the Russian Federation on the basis of infographic mapping

2019 ◽  
Vol 6 (1) ◽  
pp. 20-27 ◽  
Author(s):  
S. A. Kogan ◽  
Ya. A. Erdomaeva ◽  
T. G. Serik ◽  
D. V. Birlyukova ◽  
G. I. Serik ◽  
...  
Keyword(s):  
Russian Federation ◽  
Visual Display ◽  
Medical Organization ◽  
Pediatric Hematology ◽  
National Medical ◽  
Oncology Service ◽  
Telemedicine Consultation ◽  
The Subject ◽  
The Russian Federation ◽  
Power Point

The purpose of the study was to create a certification of the service of pediatric hematology-oncology of the constituent entities of the Russian Federation (RF) using infographics and digitalization. Materials and methods. For the first time, infographic maps were used as a tool for certification, as a way of visualizing a large amount of data on the organization of pediatric hematology-oncology service in each subject of the RF. They allowed to show the specifics of the medical and organizational structure of the profile service in the subjects of the RF, their interaction with other subjects and federal centers. Processing of the cartographic image of the subject of the RF was carried out in the Adobe Illustrator graphic editor. A modifiable tool for creating infographic maps created in the MS Power Point program, with saving the results in PDF and PNG formats. Results. In the course of the study, a “Passport of Service” was prepared, containing infographic maps of 77 constituent entities of the RF. The maps in a graphic form provide information on resources available in the subject of the RF: a medical organization of the 3rd level with bed structure and the possibility of visualization, its personnel; the number of multicenter protocols and clinical guidelines used in the subject of the RF; logistics of patients, taking into account the territorial distance from the specialized beds, the presence in the region of the station/department of blood transfusion; the possibility of radiotherapy in the region; the presence of institutions where they provide palliative and rehabilitation assistance; the name of the federal and regional specialized centers, with whom the interaction is carried out, the well-established telemedicine consultation system with the Dmitry Rogachev National Medical Research Center of Pediatric Hematology, Oncology and Immunology. The database of contacts of the main freelance children’s specialists of hematologists and oncologists of the RF was also updated. Conclusion.Thus, data were collected for visual display and to create specific conditions for developing optimal patient routing schemes and forming proposals for optimizing the service. The obtained “Passport of the Children’s Hematology-Oncology Service of the Russian Federation” can be used in the work of hospitals, scientific centers and professional communities.

scholarly journals FEATURES OF THE DEVELOPMENT OF A LYOPHILIZED INJECTABLE DOSAGE FORM OF THE ORIGINAL ANTICANCER DRUG LCS-1208

2021 ◽  
pp. 102-105
Author(s):  
ILYA GULYAKIN ◽  
ANNA LANTSOVA ◽  
LYUDMILA NIKOLAEVA ◽  
MARIA DMITRIEVA ◽  
NATALIYA OBOROTOVA ◽  
...  
Keyword(s):  
Freeze Drying ◽  
Dosage Form ◽  
Freezing Temperature ◽  
Antitumor Drug ◽  
Secondary Drying ◽  
Filter Unit ◽  
Series Of Experiments ◽  
Drying Chamber ◽  
Injectable Dosage

Objective: Development of a lyophilized injectable dosage form LCS-1208, an original antitumor drug based on an indolocarbazole derivative. Methods: The prepared solution of the injectable dosage form LCS-1208 is transferred to sterilizing filtration, which is carried out under vacuum on a «Stericup» filter unit with a filter pore size of 0.22 μm. The sterile solution of the injectable dosage form LCS-1208 is poured into sterile vials using a dispenser and lyophilized in a freeze-drying chamber. At the end of drying, the preparation is corked in the chamber of a sublimation unit using a hydraulic device and transferred to crimping with aluminum caps using a seaming machine. Quantitative determination of the drug content was determined by spectrophotometry using a standard sample at λ = 320±2 nm. The pH was determined by potentiometry. Results: A freeze-drying regimen for the injectable dosage form LCS-1208 has been developed. The required solution freezing temperature was established taking into account the presence of 2 eutectic zones: a solution of LCS-1208 in DMSO (-35 ÷-32) °С, an aqueous solution of Kollidon 17PF (-10 ÷-8) °С. As a result of a series of experiments, the optimal lyophilization regime was chosen that does not require preliminary freezing in a low-temperature chamber, with freezing on the shelves of freeze-drying at a temperature of-47 °C without their preliminary cooling. The most acceptable vial filling volume was determined, amounting to 3 ml, and the rate of temperature rise during secondary drying of the preparation was justified. When using the developed regime of lyophilization of the LCS-1208 solution, it was shown that it can be sublimated while preserving the initial qualitative and quantitative characteristics. Conclusion: In this article, using the example of creating a lyophilized injectable dosage form LCS-1208 (the original antitumor drug from the indolocarbazole group), the main problems that arose during the lyophilization of the selected composition of the model solution, as well as ways to improve the process.

scholarly journals Pharmacokinetic and analgesic properties of the injectable dosage form of a new imidazobenzimidazole derivative RU-1205 with kappa agonist activity

2015 ◽  
Vol 61 (5) ◽  
pp. 636-639 ◽  
Author(s):  
A.A. Spasov ◽  
L.A. Smirnova ◽  
O.U. Grechko ◽  
A.I. Raschenko ◽  
D.M. Shtareva ◽  
...  
Keyword(s):  
Analgesic Effect ◽  
Dosage Form ◽  
Subcutaneous Administration ◽  
Relative Bioavailability ◽  
Agonist Activity ◽  
Hot Plate ◽  
Kappa Agonist ◽  
Pharmacokinetic Properties ◽  
Injectable Dosage

Pharmacokinetic properties of imidazobenzimidazole derivative compound RU-1205 were investigated after subcutaneous administration to rabbits as a substance and a dosage form (lyophilisates for injection) at a dose of 25 mg/kg. The lyophilisate was characterized by high values of the relative bioavailability. In tests, the “hot plate” and “vinegar cramps” the dosage form and the substance exhibited the same analgesic effect.

scholarly journals Emotional Personality Characteristics of Patients Diagnosed with Meningioma with Severe Post-Traumatic Stress

2018 ◽  
Vol 7 (4) ◽  
pp. 150-167
Author(s):  
N.E. Kharlamenkova ◽  
O.S. Zaitsev ◽  
D.A. Nikitina ◽  
A.N. Kormilitsyna
Keyword(s):  
Traumatic Stress ◽  
Social Contact ◽  
Personal Characteristics ◽  
Psychological Consequences ◽  
Post Traumatic Stress ◽  
Basic Assumptions ◽  
National Medical ◽  
Life Threatening ◽  
Post Traumatic ◽  
The Russian Federation

The results of the study on post-traumatic stress rates and individual indicators arising in response to the diagnosis of a life-threatening disease are being analyzed. The participants of the study are the patients of Burdenko National Medical Research Center of Neurosurgery, Ministry of Health of the Russian Federation (n = 25) diagnosed with meningioma. It has been shown that one of the psychological consequences of the diagnosis of “meningioma” is post-traumatic stress of different intensity rates. Increased depression, shyness and emotional lability are associated with high post-traumatic stress rates. The comparison of the triad of emotional-personal characteristics, social support indicators (according to the Psychological Safety Questionnaire) and basic assumptions (according to the World Assumptions Scale) made it possible to verify the research hypothesis. It has been revealed that high rates on depression and shyness scales (according to the Freiburg Personality Inventory) do not reflect the tendency to avoid social contact, but indirectly indicate the presence of auto-aggression or introverted orientation directed to oneself in people diagnosed with this disease.

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