scholarly journals Preparation of 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and development of quality control methods

2021 ◽  
Vol 10 (2) ◽  
pp. 62-67
Author(s):  
A. M. Domanina ◽  
M. V. Chernikov ◽  
I. P. Remezova ◽  
E. F. Stepanova ◽  
A. M. Shevchenko ◽  
...  

Introduction. Currently, for the treatment of gastric ulcer, drugs with a combined effect are used. To eliminate possible side effects of the drugs used, the search for new molecules to create more effective and safe histamine H2 receptors continues. As a possible solution to these problems, we investigated the substance dinitrate of 2-phenyl-9-diethylaminoethylimidazo[1,2-α] benzimidazole (DFDB).Aim. The aim of this study was to obtain 2-phenyl-9-diethylaminoethylimidazo[1,2-α]benzimidazole dinitrate tablets and develop methods for quality control.Materials and methods. The object of study was tablets based on the substance DF DB. The physicochemical and technological properties of the tablet dosage form were studied. Pharmaco-technological and physico-chemical indicators were determined according to the methods of the State Pharmacopoeia of the XIV edition. Identification and quantitative determination of DFDB in tablets was performed by HPLC.Results and discussion. Based on the physico-chemical properties and determination of the main technological indicators of DFDB, an optimal tableting technology has been developed. The optimal composition of tablets has been developed. Identification of tablets is proposed to be carried out using HPLC in comparison with the standard sample of DFDB. Related impurities, according to the data obtained, do not exceed 0.1 %. We found that the tablets do not have an antimicrobial effect. The analyzed tablets correspond to category 3A. The content of DFDB should be from 95 to 105 % of the declared amount in one tablet. During the analysis, we conducted biopharmaceutical and technological studies of the finished dosage form during storage under the conditions of long-term stability testing in polymer cans with screw-on lids. It is shown that the selected composition of excipients and the production technology ensure the stability of the finished dosage form for two years of storage under the observed conditions. To select the tableting technology, the main technological properties of the DFDB substance are analyzed. The choice of excipients and the composition of the film coating was carried out.Conclusion. The technology is developed and standardization of tablets based on the substance DFDB is proposed.

2018 ◽  
pp. 71-78
Author(s):  
I. V. Kovalevska ◽  
O. A. Ruban

Characteristics and relevance of article topic. Analysis of the literature data shows that the thioctic acid preparations are widely used in the treatment of various diseases. At it’s parenteral application inter- and intraindividual level at the plasma can vary significantly. Therefore, the bioavailability of thioctic acid according to the results of clinical researches is only 30% and efficacy largely dependent on the technological features of the dosage form manufacturing process. The goal of paper was researches of the thioctic acid physico-chemical properties for development of composition and technology of solid dosage form with improved bioavailability. Thioctic acid was the object of the study. The complex of physical, chemical and technological tests were used during researches: microscopic, thermal analyzes studies of bulk density, flowability, compression ratio, hygroscopicity, dissolution. Conclusions. According to thermal analysis, thermal stability of thioctic acid sample has been established within 20–180 °C. The results can be used for explanation the temperature regime in the preparation of solid dispersions of thioctic acid by the melting method. Solubility determination according to SP of Ukraine II-ed. and microscopic method showed that the substance is readily soluble in 96% ethanol, which leads to the conclusion about the possibility of preparation thioctic acid solid dispersions by dissolution method. During researches were established physico-chemical and technological properties of the thioctic acid substance, produced by Shanghai modern pharmaceutical Co., LTD (China). Were established that the substance is hygroscopic as evidenced by the change in appearance and weight. It was determined that the substance does not have a satisfactory yield (Carr index – 1,39, slope angle – 60°), compression ratio is 0,495, which is indicative of the lack of sample strength after the removal of pressure. The results of the studies suggest that the physicochemical properties of the substance needed modifications in the manufacture of solid dosage forms with thioctic acid.


2018 ◽  
Vol 122 ◽  
pp. 702-708 ◽  
Author(s):  
S. Sani ◽  
M.U. Kaisan ◽  
D.M. Kulla ◽  
A.I. Obi ◽  
A. Jibrin ◽  
...  

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
E Mestres ◽  
Q Matia-Algué ◽  
A Villamar ◽  
M García-Jiménez ◽  
A Casals ◽  
...  

Abstract Study question Do commercial mineral oil brands differ in their capacity to stabilize the human embryo culture system, and is this related to the oil’s viscosity? Summary answer While the oils’ viscosity only had minor effects on temperature maintenance, it showed a direct correlation with the stability of pH and osmolality during culture. What is known already Mineral oil is a key component of the in vitro embryo culture system, which stabilizes temperature, pH and osmolality of the media during culture. Its use has been implemented worldwide for several decades and many manufacturers currently produce and commercialize oil intended for human embryo culture. Unfortunately, oil remains as one of the less characterized products in the IVF laboratory due to a lack of standardized nomenclature, production and testing. With differing physico-chemical properties, such as viscosity, oils produced by various manufacturers could behave differently to the same culture conditions and, thus, its use may need to be adjusted accordingly. Study design, size, duration Viscosity was quantified in three high-viscosity (H-V) and three low-viscosity (L-V) oils with a viscosity-meter. The required time for media’s pH to equilibrate using each oil was studied, as well as its subsequent stability outside the incubator for 30min. In-drop temperature was assessed during 15min when taking a dish outside the incubator, and again when putting it back. Additionally, each oil’s capacity to avoid media evaporation was studied with daily osmolality measurements during 7 days. Participants/materials, setting, methods pH equilibration was measured with a continuous pHmeter (Log&Guard, Vitrolife) in 4-well dishes prepared with 600µl of medium and 500µl of oil. For the other experiments, 35mm dishes with 4ml of oil and 20µl media droplets were used. pH stability was assessed after 0, 15 and 30min outside the incubator with a blood-gas-analyzer (epoc,SiemensHelthineers). A fine-gauge thermocouple was used to measure in-drop temperature loss/recovery. Daily osmolality readings were taken with a vapor pressure osmometer (Vapro5600,Wescor). Main results and the role of chance The selected oil samples had a viscosity of 115, 111, 52, 22, 18, and 12cP. The medium’s pH took approximately 12h to completely equilibrate under H-V oils, while it took less than 4h in L-V. Similarly, the rise in pH after 30min on a heated stage outside of the incubator with room atmosphere was 0.03, 0.04, 0.06, 0.13, 0.17, and 0.26, respectively. Dishes were taken out of the incubator and placed on a heated surface. In the first five minutes, the in-drop temperature loss ranged between –0.22 and –0.13oC/min, with no significant differences observed between oil types. However, temperature plateaued at a significantly higher value in L-V oils (36.5oC), compared to H-V brands (36.25–36.1oC; p = 0.0005). By contrast, all samples followed a similar pattern when the dishes were returned to the benchtop incubator, with temperature taking around 7 minutes to completely recover. Some media evaporated in all oil groups during the 7-day culture in a dry benchtop incubator. The linear regression performed to compare the evaporation rate between groups showed a statistically significant correlation between oil viscosity and the rate of evaporation (p < 0.0001), with an osmolality rise ranging between +2.55mmol/kg/day in the most viscous oil and +6.29mmol/kg/day in the least viscous. Limitations, reasons for caution While the selected oils for this study represent a wide range of options in the market, future projects could widen this selection and include additional tests, such as optimized bioassays. Results may vary between centers, and thus each laboratory should test and optimize their culture system with their own settings. Wider implications of the findings: Different oil brands have shown differing physico-chemical properties that have a direct effect on the culture system and the stability of several culture conditions. These results may be of major importance to adapt the settings and methodologies followed in each IVF laboratory according to the type of oil being used. Trial registration number Not applicable


2017 ◽  
Vol II (I) ◽  
pp. 44-55
Author(s):  
Ayesha Sabir ◽  
Syeda Komal Fatima ◽  
Asma Kaleem ◽  
Sidra Altaf ◽  
Imran Khan

This study was conducted to evaluate both the in-process quality control tests as well as the finished dosage form tests for a parenteral product. Furthermore, all the processes from the purchase of API to marketing of product were studied. A batch of Adicovil was taken Adicovil was taken as an example, it is small volume parenteral of 2ml ampoule that is studied to evaluate its efficacy and stability by performing chemical and physical tests. IPQC tests for type I glass includes powder glass test, while for water for injection they are pH, acidity & alkalinity, non-volatile matter, ammonium ions, non-oxidizable matter, sterility and pyrogen test. Test for finished dosage form of Adicovil are identification, leaker test, clarity test, sterility, pyrogen test, BET, deliverable volume and determination of volume of injection for container. The selected batch of Adicovil passed all the IPQC and FDF tests in the procedure.


2013 ◽  
Vol 59 (No. 8) ◽  
pp. 372-377 ◽  
Author(s):  
W. Szulc ◽  
B. Rutkowska

The determination of a range of boron concentration in the soil solution, evaluation of the effect of physico-chemical soil properties on boron concentration in the soil solution as well verification whether boron quantity in the soil solution is sufficient for nutritional needs of selected plants cultivated in Poland were comprised. Average boron concentration in the soil solution of Poland&rsquo;s cultivated soils ranges from 0.59 to 5.07 &micro;mol/L and is differentiated by physico-chemical properties of soil. Taking into account decreasing effects of soil properties on the increase of boron concentration in the soil solution, the soil properties can be arranged as follows: organic C &gt;<br />soil abundance in available boron &gt; soil texture &gt; soil pH. The minimum boron quantity observed in the soil solution of Poland&rsquo;s cultivated soils was not sufficient to fulfil nutritional needs of the plants. The maximum boron quantity observed secured nutritional needs of cereals and potatoes but not those of rape plants and sugar beets. Based on the study it can be concluded that the measurement of the concentration of boron in the soil solution can be used in the diagnosis of deficiency of this element for crops.


2020 ◽  
Vol 20 (sup3) ◽  
pp. S1579-S1589
Author(s):  
Dinesh Chandra Naithani ◽  
J.M.S. Rawat ◽  
Bhupendra Singh ◽  
Vinod Prasad Khanduri ◽  
Manoj Kumar Riyal

1997 ◽  
Vol 500 ◽  
Author(s):  
M. L. Pereira Da Silva ◽  
A. Romanelli Cardoso ◽  
J. J. Santiago-Aviles

ABSTRACTThis work presents the analysis performed on a SiO2 film deposited from organometallic precursors with the aim of correlating their physico-chemical properties including electrical characteristics with processing variables. The characterization tools used in this study included SEM for film homogeneity; SIMS for the determination of total carbon content; FT-MS and Raman scattering spectroscopy for surface characterization. GC-MS was used to understand the electrochemical reactions taking place while performing I-V characteristics measurements.The use of these multiple characterization techniques pointed out to deposited films with reasonable deposition characteristics but poor electrical ones. Phase segregated heterogeneity's rich in carbonatious residues influenced the degradation of the electrical characteristics.


Sign in / Sign up

Export Citation Format

Share Document