SELECTION OF QUANTITATIVE COMPOSITION OF EXCIPIENTS FOR CREATION TABLETS «ANGIOLIN»
DOI:
https://doi.org/10.11603/2312-0967.2016.4.7114Keywords:
angiolin, excipients, tablets, wet granulation, quantitative factors.Abstract
Introduction: Every year there are about 9.4 million people who die from cardiovascular diseases. Among them, 51% of people dying from a stroke, and 45% - from coronary heart disease. Cardiovascular diseases are called the problem number one in the world today, including Ukraine. Annually cardiovascular disease kills more than 500 thousands of Ukrainians, that is, on average, 1,370 people die every day. According to the State Statistics Service, in 2016 about half of deaths in Ukraine were caused by cardiovascular diseases. In comparison with 2015 the number of death rates have not changed in Ukraine. This shows a low culture of prevention, diagnosis and treatment of cardiovascular disease among Ukrainians[7,9,10].
For the last three years the cardiovascular diseases make up 66% in general Ukrainian structure of mortality, while in most European countries, this figure does not exceed 50%.
Materials and Methods
In quantitative formulation development of "Angiolin" tablets we used an active substance - angiolin substance and several excipients[1].
Substance of angiolin (Series number 8 manufacturer Public Factory "Chemical plant", Kharkiv) was derived by SPA "Farmatron" according to agreement of joint research. The excipients that were used for “Angiolin” tablets, are certified and produced in Ukraine and abroad[2,3].
In studies we used the latest and modern equipment: tableting press, uniformity tester for tablet mass determination, tester for tablet friability, hardness, and disintegration time determination.
The 5 quantitative factors were studied during studies.
Results and discussion
The amount of calcium stearate was 1 % while tablet formulating, in stage of granules lubrication. When according to the experiment plan the average “Angiolin” weight was less than 0.32 for the required dose number, we added MCC 101, which previously showed the best results.
Analysis of regression equation has shown that the disintegration time of “Angiolon” increases in cases of multiplying of the microcrystalline cellulose (MCC) burst 200 on the granules lubrication stage and of MC 15 concentration of solution. Note that only in the experiment number 5, the disintegration time of obtained "Angiolin" tablets was more than 10 minutes. The disintegration time of tablets decreases in cases of multiplying of the MCC burst and the amount of croscarmellose sodium and sugar powder increases[4,5,6].
The conducted studies have shown that “Angiolin” tablets were obtained in 5 of the 8 series of experiments and the hardness was 50 H, disintegration time was less than 10 minutes. The additional studies have been conducted by " steepest ascent " method to the optimum, resulting in optimal “Angiolin” formulation. The tablets of chosen quantitative formula meet all current pharmacological and technological requirements of State Pharmacopoeia of Ukraine[8].
Conclusions:
1. The research of quantitative formulation of components for "Angiolin" tablets by wet granulation was made.
2. As a result of additional studies by " steepest ascent " method to the optimum we proposed the "Angiolin" tablet formula which consists of 0.2 of angiolin, 0.0256 of castor sugar, 0.0256 of MCC durst, 0.0256 of сroscarmellose sodium, 0.0336 of MCC 101, 2% of MC 15 solution, 0.0032 of calcium stearate, 0.0064 of MCC 200. Obtained tablets meet all pharmacological and technological requirements of State Pharmacopoeia of Ukraine.
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