Pharmaco-technological researches for development of tablets composition with amlodipin and enalapril
Ukraine has one of the highest mortality rates from cardiovascular diseases in Europe, accounting for 772.1 cases among men and 440.9 among women per 100 000 population.
Antihypertensive drugs are different in dose, active substance and mechanism of action. Monotherapy is ineffective in most cases, therefore it requires a combination of several substances from different pharmacotherapeutic groups. Enalapril and amlodipine are the most often included in treatment regimens for hypertension. Therefore it is advisable to develop combined tablets with enalapril and amlodipine.
The aim of the work was to study the effects of excipients on the pharmaco-technological parameters of intermediates and tablets with enalapril and amlodipine.
During the work the studied excipients were grouped into 6 factors according to their functional purpose. The experiment was based on the method of mathematical planning. The tablets were preparated by compression after wet granulation. The studies were carried out according to pharmacopoeial methods. Statistical data processing was performed by dispersion analysis.
During the experiment it was studied the effects of 30 excipients on the pharmaco-technological properties of granules (loss on drying), tablet mass (fluidity, angle of inclination, bulk density, tapped density) and tablets (uniformity of mass, hardness, friability and disintegration). The effect of 6 qualitative factors on the main reviews (indicators) of granules, powder masses and tablets with enalapril and amlodipine was studied. It is showed by ranked rows of advantages for the influence of excipients on 10 reviews (indicators) of granules, powder masses and tablets with enalapril and amlodipine.
As a result of the study, the effects of excipients on the pharmaco-technological parameters of intermediates and tablets with enalapril and amlodipine were studied.
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