The choice of fillers when creating natural zeolite tablets by the wet granulation method
Keywords:natural zeolite, clinoptilolite, tablets, excipients, fillers, wet granulation
Tablets are one of the most popular among all pharmaceutical dosage forms. Properties of tablets depend on a number of factors; the content of excipients is the most important of them. Among the complex of excipients of different functional orientation fillers, which can significantly affect the technological properties of tablets, in particular, hardness and friability of tablets, occupy a special place.
Aim. To to select the optimal qualitative composition of fillers for obtaining natural zeolite tablets by the method of wet granulation.
Materials and methods. The objects of research were natural zeolite tablets (10 mm in diameter) obtained by pressing with the preliminary wet granulation. Model samples contained various fillers, which were the combination of lactose with microcrystalline cellulose (MCC), sorbitol and powdered sugar. A balanced single-factor experiment with equal duplication of experiments was used to select the optimal composition of excipients. Four quantitative factors were studied. The quality of the tablets was assessed by the indicators of uniformity of mass, hardness, friability and disintegration time. In the experiments the modern equipment was used. To conduct the tests the methods of the State Pharmacopoeia of Ukraine (SPhU) were used.
Results and discussion. As a result of the analysis of the data obtained it has been found that both the type and concentration of fillers affect the pharmaco-technological properties of tablets. The studies conducted showed that among the types of fillers studied, including mixtures of lactose with MCC, sorbitol and powdered sugar in different proportions, the best results according to four technological factors, namely uniformity of mass, hardness, friability and disintegration time of tablets, were demonstrated by the combination of lactose with MCC in the ratio of 1 : 1. It was this combination that we chose for further research to create natural zeolite.
Conclusions. The studies on selection of the qualitative composition of fillers for creation of natural zeolite tablets by pressing with the preliminary wet granulation have been performed, and the optimal composition of fillers has been proposed to provide the production of tablets which properties correspond to the current requirements of the SPhU.
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