Development of the technology of tablets on the basis of ademetionine 1,4-butanedisulfonate
Keywords:1, 4-ademetionine butanedisulfonate, direct compression, granulation, humidity
During medicinal product development a lot of key points should be taken into consideration. The purpose of pharmaceutical development is not only the creation of effective and safe preparation but also the organization of appropriate conditions for the process of production that could provide its recovery rate.
The choice of optimized composition for medicinal product and the development of technology help to define the interval of allowed parameters’ values of the process and subcomponents of the recipe, following of which guarantees correspondence of the final product to the specification limit .
Objective. To develop technology for the production of film-coated tablets based on 1,4-ademetionine butanedisulfonate, which corresponds to the given specification.
Materials and methods. Wet and dry granulation structure was used in the development of methods. Bulk density, flow ability and the angle of deflection were determined in the prepared mixtures. Formulation was analyzed in all parameters according to the specifications, including the examination of options such as decay, dissolution, abrasion and crush resistance.
Results. The technology and definitive conditions for preparation on the basis of the ademetionine 1,4-butanedisulfonate substance were created and selected. Next criteria of optimization have been defined: flow ability, bulk density for performing and also crush resistance, friability and disintegration of ready pills. Critical value is humidity of the substance that influences the quality of the production and requires appropriate production conditions.
Conclusions. On the basis of studying of the influence of relative degree of humidity and pressing efforts on the factors that were mentioned above it was established that the most rational method of getting the pills is performing with previous granulation of a mass. By means of physical-chemical (flow ability, bulk density, angle of deviation) and technological (resistance to crushing, abrasion, dissolution and disintegration) research methods, it was proved that this technology allows to obtain tablets that are fully compliant with specifications for the tablets covered with an enteric coating.
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