Avaliação da viabilidade tecnológica de obtenção de forma farmacêutica sólida contendo altos teores de produto seco por aspersão de Eugenia punicifolia (HBK) DC

Abstract

Eugenia punicifolia is a species commonly known as pedra-ume-caá, widely used in the Amazon region, especially against glucose disorders, so it is essential the characterization for the establishment of parameters which are used for identification and determination of physico-chemical properties of raw material plant, as well as the development of an extractive solution with defined chemical and technological parameters. The objective of this study was to evaluate the technological feasibility of produce solid dosage form, containing high levels of spray dried extract product (PSA), prepared from an aqueous solution of Eugenia punicifolia. For this, the raw plant, consisting of leaves, was characterized using techniques described in the Brazilian Pharmacopoeia and official codes. The extractive solution was obtained by the method of infusion with a ratio of drug:solvent 7.5% w/V, it was characterized by dry residue. The extractive solution was dried using spray drying technique, without and with pharmaceutical adjuvants in order to improve operational efficiency and technological characteristics of the products obtained. The tablets were produced with granules of PSA (GPSA) obtained by dry granulations with three different concentrations 30%, 50% and 70% of PSA and co-processed adjuvants (GRADJ) produced by wet granulation with filler/binder and disintegrant. The formulations were composed of GPSA (71.4%), GRADJ (28.1%) and lubricant (0.5%). Tablets were produced on instrumented rotary compressing machine. The formulations showed viability of production of tablets, considering its mechanical properties adequate, uniformity of content and rapid dissolution.