Frederico S. E-mail: moc. Abstract Instruction: Despite the increased use of Brosimum gaudichaudii roots as raw material on medicine to treatment of vitiligo, there are not studies that showing the impact of unit operations on the quality and standardized of the extract of B. The quality of the herbal extract is essential to ensure the safety and efficacy of pharmaceutical product. Due the medical and commercial importance, this study aimed to evaluate the impact of the extraction method ultrasound or percolation on the quality of herbal extract and optimize the extraction of psoralen and 8-methoxypsoralen 8-MOP from B.
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E-mail: moc. There is a shortage of solid oral dosage forms developed from standardized extracts of this plant specie. Objective: This study is aimed to obtain pellets with a standardized liquid extract of B.
Results: The standardized liquid extract of B. Pellets were obtained through a mixture of extract of g of B. These pellets were coated with a suspension composed of titanium dioxide, aluminum red lacquer, ethyl cellulose, talc and magnesium stearate. Before the photostability test, the uncoated pellets showed psoralen content equal to 0.
After exposure to one level 3 J. After exposure to three levels 10, 20 and 30 J. The coated pellets where unaffected after photostability test. Conclusion: Pellets were obtained with the standardized liquid extract of B. Moraceae roots, is tradionally used in Brazil for the treatment of patients with vitiligo, this effectiveness is attributed to the psoralens, psoralen and 5-methoxypsoralen 5-MOP.
Neurohumoral imbalances and states of oxidative stress are also associated with the expression of vitligo. They conclude that the extract with higher levels of psoralens is more toxic.
However, Cunha et al. Until now the therapeutics dosage for this plant, extract has not been stated based on the contents of the psoralens. Despite being promising the authors did not find reports available on studies related to the technological aspects regarding the preparation of solid dosage forms containing the extract obtained from the roots of B. The use of pellets obtained by extrusion-spheronization is an interesting approach to the incorporation of this plant extract into solid dosage forms.
Pellets are classified as a multiparticulate drug delivery system with many related biological advantages. In this study, the standardized extract of B. The roundest pellets with a large amount of the extract were selected for the coating process.
The characteristics of the pellets and photostability of psoralen and 5-MOP have been determined and compared. Methods Extraction procedure B. The macerated material underwent percolation with free flow of the extract. The extract was collected and re-percolated, this process was repeated five times. Empower 2. The detection wavelength was set at nm for psoralen and nm for 5-MOP. Pellets formulation The wet mass was obtained by two different ways. In the first moment the powdered material were manually shaken during 15 min and then transferred to a bowl to wet granulation process.
The powder and the granulation liquid were homogenates after 15 min of hand kneading. This process was performed until the optimal formula was obtained for scale-up process. The amount of each component was determined experimentally. Extrusion and spheronization procedure The wet masses was manually fed into the extrusion chamber and compressed against the extrusion plate at a speed of 35 rpm.
The extrudates were spheronized in a cross-hatched plate with g of load, at rpm for 5 min or at rpm for 6 min. Coating of pellets The coating suspension was obtained sitirring in mL of water, 6.
Separately, while continuously stirred until completely dispersed, 3. The pellets were placed as a monolayer. The identification and quantification of psoralen and 5-MOP were performed with chromatographic methods previously described. The extraction procedure of psoralen and 5-MOP were performed with 15 mg of coated or uncoated pellets, crushed with mortar and pestle. The crushed material was standardized by size separation with a mesh sieve.
This powder was transferred to an Erlenmeyer flask with 10 mL of methanol and subjected to ultrasonic bath during 20 min. After that, the contents inside of the flask were centrifuged at rpm for 10 min. The precipitated material was separated from the supernatant, and the extraction process was repeated. From the samples obtained aliquots of 1 mL were collected, filtered through a 0. For the photostability test, the values of the reaction rate constant k was determined by the straight linear equation, attributing the angular coefficient a corresponding to the k value.
All analyzes were performed in triplicate. The aspect ratio, Feret diameter, and shape factor eR were determined using the freeware ImageJ to process the images. The SEM- EDS Energy-dispersive spectroscopy were used to identify cations of aluminum, titanium and magnesium in the coated pellets surface. The percentage recovered of the psoralen was equivalent to The method has a limit of detection and quantification for psoralen equal to 0. The values obtained with the system suitability test are in accordance with international official parameters.
The hydroalcoholic extract possessed a pH of 5. The content of psoralen and 5-MOP in the hydroalcoholic extract of B. During the stages of development of new pharmaceutical product, the first trials are conducted parsimoniously to ensure that the material used is not wasted and more information about it is generated. As a result, the BG1 formula [ Figure 1 ] was obtained only with microcrystalline cellulose and hydroalcoholic extract of B. The microcrystalline cellulose is the most popular excipient used in the production of pellets because it increases plasticity contributing for the formation of spherical shape in pellets and exhibited a weak natural adhesiveness.
According to Shah et al.