2013 - Renata Longhini
Ph.D. Thesis
Author: Renata Longhini
Postgraduate Program in Pharmaceutical Sciences - State University of Maringá
Area of Knowledge: Pharmacognosy
Date of Defense:February 28, 2013
Advisor: Prof. Dr. João Carlos Palazzo de Mello
Examination Board: Prof. Dr.Luis Alexandre Pedro de Freitas
Prof. Dr. Pedro Ros Petrovick
Prof. Dra Selma Lucy Franco
Prof. Dra. Gisely Cristiny Lopes
Title: Development of solid pharmaceutical dosage form containing dried extract by sprinkling of Trichilia catigua
Abstract: The interest in medicinal plants and the knowledge of their biological activities continues rising and promising. Even with the advancement of traditional therapy, the appeal to nature and the search for alternative therapies is evident, therefore medicinal plants remain in focus. Natural products still represent a valuable source for production of new chemical compounds. Among the herbal drugs Brazilian biodiversity, the Trichilia catigua A. Juss., Popularly known as catuaba, has been widely used by the population as a tonic for the treatment of fatigue, stress, impotence and memory deficits. Studies confirmed activity as antibacteria, trypanocidal, anti-inflammatory, antidepressant and memory, and also have antioxidant than vitamin C and trolox. It is reported that the chemical constituents responsible for most of of these activities are phenolic compounds, mainly tannins, which are found in abundance in the bark of this plant. To evaluate the quality of extracts was developed a method by high performance liquid chromatography (HPLC) for quantification of procyanidin B2 (PB2), epicatechin (EPC), cinchonains Ia, Ib, IIa and IIb, catechin and chlorogenic acid in acetate fraction acetate (MEF) obtained from the bark of T. catigua. The method consists of a gradient elution system with as mobile phase methanol: acetonitrile (75:25, v/v) and water, both acidified with 0.05% trifluoroacetic acid, varying the proportion of the organic phase of 30 to 40% in 36 min, reestablishing the system. The column used was a Luna PFP (2), with a flow of 0.4 mL / min and at 280 nm. The validation process demonstrated that the method was linear, precise, accurate, robust and stable, and is useful for quality control T. catigua and the finished product. In order to improve the technological characteristics of FAE, 11 spray-drying extracts were developed, containing 70% of the FAE and 30% of a binary mixture of adjuvants drying: colloidal silicon dioxide (CSD), maltodextrin (MALT) and lactose (LACT), in different ratios between them. The best extracts were batches L10 (CSD:LACT, 50:50) and L11 (CSD:LACT, 75:25) for the production of tablets by direct compression, were characterized according to their visual appearance, hardness, friability, disintegration, dissolution and content, results are in agreement with pharmacopoeial specifications. The dissolution and release profile were evaluated, the dissolution media was varied. The tablets proved to be suitable for production.
Keywords: Trichilia catigua, analytical validation, spray dried extract, tablets, dissolution profile.
Thesis PDF: Renata Longhini
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