Analysis of coated microparticles in a small-scale fluid-bed.

BRIGNONE SOFÍA G; RAVETTI SOLEDAD; PALMA SANTIAGO D

Mar del Plata

Otro; Reunión Anual de sociedades de biociencia. SAIC. SAFE. SAB. SAP. AACYTAL. NANOMED-ar.; 2019

Sociedad Argentina de Farmacología Experimental

INTRODUCTIONThe design of multiparticulate systems is a technological strategy of high impact in the formulation ofimmunomodulators for the oral route, being the fluid bed coating an attractive obtaining method, due to itsversatility and relatively low cost, allowing that substances such as the cell wall of Saccharomyces cerevisiae(EPL), can be transported in low concentrations together with delayed release products. The objective of thiswork was to coat a solid support (SUGLETS®) with EPL and with an aqueous acrylic enteric system (Acryl-EZE®) to subsequently evaluate the way in which the active component is liberate of the system, through invitro dissolution tests.METHODSThe design and development of the microparticles (MP) was carried out in a Caleva Mini Coater Drier -2 unit.The influence of the operating and formulation conditions on the quality and performance of the SUGLETS®coated by EPL was determined through a fractionated factorial design. Then, the MP were coated with Acryl-EZE® and in vitro dissolution tests were performed to determine the effectiveness of the film coatings and theway in which the active component is released from the system using a Semi-automatic Dissolution System TXtendTM, Apparatus 1 (basket) and Ultraviolet?visible Spectroscopy.RESULTSThe conditions that resulted in the best performance (93%) and gain in weight (42%) were from the equipment:FAN: 14.1 m/sec, Temperature: 26°C, Pump: 1.15rpm, Pressure: 20psi. and from Formulation: EPL: 1gr,Methocel: 0.2gr, DS: 1 gr, Glycerin: 2gr.The conditions in relation to the dissolution test: In the acid phase: 0-120 minutes, not more than 10% dissolvedand buffer phase: 120-210 minutes, not less than 80% dissolved.DISCUSSION & CONCLUSIONSBy means of the use of a fluidized bed, it was possible to obtain microparticles coated with immunomodulatorycompound (EPL) which, after coating with an enteric film coating, it was possible to determine the delayedrelease by colorimetric reaction.