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Aqueous enteric coating of diclofenac sodium in a fluiidized bed coater column with a Wuster insert

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Author(s):
Roberta Albanez
Total Authors: 1
Document type: Master's Dissertation
Press: Campinas, SP.
Institution: Universidade Estadual de Campinas (UNICAMP). Faculdade de Engenharia Química
Defense date:
Examining board members:
Osvaldir Pereira Taranto; Sandra Cristina dos Santos Rocha; Wanderley Pereira de Oliveira
Advisor: Marcello Nitz; Osvaldir Pereira Taranto
Abstract

Pellets have many biopharmaceutical advantages and are suitable for coating. When the coating is performed for functional purpose, one of the major goal is to form a barrier that modifies the drug release profile (controlled or enteric release). In this work, diclofenac sodium pellets were produced by the extrusion / spheronisation process and then coated in a fluidized bed coater column with a Wurster insert. This type of bed is one of the best suited systems for the coating of particles. One of the main advantages is that it avoids dead zones. This work aimed to study the coating of pellets produced with two commercial aqueous enteric polymer suspensions, Advantia® Performance and Acryl-Eze® MP. The study of the coating process was accomplished through a 2³ experimental design. The variables studied were: inlet air temperature, suspension flow rate and coating polymer. The response variables were: process efficiency, results above 78.2%, and agglomeration fraction, values below 8%. The effect of polymer coating type was the variable that influenced the response variables the most. The polymer Advantia ® Performance resulted in a better efficiency and increased the agglomerate fraction. The minimum mass gain to achieve the enteric profile was also determined - Acryl-Eze® MP: 9.7% and Advantia® Performance: 8.6%. The coated pellets were tested for content, dissolution and stability. In the stability test, pellets coated with Advantia® Performance maintained the enteric profile. However, the pellets coated with Acryl-Eze® MP presented a better enteric profile after the exposure to conditions of stability, which may indicate that coalescence of the polymer particles occurred during storage. The suspensions were characterized by rheology and contact angle. The static wettability of the polymeric powder was also tested (AU)

FAPESP's process: 09/11834-4 - Comparison of diferents commercial polimers used in coating of controled release pellets
Grantee:Roberta Albanez Toreta
Support Opportunities: Scholarships in Brazil - Master