Manufacture of Slow-Release Matrix Granules by Wet Granulation with an Aqueous Dispersion of Quaternary Poly(meth)acrylates in the Fluidized Bed

Abstract

Slow-release matrix granules were manufactured in the fluidized bed using an aqueous dispersion of quaternary poly(meth)acrylates (Eudragit RS 30 D) as binder for granulation. A factorial design was carried out to investigate the influence of the following parameters, spraying rate, applied polymer amount, and inlet air temperature, on various granule properties. Prerequisites for a slow release of the model drug theophylline are high spraying rate, high amount of polymer, and low inlet air temperature. No considerable decrease of the drug release rate can be achieved without a subsequent curing of the dry granules. A clear correlation exists between the moisture content of the fluidized bed, indicated by the terminal moisture content (TMC), and the mean dissolution time for 80% of the drug (MDT80).

Slow release drug dissolution profile prediction in pharmaceutical manufacturing: A multivariate and machine learning approach

“…A typical batch manufacturing process for time-release drugs involves granulation [8] of the raw materials, extrusion and spheronization of the resultant mix to form microspheres (referred to as spheroids or pellets) [6], drying and sieving [9], coating of the spheroids with an insoluble layer and finally encapsulation. The dissolution profile of the final product must meet target specifications with regard to the amount of drug released over time.…”

Development and evaluation of long-acting epidural “smart” thermoreversible injection loaded with spray-dried polymeric nanospheres using experimental design

“…These methods comprise co-agglomerating drugs and aqueous polymeric dispersions employing fluidized bed granulation (Radtke et al, 2002) or using spray drying technique (Hegazy et al, 2002) and then forming monolithic matrix systems.…”

Revestimento de partículas por solidificação de material fundido em leitos de jorro e fluidizado: estudo do processo, caracterização das partículas e preparo de comprimidos

“…67 Tabela 14 -Interpretação do índice de Carr para a fluidez de pós (adaptado de WELLS, 1988 FRANZ, 1990;NIEBERGALL, 1996;ACHANTA et al, 1997;SASTRY;KHAN, 1998;RAMBALI et al, 2001;RAMBALI;BAERT;MASSARD, 2001b;GAO et al, 2002;RADTKE;KNOP;LIPPOLD, 2002;KRAMAR;TURK;VRECER, 2003;DIAS;PINTO, 2004).…”