Effect of thermal curing of the ethyl cellulose film on the rapidity of release of diclofenac
sodium from pellets
GRYCZOVÁ E.1, RABIŠKOVÁ M.1, TOMÁŠEK V.2, PROKOPOVÁ A.2, CEPÁKOVÁ L.
1Veterinární a farmaceutická univerzita Brno, Ústav technologie léků 2Zentiva a.s., Praha |
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Summary:
Coated pellets controlling drug release are a very popular dosage form which is widely used in
medical practice. At present the coatings of water-insoluble polymers formed from aqueous
dispersions are preferred. However, film formation from an aqueous polymeric dispersion is
different from that from their organic solutions. A stable film on the pellets surface is produced
by coalesces of discrete latex particles at an optimum temperature. The present experimental
paper studied the changes of diclofenac sodium dissolution profiles from coated pellets, when
their coatings from an aqueous polymeric dispersion of ethyl cellulose were cured for different
time periods (1–72 hours) and a temperature of 60 °C. Drug release rate was decreasing with the
increasing time of the layer curing up to 24 hours. At this time the dissolution curve was similar
to a strait line. When the curing time further increased, the drug release was again faster. All
prepared samples (with or without seal coat, cured for a period of 24 hour or uncured) were
filled into hard gelatine capsules and stored in blisters in three different stability boxes
(25 °C/60 % RH, 30 °C/65 % RH, 40 °C/75 % RH) for 6 or 12 months. The best drug dissolution
profile and stability were observed for the pellets with the seal coat and ethyl cellulose coating
cured for 24 hours.
Key words:
pellets – water dispersion of ethyl cellulose - curing – drug dissolution profile –
stability
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