Dry coating: an innovative enteric coating method using a cellulose derivative.
A novel enteric coating method was developed. This method involves direct feeding of coating polymer powder and simultaneous spraying of plasticizing agent, without either organic solvent or water, using a centrifugal granulator, fluidized bed, or tablet-coating machine. For film formation, a curing step was then necessary; this involved spraying a small amount (3-8% of core weight) of water or hydroxypropyl methylcellulose solution, followed by heating. Hydroxypropyl methylcellulose acetate succinate was used as the enteric coating polymer, and a combination of triethyl citrate and acetylated monoglyceride was used for plasticization. The coated beads and tablets were evaluated for gastric resistance, intestinal disintegration, and stability, in comparison with beads and tablets from a conventional aqueous coating with the same enteric polymer. The new method required a higher coating amount for gastric resistance compared with the conventional coating, but the processing time was dramatically reduced. The results show that this dry coating method is applicable to the preparation of enteric-coated beads and tablets using commercially available lab-scale apparatus.
Obara
S
S
Specialty Chemicals Research Center, Shin-Etsu Chemical Co., Ltd., Niigata, Japan.
Maruyama
N
N
Nishiyama
Y
Y
Kokubo
H
H
D004355:Drug Stability; D008747:Methylcellulose / Q000031:analogs & derivatives*; D008855:Microscopy, Electron, Scanning; D008863:Microspheres; D010316:Particle Size; D010968:Plasticizers; D011208:Powders; D013608:Tablets, Enteric-Coated
D010968:Plasticizers; D011208:Powders; D013608:Tablets, Enteric-Coated; C048331:hydroxypropylmethylcellulose acetate succinate; D008747:Methylcellulose