Tablet formulation study of spray-dried sodium diclofenac enteric-coated microcapsules.
Sodium diclofenac enteric-coated microcapsules were prepared by a spray-drying technique with Eudragit L 30D as enteric-coating material. The spray-dried powder, mixed with neocel or flo-starch, or the mixture of neocel and flo-starch (weight ratio, 1:1) was directly compressed into a tablet. The micromeritic properties of the spray-dried powder and the mixed powder for tableting were investigated. The flowability of the spray-dried powder was poor but improved after incorporating the excipients. The release rates of sodium diclofenac from the spray-dried powder, the mixed powder before tableting, and the tablets were determined in 0.1 N HCl solution, pH 6.8, phosphate buffer solution, distilled water, and pH-changed medium. The results indicated that the spray-dried powder, the mixed powder before tableting, and the tablets all exhibited enteric-coated release properties; these powders and tablets showed some resistance to stimulated gastric acid and then released drug more rapidly in pH 6.8 buffer solution. The weight ratio of neocel to flo-starch plays an important role in controlling the release of sodium diclofenac from enteric tablets. The 1:1 weight ratio of neocel to flo-starch was more suitable for designing the microdispersed sodium diclofenac enteric-coated tablets.
Department of Medical Research, Veterans General Hospital-Taipei, Republic of China.
S Y
SY
Lin
Y H
YH
Kao
D000179:Acrylates; D002214:Capsules; D004008:Diclofenac / Q000008:administration & dosage / Q000737:chemistry*; D006863:Hydrogen-Ion Concentration; D008855:Microscopy, Electron, Scanning; D011208:Powders; D012995:Solubility; D013213:Starch; D013608:Tablets, Enteric-Coated
D000179:Acrylates; D002214:Capsules; D011208:Powders; D013608:Tablets, Enteric-Coated; D004008:Diclofenac; D013213:Starch