Fast dispersible/slow releasing ibuprofen tablets.
Eight formulations were developed containing ibuprofen in the form of orally disintegrating tablets. To prevent bitter taste and side effects of the drug, the drug was associated with Phospholipon 80H, a saturated lecithin, by wet granulation. The granules were then coated using different film forming agents (Kollicoat SR 30, Amprac 01, Kollidon 90F, Eudragit RD 100) obtaining four lots 1-4. Coated granules were then formulated with a sweetener (Aspartame), a mannitol-based diluent (Pearlitol SD 200) and Kollidon CL (1-4K) or Explotab (1-4E) were added as superdisintegrants and compacted under low compression force. The eight lots of tablets, 1-4K and 1-4E, were assessed if suitable as oral disintegrating tablets by determination of a range of technological parameters. Wetting and disintegregation time matched with the requirements of EP IV Ed., for almost all these formulations. Dissolution profiles suggested that the combined action of the hydrophobic lecithin and the coating delay the release of the drug from tablets with respect to when it is free or in the form of simple granules. By an appropriate combination of excipients it was thus possible to obtain orally disintegrating tablets and a delayed release of ibuprofen using simple and conventional techniques.
Fini
Adamo
A
Dipartimento SMETEC, University of Bologna, Bologna, Italy. adamo.fini@unibo.it <adamo.fini@unibo.it>
Bergamante
Valentina
V
Ceschel
Gian Carlo
GC
Ronchi
Celestino
C
de Moraes
Carlos Alberto Fonseca
CA
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000737:chemistry*; D001218:Aspartame / Q000008:administration & dosage; D002626:Chemistry, Pharmaceutical / Q000379:methods; D003692:Delayed-Action Preparations / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods*; D004355:Drug Stability; D007052:Ibuprofen / Q000008:administration & dosage* / Q000737:chemistry*; D011109:Polymethacrylic Acids / Q000737:chemistry; D011145:Polyvinyls / Q000737:chemistry; D011205:Povidone / Q000737:chemistry; D013213:Starch / Q000031:analogs & derivatives / Q000737:chemistry; D013607:Tablets; D013818:Thermogravimetry; D013997:Time Factors
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D011109:Polymethacrylic Acids; D011145:Polyvinyls; D013607:Tablets; C038300:methylmethacrylate-methacrylic acid copolymer; C013215:polyvinyl acetate; D013213:Starch; C050766:starch acetate; C048390:sodium starch glycolate; D011205:Povidone; D007052:Ibuprofen; D001218:Aspartame