PRESS-COATED TABLETS FOR THE SEQUENTIAL PULSED ADMINISTRATION OF 2 DIFFERENT DRUGS

The most common risk connected with non-steroidal anti-inflammatory drugs (NSAIDs) oral administration is represented by their local irritation effects on the mucosa of the gastro-intestinal tract. To prevent NSAID-induced mucosal lesions and ulcer formation or exacerbation a new dosage form was designed for the administration in sequential pulses of a mucosal protective agent firstly and then NSAID. The active substances are formulated in a press-coated tablet in which the inner core contains sodium diclofenac and the outer shell sucralfate. The shell composition includes rapidly disintegrating agents for the prompt release of the mucosal protective agent. Diclofenac release from the core starts only when the outer layer has completely disintegrated. In vitro release of the anti-inflammatory drug is not influenced by the sucralfate delivery impulse. Preliminary in vivo studies confirm that the presence of sucralfate does not prevent diclofenac absorption from the GI tract.