Lornoxicam is a NSAID of the oxicam class and it has the same side effects of this group
when taken orally. In attempts to avoid the systemic side effects of lornoxicam (e.g. gastric
irritation) and to achieve sustained release of the drug, several buccal patch formulations
containing lornoxicam were prepared using different polymers and were evaluated for in-vitro
characteristics in part I of this study. In the current study, the selected formulations (based on
the previous in-vitro data) are evaluated for in-vivo performance using experimental animals
and clinical efficacy on human volunteers. Pharmacokinetic parameters were assessed
following application of the selected patches in rabbits. A comparative clinical study was
conducted on patients with post-operative pain and edema following maxillofacial operations.
The results of the in-vivo animal experiment showed that lornoxicam formulated in different
buccal patches was successfully delivered to the systemic circulation and showed high absolute
bioavailability of lornoxicam. The clinical study results revealed that sodium carboxy methyl
cellulose (NaCMC, 3%) formulation applied to the buccal mucosa was slightly better or equally
effective to the orally administered commercial oxicam product (Feldene Flash® tablets) in
reducing pain level, swelling and tenderness within a period of 4 days with no observed side
effects. These findings suggest that lornoxicam administered in this buccal patch may present a
potential therapeutic use as a strong anti-inflammatory and analgesic agent.