LOCAL TISSUE TOLERABILITY OF MELOXICAM, A NEW NSAID - INDICATIONS FORPARENTERAL, DERMAL AND MUCOSAL ADMINISTRATION

Meloxicam is a new non-steroidal anti-inflammatory drug (NSAID) which has potent anti-arthritic activity and a reduced potential to induce g astric irritation in animals. The present series of animal studies inv estigated the local and/or systemic tolerance of meloxicam formulation s: intravenous, intramuscular and subcutaneous injections, eye-drops, gel and suppositories. The concentration and formulations were as inte nded for therapeutic use in man. An in vitro haemolysis lest demonstra ted that the parenteral formulation of meloxicam produced only minimal haemolysis. In comparison, NSAIDs such as piroxicam, ketoprofen and i ndomethacin showed comparable haemolysis only after dilution. Diclofen ac and ibuprofen caused considerable haemolysis even when diluted. In all studies, the local tolerance of meloxicam was good and did not dif fer from placebo, even when administered daily for 4 weeks. Few abnorm al histopathological findings indicative of organ toxicity were observ ed. There were only small, transient macroscopic changes at the site o f administration, with no striking histopathological changes directly attributable to meloxicam. Intramuscular piroxicam and diclofenac, how ever, resulted in development of an extensive, solitary necrotic area. Other formulations tested were also very well tolerated. In conclusio n, all meloxicam formulations tested exhibited excellent tissue tolera bility. Therefore, meloxicam appears to be suitable for parenteral, de rmal and mucosal administration.