J Korean Rheum Assoc.  1994 Jul;1(2):232-238.

The Pharmacokinetic Study Of Fi-Cyclodextrin-Piroxicam And Its Efficacy In The Treatment Of Osteoarthritis

• Lee SH
• Min DJ
• Park SH
• Cho CS
• Park DJ
• Kim HY

Abstract

OBJECTIVES
To evaluate the efficacy, safety and pharmacokinetics of fi-cyclodextrin-piroxicam in patients with osteoarthritis of knee.
METHODS
Thirty patients with osteoarthritis(28 women, 2 men) were enrolled in the study. fi-cyclodextrin-piroxicam 20mg was administered orally, once daily for 8 weeks. The indices of efficacy(evaluation of the pain, joint swelling, tenderness and functional limitation) were evaluated at 0,2,4,8 weeks. Piroxicam plasma concentrations were determined by HPLC over 24 hours in 4 healthy volunteers, and were compared with those of reference formulation.
RESULTS
There were statistically significant improvement in the indices of efficacy between entry and end of the study. The majority of side effects were related to the gastrointestinal tract, but the symptoms were mild except 1 drop-out case. According to pharmacokinetic study, the bioavailability and absorption rate of piroxicam were improved in fi-cyclodextrin-piroxicam group. Peak plasma piroxicam concentrations were higher in fi-cyclodextrin-piroxicam group than were in reference group.
CONCLUSIONS
fi-cyclodextrin-piroxicam is efficacious and well tolerated in patients with osteoarthritis. Because of its rapid absorption, good bioavailability and fewer gastrointestinal disturbance, it seems to be a useful drug for long-term management of osteoarthritis.

Keyword

bata-cyclodextrin-piroxicam; osteoarthritis; pharmacokinetics

MeSH Terms

Absorption
Arthralgia
Biological Availability
Chromatography, High Pressure Liquid
Female
Gastrointestinal Tract
Healthy Volunteers
Humans
Osteoarthritis*
Osteoarthritis, Knee
Pharmacokinetics
Piroxicam
Plasma
Piroxicam