A pharmacokinetic and endoscopic comparison of an oral and an experimental buccal piroxicam formulation.
We compared the endoscopic effects and pharmacokinetic profiles of an experimental buccal formulation of piroxicam to oral capsules in an attempt to determine whether nonsteroidal antiinflammatory drug-induced gastropathy is due to a local or systemic effect. Ten healthy subjects received 20 mg piroxicam daily in a double-blind, randomized, crossover, placebo-controlled study. Upper endoscopies were performed at the baseline and at the end of each 2-week dosing arm of the study. Pharmacokinetic data obtained included serum and gastric piroxicam concentrations and serum 5'-hydroxypiroxicam metabolite concentrations after the first dose and 2 weeks of dosing. No differences in endoscopy scores or patient symptom scores were noted between the two dosage forms after 2 weeks of dosing. Pharmacokinetic data of piroxicam and the metabolite revealed that the buccal formulation may not have been absorbed exclusively from the buccal mucosa.
Mueller
B A
BA
Department of Pharmacy Practice, School of Pharmacy, Purdue University, West Lafayette, Indiana.
Rex
D K
DK
Figueroa
N
N
Greene
P
P
Brater
D C
DC
D000278:Administration, Buccal; D000284:Administration, Oral; D000328:Adult; D002626:Chemistry, Pharmaceutical; D004311:Double-Blind Method; D005260:Female; D005750:Gastric Juice / Q000737:chemistry; D005773:Gastroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009055:Mouth / Q000737:chemistry; D010894:Piroxicam / Q000009:adverse effects* / Q000031:analogs & derivatives / Q000032:analysis / Q000097:blood / Q000493:pharmacokinetics*; D013272:Stomach Diseases / Q000139:chemically induced* / Q000473:pathology
D010894:Piroxicam; C051024:5'-hydroxypiroxicam