Lornoxicam Immediate-Release Tablets: Formulation and Bioequivalence Study in Healthy Mediterranean Volunteers Using a Validated LC-MS/MS Method.
This study aimed to demonstrate interchangeability between 2 lornoxicam tablet formulations under fasting conditions among Mediterranean Arabs by using a newly validated high-pressure liquid chromatography-tandem mass spectrometry method. A single-oral solid dosage form (8 mg/tablet), randomized, open-label, 2-way crossover study was conducted on 30 healthy male volunteers. Blood samples were collected prior to dosing and over a 24-hour period, and the washout period was 9 days. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between generic and branded products. The point estimates (ratios of geometric mean %) were 90.91, 96.34, and 94.86 for Cmax,AUC0-last, and AUC0-∞, respectively. The 90% confidence intervals were within the predefined limits of 80.00%-125.00%, as specified by the international guidelines. This study showed that both formulations met the regulatory criteria for bioequivalence.
Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National University, Nablus, Palestine.
Abdel Naser
AN
Zaid
R&D Department, Avalon Pharma (Middle East Pharmaceutical Industries Co. Ltd.), Riyadh, Kingdom of Saudi Arabia.
Ayman
A
Mousa
Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National University, Nablus, Palestine.
Nidal
N
Jaradat
Pharmaceutical Research Unit, Amman, Jordan.
Rana
R
Bustami
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000493:pharmacokinetics; D018912:Arabs; D019540:Area Under Curve; D002853:Chromatography, Liquid / Q000379:methods; D018592:Cross-Over Studies; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D019083:Mediterranean Region; D008875:Middle Aged; D010894:Piroxicam / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D013607:Tablets; D053719:Tandem Mass Spectrometry / Q000379:methods; D013810:Therapeutic Equivalency; D055815:Young Adult
D000894:Anti-Inflammatory Agents, Non-Steroidal; D016568:Drugs, Generic; D013607:Tablets; D010894:Piroxicam; C059451:lornoxicam
HPLC-MS/MS; QbD; bioequivalence; lornoxicam