Evaluation of drug-excipient interaction in the formulation of celecoxib tablets


Bozdag-Pehlivan S., Subasi B., VURAL İ., Unlu N., ÇAPAN Y.

Acta Poloniae Pharmaceutica - Drug Research, vol.68, no.3, pp.423-433, 2011 (Journal Indexed in SCI Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 68 Issue: 3
  • Publication Date: 2011
  • Title of Journal : Acta Poloniae Pharmaceutica - Drug Research
  • Page Numbers: pp.423-433
  • Keywords: Celecoxib, drug-excipient interaction, permeability, Caco-2 cells, EXTENDED-RELEASE FORMULATIONS, IN-VITRO, BETA-CYCLODEXTRIN, MATRIX TABLETS, COMPATIBILITY, CACO-2, CELL, PERMEABILITY, ABSORPTION, SYSTEMS

Abstract

In the present study, the possible interactions between celecoxib and some excipients (colloidal silicon dioxide (Aerosil®), microcrystalline cellulose (Avicel® PH 102), lactose anhydrous, magnesium stearate, cross-povidone and talc) were evaluated by examining the pure drug or drug-excipient powder mixtures which were stored under different conditions (25 ± 2°C, 60% RH ± 5% RH or 40 ± 2°C, 75% RH ± 5% RH) and different period (30 or 60 days) using DSC, FT-IR and HPLC. In order to investigate the possibility of celecoxib-excipient interaction in aqueous medium, dispersions of the pure drug or drug in physical powder mixture (1:1 w/w) in water (1%, w/v) were also prepared and evaluated by FT-IR and HPLC at day 0 and day 7 (40 ± 2°C). The interaction between celecoxib and magnesium stearate or colloidal silicon dioxide were determined in the aqueous dispersions by FT-IR. Different tablet formulations with or without excipients tested were prepared, and assessed for drug dissolution and permeability.