Evaluation of Celecoxib-Lactose Incompatibility Reactions at Solid State using Physicochemical Methods

 Drug excipient incompatibility evaluation is an important part of pre-formulation studies. Drug-excipient interaction may affect drug stability, bioavailability, therapeutic effects, efficacy, and safety. Therefore, development of a successful drug delivery systems or dosage forms depends on correct selection of excipients. The aim of this study is to evaluate of celecoxib-lactose incompatibility reactions at solid state using physicochemical methods.

Celecoxib and lactose were blended in 1:1 mass ratios and added to 20% (v/w) water and stored in closed vials at 60°C (inside the oven). Also, pure drug and pure excipient were prepared. Celecoxib, celecoxib-lactose and lactose tablets prepared using direct compression method. Produced tablets were stored at 60 °C (inside the oven). Finally, celecoxib -lactose incompatibility in the solid state was investigated by Fourier transform infrared (FTIR) and differential scanning calorimetry (DSC) methods over four consecutive weeks.

the incompatibility of celecoxib with lactose was not observed using physicochemical methods including DSC, FTIR spectroscopy and also visual observation.

It can be concluded that using lactose in celecoxib solid pharmaceutical preparations will not cause incompatibilities.