The effect of atenolol tablet excipients on solid-state physical stability

Background and

Oral route is the most frequently used route for drug administration and tablets are the most popular oral drug forms. The study of drug-excepient compatibility is an important process in development of a stable solid dosage form. Incompatibility between drugs and excipients can alter the stability and bioavailability of drugs, thereby affecting its safety and/or efficacy. In this study, the effects of formulation ingredients under aging and environmental factors on physical properties of atenolol tablets were evaluated.

Atenolol tablets were obtained by the Direct Compression method and using different excepients. After conducting some initial tests, tablets were subjected indifferent temperatures and humilities for six months. From different formulations, the atenolol release and disintegration time were analyzed. Differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) were used to determine the possible interactions between drug and excipients.

The results of drug release from different formulations after 3 and 6 months storage in 25°C/60% relative humidity (RH) and 40°C/75%RH showed significant differences among various times. Under all the storage conditions, atenolol tablets showed an increase in disintegration time. DSC and FTIR did not show any interaction.

The results of dissolution and disintegration time showed that keeping atenolol tablets for three or six months in different conditions caused significant changes in the drug release and disintegration. Moreover, no change was observed in the physical stability of tablets.