TY - JOUR AU - GABER, DALIA AU - ABDOUN, SIHAM AU - MASWADEH, HAMZAH AU - ALNASSR, EBTIHAL AU - AL-SALAMAH, MARAM PY - 2020/03/07 Y2 - 2024/03/28 TI - EQUIVALENCE STUDY OF IMMEDIATE RELEASE TABLETS OF BETA BLOCKER DRUG JF - International Journal of Applied Pharmaceutics JA - Int J App Pharm VL - 12 IS - 2 SE - Original Article(s) DO - 10.22159/ijap.2020v12i2.36477 UR - https://journals.innovareacademics.in/index.php/ijap/article/view/36477 SP - 53-59 AB - <p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Objective: </span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">The therapeutic equivalence of generic brands is a great challenge for manufacturers. This study aimed to evaluate the bioequivalence of four different generic brands of atenolol tablets under biowaiver conditions.</span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Methods: </span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Physiochemical properties of the tablet products namely uniformity of weight, hardness, disintegration, and drug content were assessed. The dissolution profiles of atenolol tablets were conducted in pH 1.2, 4.5, 6.8 and 7.6 buffers using USP dissolution apparatus II. Similarity and difference factors were calculated. Finally, four kinetic models have been offered to describe the release characteristics of atenolol under experiment conditions.</span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Results: </span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">All tablets showed accepted physiochemical characters. Dissolution profiles revealed that G2 showed the highest similarity to innovator (f2 91.86) in pH 7.6. Dissolution kinetics of G2 at the same pH could be best described as Higuchi model of release.&nbsp;</span></p><p style="text-align: justify; margin: 6.0pt 0in 6.0pt 0in;"><strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">Conclusion: </span></strong><span style="font-size: 8.0pt; font-family: 'Cambria','serif';">The study showed that excipients and manufacturing practices play an important role in marketing biowaiver generic products meet the international regulatory bodies criteria.</span></p> ER -