Category: Professional Posters
Purpose: Amlodipine besylate, the active ingredient of Amlor® capsule, is a dihydropyridine Calcium Channel Blocker. After the expiration of the patency in 2007, many generics have been released into the market. While generic drugs and the innovator contains the same labeled active materials, they may not be identical due to differences in excipients, source of raw materials, and manufacturing process. These differences may affect the efficacy and safety of drugs. Consequently, the aim of the current study is to compare five generic formulations of amlodipine besylate 5mg to the brand formulation Amlor® 5mg
Methods: In-vitro dissolution tests were done on the brand and generic formula using Erweka dissolution apparatus. Assay and uniformity of content were done on the drugs using UV Spectrophotometry. Absorbance was measured at λmax 363 nm and the % recovery of amlodipine besylate was calculated for the different brands and compared with that of the innovator.
Results: With respect to the assay data, the innovator content was 101.77 % of the claimed amount, while one generic hadn’t passed the acceptance criteria (± 5%). Uniformity of content of the innovator had an average content of 102.44%, and all tested generics comply with the acceptance criteria. The results obtained for the disintegration test of different generics were compared to those of the innovator using one-way ANOVA Test, and all tested generic showed a significant difference (p<0.05), though they all comply with the acceptance criteria. As for the dissolution test, all tested capsules had more than 90% release within 30 minutes and thus complying with the specified criteria.
Conclusion: In conclusion, the innovator together with four out of the five generics showed compliance with the specifications required while only one was not complying. Accordingly, those four could be used safely as an alternative to Amlor® with the advantage of lower costs.