Multi-dimensional Comparative Study on Quanlity of Azithromycin Dry Suspension from Different Manufacturers

Hongyan Fan; Jiaoqin Xue; Pengfei Cui

doi:10.6911/WSRJ.202511_11(11).0008

Authors

Hongyan Fan
Jiaoqin Xue
Pengfei Cui

DOI:

https://doi.org/10.6911/WSRJ.202511_11(11).0008

Abstract

Objective: To compare the quality of azithromycin dry suspensions from different manufacturers. Methods: A comparative study was conducted on azithromycin dry suspensions produced by the original research manufacturer and two enterprises from China. The quality of each preparation was compared and evaluated by determining data such as appearance, content, palatability, redispersibility, and dissolution profile of azithromycin dry suspensions from different manufacturers. Results: The azithromycin content of products from all manufacturers ranged from 90% to 110%, meeting the requirements of the Chinese Pharmacopoeia. There were differences to varying degrees in indicators including appearance, palatability, and redispersibility. The dissolution profiles were similar in the pH 6.8 medium. In the pH 7.2 medium, the dissolution behavior of azithromycin dry suspension (Manufacturer W) was similar to that of the original research preparation, while the dissolution rate of azithromycin dry suspension (Manufacturer P) was excessively fast. Conclusion: The azithromycin content of the dry suspensions from the three manufacturers all meets the requirements of the Chinese Pharmacopoeia; however, there are differences in indicators such as appearance, palatability, redispersibility, and dissolution profile in the pH 7.2 medium.

Downloads

Download data is not yet available.

References

[1] Wei Lizhi, Li Fajuan, He Nai'ao. Research Progress on the Mechanism of Action, Drug Resistance Mechanism and Application of Macrolide Antibiotics [J]. Journal of Rational Drug Use, 2019, 12(15): 175-178.

[2] Wang Chengcheng, He Zheng, Feng Maoyan, et al. A Case of Azithromycin-related Extrapyramidal Reactions and Literature Analysis [J]. Chinese Journal of New Drugs and Clinical Remedies, 2021, 40(04): 318-320.

[3] Shi Hongjuan, Ouyang Xu, Wang Ruiqiang, et al. Preparation and In Vivo and In Vitro Evaluation of Azithromycin for Suspension [J]. Chinese Journal of Pharmaceuticals, 2023, 54(08): 1216-1223. DOI: 10.16522/j.cnki.cjph.2023.08.011.

[4] Wu Yifan, Liu Fuli, Wang Yamin. Pharmaceutical Concerns in the R&D and Evaluation of Oral Solutions for Children [J]. Chinese Journal of Pharmaceuticals, 2022, 53(11): 1579-1582.

[5] Roderlck J. Ray, Leah Appel, Dwayne Friesen, et, al, Controlled released dosage forms of azithromycin: USA, 2005123615 [P]. 2005-6-9

[6] Wang, H., & Zhang, X. W. (2024, August 29). Development of liquisolid technology to overcome dissolution/absorption limitations of oral drugs. Pharmaceut Fronts, 6, e265–e275

[7] National Medical Products Administration, National MedicalProducts Administration - datasearch [DB/OL]. Beijing: NationalMedical Products Administration, 2023 (2023-06-21).

[8] Qi Shuye, Zheng Yi, Huang Min, et al. Comparison and Improvement of Palatability of Azithromycin for Suspension [J]. Acta Pharmaceutica Sinica, 2023, 58(11): 3216-3221.

[9] Jia Wenjun, Tong Liqing. Comparison of Dissolution Rates of Azithromycin for Suspension from Different Manufacturers [J]. Chinese Journal of Drug Evaluation, 2017, 34(4): 258-260.