Document

Quality of Amoxicillin and Clavulanic acid Tablets in Thailand
  • 4.12.2017
  • 18,350
Quality of Amoxicillin and Clavulanic acid Tablets in Thailand
Owner / Producer Owner / Producer
Sumana Sirisoonthorn, Witinee Kongsuk, Gobboon Boonyen, Sasida Yoosook, Yaowalak Wattanapisit
Year Year
2016
Pages Pages
16
Details

Amoxicillin and Clavulanic acid combination is the well-known dosage form of antibiotics. It was developed to improve the efficiency and optimize the effects. The crucial problem of this dosage form is its stability due to the tendency to degrade. To assure the quality of the products, the amoxicillin and clavulanic acid tablets have been chosen to study under the project “Quality Assurance of Medicines under the Universal Health Care Coverage” by Bureau of Drug and Narcotic, Department of Medical Sciences. The pharmaceutical testing was performed and evaluated using the verified method and in compliance with the USP 34 monograph. The total number of samples was 131. The samples came from 42 drug dossiers which were from four Thai local manufacturers and fifteen international ones. The samples were tested on the following topics: assay, weight variation, content uniformity, dissolution, and water determination. The results showed that 122 samples (93%) passed and 9 samples (7%) failed to meet the quality standards. The failed samples were one for the assay of clavulanic acid, two for the content uniformity of clavulanic acid, one for both the assay and content uniformity of clavulanic acid, and five for dissolution testing. The study revealed that the quality problems of Amoxicillin and Clavulanic acid Tablets still exist. Hence, the manufacturing process, the quality of ingredients, as well as the packaging and storage procedures play the important role in the quality of products.

https://he02.tci-thaijo.org/index.php/dmsc/article/view/241702