The Quality of Dicloxacillin Sodium Capsules in Thailand

Abstract

       Dicloxacillin sodium belongs to the penicillin-group antibacterial drugs in the National List of Essential Medicines. In the fiscal year 2010, a study on pharmaceutical quality of dicloxacillin sodium capsules was conducted as a part of the project “Quality Assurance of Medicines under the Universal Health Care Coverage Scheme”. A total of 51 samples were collected from public hospitals nationwide and it was found that only 33 samples (64.7%) complied with the pharmacopeial specification whereas 18 samples (35.3%) did not. In the fiscal year 2012, pharmaceutical quality of dicloxacillin sodium capsules was re-evaluated. Bureau of Drug and Narcotic randomly collected 44 samples from public hospitals, while 50 samples were directly collected from local manufacturers by Thai Food and Drug Administration. A total of 94 samples consisted of 57 samples of 250-mg capsules and 37 samples of 500-mg capsules manufactured by 26 manufacturers with 48 registration numbers. The samples were evaluated according to the United States Pharmacopeia specification (USP 34) for assay, weight variation, water and dissolution. The method was verified prior to sample testing. The results showed that 88 samples (93.6%) complied with pharmacopeial specification. Six samples failed to comply with the quality standard with respect to content of active ingredient, weight variation and water. All samples tested met the requirements of the USP for dissolution. It can be concluded that most of dicloxacillin sodium capsules available in Thailand have satisfactory pharmaceutical characteristics.