IN-VITRO COMPARATIVE QUALITY ASSESSMENT OF DIFFERENT BRANDS OF DICLOFENAC SUPPOSITORIES AVAILABLE IN THE KUMASI METROPOLIS, GHANAAbstract
Drugs play a vital role in maintaining and promoting health. The safety, efficacy, and quality of the drugs must be assessed to protect the health of the user. Diclofenac is a cyclooxygenase inhibitor and one of the most useful, effective commercially available NSAIDs used in the management of pain. Many different brands and dosage forms (tablets, oral powder, and suppositories) of diclofenac are available on the market. This study sought to determine the quality as well as the physicochemical equivalence of 10 diclofenac suppositories brands. The sampled suppository brands had their registration status verified from the FDA. They were subjected to in-vitro tests associated with the quality of suppository dosage form, and the tests were conducted according to the United States Pharmacopeia and British Pharmacopeia standards. Two of the brands had an expired registration, whiles two (2) also had not been registered. All except two of the brands complied with the USP for uniformity of weight; they all passed the disintegration test. The FTIR identification test proved the presence of diclofenac in all the brands. The percentage content of diclofenac in the various brands ranged from 99.3 to 115.7%, 6 of the brands had active contents above the acceptable criteria (95-105.0%), whiles 4 were within this stipulated range. Five brands failed the percentage release (70% of their contents within 45 min) test. The physicochemical evaluation showed that not all the diclofenac brands met the quality specification with respect to uniformity of weight, hardness, disintegration, and content assay.
Y. A. Osei *, A. Mintah, M. E. Boakye-Gyasi, R. Johnson and S. L. Kipo
Department of Pharmaceutics, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.
04 December 2020
25 June 2021
19 July 2021
01 November 2021