Project Report

On

Comparative Study on Nine Market Preparations of Diclofenac sodium Tablet

Available in Bangladesh

Department of Pharmacy
Southeast University

(A dissertation submitted to the Department of Pharmacy)

It has being submitted for partial fulfillment of the requirements for the degree of
B. Pharm (Honors) in Southeast University, Banani, Dhaka, Bangladesh.

Submitted by
ID: 2015000300090
Semester: Spring 2018

Southeast University
Banani, Dhaka-1213
 Abstract
Background: The aim of this work was to compare the dissolution behaviour of nine diclofenac
sodium prolonged release tablets of different brands obtained from the Bangladesh market. The
formulations contain the same amount of drug substance but different types and/or amount of
excipients. Diclofenac Sodium is a potent Non-Steroidal Anti-Inflammatory Drug (NSAID) and
that are widely used and it is an Over the Counter (OTC) drug in Bangladesh. Potency
determination was performed to evaluate that the marketed sample comply with the declared
specification or not.

Study design: Total nine different brands (Diclofen, A-Fenac, Ultrafen, Mobifen, Genac, Bt-
Fenac, Clofenac, Diclofenac, Diclofenac-50) of diclofenac sodium tablets from different
manufacturers were selected in the study.
Place & duration of study: The cross sectional study was conducted in Southeast University
Lab, Dhaka, Bangladesh from October 2018 to December 2018.

Materials and Method: Diclofenac Sodium is a type of non-drug which is established to treat
different symptoms by lessens the substances in the body that cause the pain and swelling to
occur. Total ten different brands of Diclofenac tablets from different manufacturers were
selected in the study. Dissolution testing was conducted according to USP from each brand for
25 minutes by using dissolution testing apparatus USP type-I (Basket). The tablets were
subjected to various post-production tests such as hardness, physical parameters like weight
variation, chemical parameters like assay, disintegration also considered for this study. Assay
and Dissolution was checked by using a UV Spectrophotometer where Phosphate Buffer was
used as dissolution medium.

Result and Discussions: The disintegration, hardness and weight variation test of Tablets were
performed as mentioned in BP or USP in world class equipment. All the results of these tests
were matched USP standards. If the disintegration time, hardness, weight variation of Tablets
varies a lot from the standard time, the tablets will not be able to show the desired therapeutic
effect on time in the patients, which in result will increase the risk of patients.

Conclusions: From the analysis of the results, this was observed that there was a considerable
variation in the dissolution rates and also in the pattern of hardness, assay, friability,
disintegration and weight of tablets.