Formulation and evaluation of diclofenac sodium dispersible tablets
type: CreativeWork
description: Diclofenac sodium is a non-steroidal, anti-inflammatory drug used for the relief of pain and inflammation. Many patients have difficulty swallowing tablets and consequently do not take medication as prescribed. To achieve optimum benefit of a drug, it is desirable to present it in a formulation which can rapidly disperse in water. This formulation is easier to swallow, therefore enhancing patient compliance. The aim of this study was to develop a stable diclofenac sodium dispersible tablet for easier oral administration. The first step in the product development was an investigative study into the physico-chemical properties, indications, side-effects and contra-indications of diclofenac sodium. Diclofenac sodium - excipient compatibility studies were performed as part of a preformulation study. Methods of evaluation included differential scanning calorimetry (DSC) and high performance liquid chromatography (HPLC). Four dispersible tablet formulations were developed. Kollidon CL-M (crospovidone) and Disolcel (croscarmellose sodium) were used as disintegrants in concentrations of 2% and 5% of the tablet mass. Tabletting was performed using a Cadmach® (India) single-punch tabletting machine. The four formulations were put on accelerated stability according to ICH guidelines for three months at 25°C/60%RH, 30°C/65%RH and 40°C/75%RH. HPLC was used to determine the identification, chromatographic purity and concentration of diclofenac sodium. Other tests included uniformity of mass, hardness, friability, disintegration, fineness of dispersion, loss on drying and dissolution. Thermal compatibility studies revealed potential interactions between diclofenac sodium and the excipients. Since DSC results only serve as a rough indication of possible interactions, accelerated stability testing using HPLC was used as a more selective method to identify potential interactions between diclofenac sodium and excipients. The HPLC results revealed that no interactions exist between dic…
abstract: Diclofenac sodium is a non-steroidal, anti-inflammatory drug used for the relief of pain and inflammation. Many patients have difficulty swallowing tablets and consequently do not take medication as prescribed. To achieve optimum benefit of a drug, it is desirable to present it in a formulation which can rapidly disperse in water. This formulation is easier to swallow, therefore enhancing patient compliance. The aim of this study was to develop a stable diclofenac sodium dispersible tablet for easier oral administration. The first step in the product development was an investigative study into the physico-chemical properties, indications, side-effects and contra-indications of diclofenac sodium. Diclofenac sodium - excipient compatibility studies were performed as part of a preformulation study. Methods of evaluation included differential scanning calorimetry (DSC) and high performance liquid chromatography (HPLC). Four dispersible tablet formulations were developed. Kollidon CL-M (crospovidone) and Disolcel (croscarmellose sodium) were used as disintegrants in concentrations of 2% and 5% of the tablet mass. Tabletting was performed using a Cadmach® (India) single-punch tabletting machine. The four formulations were put on accelerated stability according to ICH guidelines for three months at 25°C/60%RH, 30°C/65%RH and 40°C/75%RH. HPLC was used to determine the identification, chromatographic purity and concentration of diclofenac sodium. Other tests included uniformity of mass, hardness, friability, disintegration, fineness of dispersion, loss on drying and dissolution. Thermal compatibility studies revealed potential interactions between diclofenac sodium and the excipients. Since DSC results only serve as a rough indication of possible interactions, accelerated stability testing using HPLC was used as a more selective method to identify potential interactions between diclofenac sodium and excipients. The HPLC results revealed that no interactions exist between dic…
author: Van Vuuren, Carin Eloïse Jansen
date published: 2007
date modified: 2026-07-24T03:33:45Z
provider: North-West University (South Africa)
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: North-West University

PropertyValue
property ID: Handle
value: http://hdl.handle.net/10394/1053