Formulation Development of Directly Compressed Orally Disintegrating Tablets: Role of Disintegrants - Term Paper Example

To overcome the limitations from users’ reluctance to use traditional tablets, the consequences of which are non-compliance and ineffective therapy, pharmaceutical manufacturers try to improve oral drug delivery systems by developing oral disintegrating tablets (ODTs). To achieve the intended therapeutic action, a specific amount of drug should be released within a few seconds. Furthermore, most patients will have a better experience taking the medicine when the drug disintegrates quickly to avoid any disagreeable taste sensation.

On the other hand, decreasing the disintegration time requires using porous materials with a low compression force during production, which would lead to fragile tablets that are not suitable for packaging and transporting. Therefore, the choice of disintegrant has a significant impact on the formulation of ODTs in order to enhance the drug’s bioavailability and maintain the required balance between mechanical strength and disintegration time. This was done by comparing four types of disintegrants: crospovidone (CRP), sodium starch glycolate (SSG), croscarmellose sodium (CCS), and corn starch (CS), in three different concentrations for each disintegrant 2%, 5%, and 8%, which were formulated in twelve batches.

The remaining excipients; mannitol, magnesium stearate, and microcrystalline cellulose were added to all batches. Furthermore, one batch was prepared as a control without any disintegrants. 15 tablets from each batch were prepared using the direct compression method. Moisture content, flowability, general appearance, uniformity of thickness and diameter, weight variation, hardness, porosity, friability, and disintegration time tests were carried out on each batch, and the results underwent statistical analysis (ANOVA).

The results obtained from this project conclude that there were no (shows) there are no significant differences in Angle of repose (flowability), moisture content test, and porosity tests between the 12 batches.