Comparative Study of Natural & Synthetic Super Disintegrants in Development of Cost-Effective Oro-Dispersible Tablets of Amlodipine Besylate

Abstract

Background: Fast dissolving tablets or orodispersible tablets dissolve or break down as soon as the patients place it on the tongue or buccal mucosa. This is appropriate drug delivery system where drugs are subject to high first pass metabolism. It enhances bioavailability, decreases the dosing frequency and thus reduces the side effects and also makes the dosage form cost effective. This paper examined polysaccharide extracted in the seeds of Cassia tora as a super disintegrant in the or dispersible tablets. The antihypertensive drug that was selected as a model drug was amlodipine besylate.

Methods: The direct compression method was used to prepare amlodipine besylate tablets with different concentrations (1, 2.5, 5 and 7.5 percent w/w) of isolated C. Tora seed polysaccharide (natural) and sodium starch glycolate (synthetic) as a super disintegrant. Evaluation of tablets was done for various pre- and post-compression parameters. The stability tests were done on optimized formulation F4. The in-vitro release of the drug and disintegration time of the formulation F4 was compared to marketed formulations (conventional tablets).

Results: Fourier transform infrared studies were done to characterize the drug excipient interactions. Formulation F4 with 7.5% polysaccharide exhibited good wetting time, disintegration time in comparison to a formulation made with a synthetic super disintegrant at the same concentration level. Therefore, the batch F4 was optimized formulation.

Conclusion: The current study has shown that C. Tora seed polysaccharide could be a good disintegrant when used in the preparation of or dispersible tablets. Since C. Tora polysaccharide is cheap compared to synthetic super disintegrants, nontoxic, compatible and simple to produce, it can be utilized to replace the existing marketed super disintegrants.