Abstract
There is an increasing demand for more patient compliant dosage form and a novel method is the development of orally disintegrating tablets which dissolve or disintegrates instantly on the patient tongue or buccal mucosa. It is suited for tablets undergoing high first pass metabolism and is used for improving bioavailability with reducing dosing frequency to minimize side effect and make it more cost effective. Oral route having the highest patient compliance is regarded as the most convenient, safest and also the most economical method of drug delivery. Fast dissolving tablets are one such most advantageous example of the oral drug delivery. These tablets readily dissolve or disintegrate in the saliva i.e. within less than 60sec without the need for water. In the present study fast dissolving tablet of Salbutamol Sulphate was formulated, prepared and evaluated. The objective was to fabricate the fast dissolving tablet for rapid release of drug, their characterization, and in-vitro drug release studies. Salbutamol Sulphate being a water soluble drug would be readily available in a dissolved form for rapid oral uptake. The rapid dissolving concept in case of Salbutamol Sulphate could be of a great importance in reliving acute asthmatic shocks. The drug was analyzed by UV, IR and DSC studies. The drug sample was found to comply with all the specifications. The tablets were formulated by using different super disintegrants, in different ratio by various techniques like direct compression, sublimation and solid dispersion. The blends were evaluated for mass volume relationship, flow properties and for compressibility properties. The tablets were evaluated for various physicochemical characteristics like color, odor, thickness, diameter, visual inspection for any defects, weight variation, hardness, friability, disintegration time and wetting time. The tablets were also evaluated for uniformity of drugs content and in-vitro drug release. In conclusion, the tablets prepared by solid dispersion method with crospovidone as a superdisintegrant shows better release profile as compared to other techniques.
Highlights
Fast dissolving tablets (FDTs) are solid single-unit dosage forms that are placed in mouth, allowed to disperse/dissolve in the saliva without the need of water and provide a quick onset of action
US Food and Drug Administration Center for Drug Evaluation and Research (CDER) defines, in the ―Orange Book,‖ an ODT as ―a solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.‖ European Pharmacopoeia described ODTs as ―uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed‖ and as tablets which should disintegrate within 3 minutes [6]
Fast dissolving tablets were prepared by direct compression, sublimation and solid dispersion methods. 4 mg Salbutamol sulphate was taken in all the formulations
Summary
Fast dissolving tablets (FDTs) are solid single-unit dosage forms that are placed in mouth, allowed to disperse/dissolve in the saliva without the need of water and provide a quick onset of action. Some drugs are absorbed from mouth, pharynx and oesophagus as the saliva passes down into the stomach. In such cases, bioavailability of drug is significantly greater than those observed from conventional tablet dosage form. US Food and Drug Administration Center for Drug Evaluation and Research (CDER) defines, in the ―Orange Book,‖ an ODT as ―a solid dosage form containing medicinal substances, which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.‖ European Pharmacopoeia described ODTs as ―uncoated tablets intended to be placed in the mouth where they disperse rapidly before being swallowed‖ and as tablets which should disintegrate within 3 minutes [6]. The amount of drug that is subjected to first pass metabolism is reduced as compared to standard tablet [10]
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