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      Development and evaluation of orodispersible tablets using a natural polysaccharide isolated from Cassia tora seeds

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          Abstract

          Background

          Orodispersible tablets or fast dissolving tablets dissolve or disintegrate immediately on the patients’ tongue or buccal mucosa. This drug delivery system is suitable for drugs undergoing high first pass metabolism. It improves bioavailability, reduces dosing frequency, and thereby minimizes the side effects and also makes the dosage form more cost-effective. In this study, polysaccharide isolated from the seeds of Cassia tora was investigated as a superdisintegrant in the orodispersible tablets. The model drug chosen was valsartan, an antihypertensive drug.

          Methods

          Valsartan tablets were prepared separately using different concentrations (1%, 2.5%, 5%, and 7.5% w/w) of isolated C. tora seed polysaccharide (natural) and sodium starch glycolate (synthetic) as superdisintegrant by the direct compression method. Evaluation of tablets was done for various pre- and postcompression parameters. The stability studies were performed on optimized formulation F4. The disintegration time and in vitro drug release of the formulation F4 were compared with marketed formulations (conventional tablets).

          Results

          The drug excipient interactions were characterized by Fourier transform infrared studies. The formulation F4 containing 7.5% polysaccharide showed good wetting time and disintegration time as compared to a formulation prepared using a synthetic superdisintegrant at the same concentration level. Hence, batch F4 was considered optimized formulation.

          Conclusion

          The present work revealed that C. tora seed polysaccharide has a good potential as a disintegrant in the formulation of orodispersible tablets. Because C. tora polysaccharide is inexpensive as compared to synthetic superdisintegrants, nontoxic, compatible, and easy to manufacture, it can be used in place of currently marketed superdisintegrants.

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          Most cited references35

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          Tagatose, the new GRAS sweetener and health product.

          V. Levin (2001)
          Tagatose, a low-calorie, full-bulk natural sugar, has just attained GRAS (Generally Recognized As Safe) status under U.S. Food and Drug Administration (FDA) regulations, thereby permitting its use as a sweetener in foods and beverages. This paper presents all current aspects of tagatose with respect to demonstrated food and beverage applications and the potential health and medical benefits of this unique substance. Summarized studies are referenced to detailed peer-reviewed papers. The safety studies followed the recommendations in the FDA "Red Book." Results were submitted to an Expert Panel for determination of GRAS status under FDA regulation. Small phase 2 clinical trials showed tagatose to be effective in treating type 2 diabetes. The results, buttressed by the references cited, support the efficacy of the various applications disclosed for tagatose. Tagatose has been found to be safe and efficacious for use as a low-calorie, full-bulk sweetener in a wide variety of foods, beverages, health foods, and dietary supplements. It fills broad, heretofore unmet needs for a low-calorie sweetener in products in which the bulk of sugar is important, such as chocolates, chewing gum, cakes, ice cream, and frosted cereals. Its synergism with high-intensity sweeteners also makes it useful in sodas. Various health and medical benefits are indicated, including the treatment of type 2 diabetes, hyperglycemia, anemia, and hemophilia and the improvement of fetal development.
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            Practical Pharmacognosy Techniques and Experiments

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              Development of Fast Dispersible Aceclofenac Tablets: Effect of Functionality of Superdisintegrants

              Aceclofenac, a non-steroidal antiinflammatory drug, is used for posttraumatic pain and rheumatoid arthritis. Aceclofenac fast-dispersible tablets have been prepared by direct compression method. Effect of superdisintegrants (such as, croscarmellose sodium, sodium starch glycolate and crospovidone) on wetting time, disintegration time, drug content, in vitro release and stability parameters has been studied. Disintegration time and dissolution parameters (t50% and t80%) decreased with increase in the level of croscarmellose sodium. Where as, disintegration time and dissolution parameters increased with increase in the level of sodium starch glycolate in tablets. However, the disintegration time values did not reflect in the dissolution parameter values of crospovidone tablets and release was dependent on the aggregate size in the dissolution medium. Stability studies indicated that tablets containing superdisintegrants were sensitive to high humidity conditions. It is concluded that fast-dispersible aceclofenac tablets could be prepared by direct compression using superdisintegrants.
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                Author and article information

                Contributors
                Journal
                Integr Med Res
                Integr Med Res
                Integrative Medicine Research
                Elsevier
                2213-4220
                2213-4239
                18 March 2014
                June 2014
                18 March 2014
                : 3
                : 2
                : 91-98
                Affiliations
                [0005]Department of Quality Assurance, Dr. L.H. Hiranandani College of Pharmacy, Ulhasnagar, Maharashtra, India
                Author notes
                [* ] Corresponding author. Department of Quality Assurance, Dr. L. H. Hiranandani College of Pharmacy, Smt. CHM Campus, Opp. Railway Station, Ulhasnagar 421003, Maharashtra, India harshal.dlhhcop@ 123456gmail.com
                Article
                S2213-4220(14)00022-5
                10.1016/j.imr.2014.03.002
                5481693
                3da18b1f-5ba7-46f0-924d-804e36d65fa5
                © 2014 Korea Institute of Oriental Medicine. Published by Elsevier.

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 13 January 2014
                : 10 March 2014
                : 10 March 2014
                Categories
                Original Article

                cassia tora,direct compression,orodispersible tablets,patient compliance,sodium starch glycolate

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