Evaluation Of Pregelatinized Enset (ensete Ventricosum) Starch As A Tablet Disintegrant In Enteric Coated Acetyl Salicylic Acid Tablet

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The process of aqueous coating of moisture labile drugs demands careful selection ofrntablet excipients, mainly disintegrants. Although the application of pregelatinized ensetrnstarch (PGES) as tablet disintegrant is well documented, its potential use as tabletrndisintegrant in the development of moisture labile drug for aqueous coating is not wellrnstudied. Therefore, the objective of this study is to assess its potential use as tabletrndisintegrant in the development of enteric coated acetylsalicylic acid (ASA) 81 mg tabletrnin comparison to other starch based disintegrants including native enset starch (ES),rnsodium starch glycolate (SSG) and pregelatinized starch 1500® (PGS 1500). ASA is arnmoisture-sensitive drug and can be hydrolyzed into acetic and salicylic acid whenrnexposed to high humidity and elevated temperature. As the coating process will subjectrnASA tablets to both high temperature and humidity, it is important that the formulationrnexhibit minimum interaction with the aqueous coating solution.rnThe study began with the development of an optimum coating technique, which canrnoffer the maximum mechanical and chemical stability and other pertinent tablet qualitiesrnbut minimum exposure time to the coating solution to the tablet. Then, to investigate therneffect of the type and quantity of the disintegrant on stability and other tablet attributes,rntwelve different ASA 81 mg tablet formulations, containing three different levels of thernabove four disintegrants, were directly compressed using microcrystalline cellulosern(MCC) as a direct compression filler and talc as a lubricant and characterized. Therntablets were then coated using enteric coating polymer Wangit L30D-55 (aqueousrndispersion of methacrylic acid-ethyl acrylate copolymers) by conventional pan coatingrntechnique and were further characterized. Finally, the tablets were subjected to a threernmonth accelerated stability study conditions and the stability of the tablets was assessedrnbased on coat integrity, assay results and change in the level of free salicylic acid withinrnthe formulation.rnThe results of the study showed that the uncoated tablets had the desired attributesrnincluding tablet weight variation, friability, hardness, disintegration time and dissolutionrntime results which were well within the acceptable limits of the USP 30-NF 25 (2007)rnixrnstandards. Results of the three month accelerated stability study showed that tabletsrnformulated with sodium starch glycolate were unstable and resulted in softening andrnsticking of the coat. Besides, there was a significant increase in free salicylic acidrnpercentage and release of drug in the acidic stage. Unlike tablets formulated with sodiumrnstarch glycolate, tablets formulated with the pregelatinized starches, pregelatinized ensetrnstarch and starch 1500® as disintegrants maintained their appearance and the cumulativernpercent drug release in 0.1 N HCl and buffer stage. Percent free salicylic acid, assayrnresults and other tablet attributes unchanged except tablet hardness, which was alsornwithin the acceptable limit. Tablets prepared with ES were stable but ES was inferior asrntablet disintegrant. Therefore, pregelatinized enset starch can be used as a betterrnalternative to sodium starch glycolate and as a replacement to pregelatinized starchrn1500® as tablet disintegrant in those formulation that contain moisture susceptible drugs.rnKey Words: Enset starch; Disintegrant; Stability; Enteric coated; Acetylsalicylic Acid;rnPregelatinized starch, Sodium starch glycolate

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Evaluation Of Pregelatinized Enset (ensete Ventricosum) Starch As A Tablet Disintegrant In Enteric Coated Acetyl Salicylic Acid Tablet

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