Tsega, Bewket Beyene (2015) Evaluation of Pregelatinized Enset (Ensete ventricosum) Starch as a Tablet Disintegrant in Enteric Coated Acetyl Salicylic Acid Tablet. Masters thesis, Addis Ababa University.
![[img]](http://thesisbank.jhia.ac.ke/style/images/fileicons/application_pdf.png) |
PDF (Evaluation of Pregelatinized Enset (Ensete ventricosum) Starch as a Tablet Disintegrant in Enteric Coated Acetyl Salicylic Acid Tablet)
bewket Beyene.pdf - Accepted Version Restricted to Repository staff only Download (477kB) | Request a copy |
Abstract
The process of aqueous coating of moisture labile drugs demands careful selection of tablet excipients, mainly disintegrants. Although the application of pregelatinized enset starch (PGES) as tablet disintegrant is well documented, its potential use as tablet disintegrant in the development of moisture labile drug for aqueous coating is not well studied. Therefore, the objective of this study is to assess its potential use as tablet disintegrant in the development of enteric coated acetylsalicylic acid (ASA) 81 mg tablet in comparison to other starch based disintegrants including native enset starch (ES), sodium starch glycolate (SSG) and pregelatinized starch 1500® (PGS 1500). ASA is a moisture-sensitive drug and can be hydrolyzed into acetic and salicylic acid when exposed to high humidity and elevated temperature. As the coating process will subject ASA tablets to both high temperature and humidity, it is important that the formulation exhibit minimum interaction with the aqueous coating solution. The study began with the development of an optimum coating technique, which can offer the maximum mechanical and chemical stability and other pertinent tablet qualities but minimum exposure time to the coating solution to the tablet. Then, to investigate the effect of the type and quantity of the disintegrant on stability and other tablet attributes, twelve different ASA 81 mg tablet formulations, containing three different levels of the above four disintegrants, were directly compressed using microcrystalline cellulose (MCC) as a direct compression filler and talc as a lubricant and characterized. The tablets were then coated using enteric coating polymer Wangit L30D-55 (aqueous dispersion of methacrylic acid-ethyl acrylate copolymers) by conventional pan coating technique and were further characterized. Finally, the tablets were subjected to a three month accelerated stability study conditions and the stability of the tablets was assessed based on coat integrity, assay results and change in the level of free salicylic acid within the formulation. The results of the study showed that the uncoated tablets had the desired attributes including tablet weight variation, friability, hardness, disintegration time and dissolution time results which were well within the acceptable limits of the USP 30-NF 25 (2007) standards. Results of the three month accelerated stability study showed that tablets formulated with sodium starch glycolate were unstable and resulted in softening and sticking of the coat. Besides, there was a significant increase in free salicylic acid percentage and release of drug in the acidic stage. Unlike tablets formulated with sodium starch glycolate, tablets formulated with the pregelatinized starches, pregelatinized enset starch and starch 1500® as disintegrants maintained their appearance and the cumulative percent drug release in 0.1 N HCl and buffer stage. Percent free salicylic acid, assay results and other tablet attributes unchanged except tablet hardness, which was also within the acceptable limit. Tablets prepared with ES were stable but ES was inferior as tablet disintegrant. Therefore, pregelatinized enset starch can be used as a better alternative to sodium starch glycolate and as a replacement to pregelatinized starch 1500® as tablet disintegrant in those formulation that contain moisture susceptible drugs.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Enset starch; Disintegrant; Stability; Enteric coated; Acetylsalicylic Acid; Pregelatinized starch, Sodium starch glycolate |
| Subjects: | Q Science > Q Science (General) R Medicine > RS Pharmacy and materia medica |
| Divisions: | Africana |
| Depositing User: | Vincent Mpoza |
| Date Deposited: | 04 Jul 2018 14:24 |
| Last Modified: | 04 Jul 2018 14:24 |
| URI: | http://thesisbank.jhia.ac.ke/id/eprint/6635 |
Actions (login required)
 |
View Item |