Weldegiorgis, Gebregziabiher (2016) Preparation and Characterization of Enset Starch Citrate as a Disintegrant in Tablets. Masters thesis, Addis Ababa University.
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Abstract
Maize, cassava, wheat and potato are the main botanical origins for starch production with only minor quantities of rice. Physical and chemical modifications have been used to change the granular structure of starch and modify their functional properties to eliminate some of the undesirable properties, making them more suitable for specific uses. As native starches are poor disintegrants, they have been modified to improve their swellability and hence their disintegration efficiency in matrix tablets. The main objective of this study is to prepare enset starch citrate and investigate its disintegration capacity in tablet formulations. In this study, enset and potato starches were modified by chemical method under dry reaction conditions. Starch citrates of both starches were obtained under heterogeneous conditions as a product of the reaction of starch and citric acid in the presence of sodium hydroxide at eight different reaction conditions in each starch. The influences of pH of medium, reaction temperature and moisture content on the reaction process were investigated by treating both starches under acidic conditions. The disintegration capacity of the enset starch citrate (ESC) was evaluated in ibuprofen tablets compressed by direct compression method. Ibuprofen, a practically insoluble drug was used as a model drug. The starch citrates (SCs) prepared were studied for their gelling property, swelling power and solubility, settling volume, morphology, degree of substitution (DS), hydration capacity and moisture sorption profiles. A three level factorial design with two replicates at the center was used to study the influences of compression force and ESC levels on disintegration time (DT), hardness and friability. The results indicated that ESC is a potential disintegrant; SCs showed greater settling volume at neutral pH than in acidic medium; and ESC attained a swelling power of 1500% at 65 0C. The DS of the ESC selected for the formulation was 0.11 and with a hydration capacity of 6.43 g/g. The SCs had higher settling volume in distilled water (DW) than in acidic medium. The SCs prepared were more hygroscopic than the native starch. Ibuprofen and ESC compatibility study by Differential Scanning Colorimetry (DSC) indicated that there is no incompatibility between them. Scanning Electron Micrograph (SEM) images of the ESC revealed that the granule characteristic is completely different from that of the native enset starch (NES). The comparative study of ibuprofen tablets containing ESC and sodium starch II glycolate (SSG) as disintegrants also revealed the superiority of SSG although the ESC produced harder tablets than SSG. Ibuprofen tablets included in the study design revealed that the disintegration times (DT) of the tablets ranged between 25 and 187 sec.; hardness ranged from 62.7 to 151 N, while friability ranged from 0.09 to 0.17%. Simultaneous optimization of DT, hardness and friability provided values of 25 sec, 84.3 N and 0.14%, respectively at compression force of 5.15 KN and ESC concentration of 4% respectively as the optimum point. Dissolution study of the optimized formulation fulfilled USP requirements. The optimized formulation was validated and it was confirmed that the predicted and measured values were in agreement. Therefore, it can be concluded that ESC can be used as an alternative disintegrant in insoluble drug tablet formulations.
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Enset starch, Enset starch citrate, Citric acid, Disintegrant, Optimization |
| Subjects: | Q Science > Q Science (General) |
| Divisions: | Africana |
| Depositing User: | Vincent Mpoza |
| Date Deposited: | 13 Jul 2018 09:07 |
| Last Modified: | 13 Jul 2018 09:07 |
| URI: | http://thesisbank.jhia.ac.ke/id/eprint/7397 |
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