Physicochemical Characterization of Acid Modified Dioscorea Starch and its Evaluation as Directly Compressible Excipient and Disintegrant in Tablet Formulations

Tessema, Bilal (2014) Physicochemical Characterization of Acid Modified Dioscorea Starch and its Evaluation as Directly Compressible Excipient and Disintegrant in Tablet Formulations. Masters thesis, Addis Ababa University.

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Abstract

Starch is one of the most important and flexible food ingredients possessing value added attributes for innumerable industrial applications. Dioscorea abyssinica (Fam. Dioscoreaceae) is a potential source of starch for large scale production in Ethiopia. Starch is usually modified either chemically or physically to augment its convenience for industrial use. The choice of excipients remains a critical factor in pharmaceutical formulations. Acid modified dioscorea starch (AMDS) has been prepared by hydrolyzing with 6% (w/w) HCl solution at ambient conditions and evaluated as a multifunctional excipient i.e, its direct compressibility and disintegrant effect in tablet formulations. Some of the physicochemical properties of AMDS such as; densities, flow, swelling power, percentage solubility, moisture sorption, and compactability were determined and compared to those of native dioscorea starch (NDS) and Starch 1500®. The comparative direct compressibility and disintegrant effects of these starches in tablet formulations were also studied using paracetamol as a model drug and the resulting tablets were evaluated for their physico-mechanical properties. The results indicated that both swelling power and percent solubility of the starches were found to increase with increase in temperature; AMDS showed higher percent solubility 68.53%. Spray dried AMDS exhibited free flowing property with 21.37 ± 1.39° angle of repose and 13.24 ± 0.76 g/sec flow rate. The compaction study revealed that the tensile strength and disintegration time of the compact increases and percent friability decreases as compression force increases. The lubricant sensitivity test showed that spray dried AMDS and Starch 1500® tablets could be used with acceptable tablet characteristics up to 1% and 0.5% of magnesium stearate concentration, respectively. With regard to dilution potential, the spray dried AMDS could accommodate up to 40% paracetamol with acceptable criteria. The results also indicated that tablets prepared with AMDS and Starch 1500® exhibited comparable characteristics. An increase in concentration of AMDS and Starch 1500® as disintegrant provided tablets with increased crushing strength and decreased disintegration time and friability. The dissolution studies of the paracetamol tablets showed that the release of the drug was within acceptable range (quantity dissolved in 30 min ≥ 80%). Thus, it can be concluded that AMDS can be used as an alternative directly compressible excipient and disintegrant in tablet formulations. Keywords: Dioscorea starch; acid modified starch; spray drying; tablet; directly compressible excipient; disintegrant; lubricant sensitivity, dilution potential, D. abyssinica.

Item Type: Thesis (Masters)
Subjects: Q Science > Q Science (General)
R Medicine > R Medicine (General)
R Medicine > RM Therapeutics. Pharmacology
Divisions: Africana
Depositing User: Vincent Mpoza
Date Deposited: 04 Jul 2018 15:30
Last Modified: 04 Jul 2018 15:30
URI: http://thesisbank.jhia.ac.ke/id/eprint/6650

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