Abstract
Purpose: To prepare and characterize alcohol-alkaline modified rice starch (MRS) as a disintegrant for tablets. Methods: The preparation of MRS was carried out using 3 M NaOH and 40 % ethanol solution. Characterization carried out for MRS include morphology, swelling capacity, thermal and pasting properties. Direct-compressed tablets (DCT) containing either propranolol hydrochloride (PPNL) or hydrochlorothiazide (HCTZ) were evaluated for hardness, friability, disintegration time and drug release. Results: The microstructure of MRS was different in shape and dimension from that of rice starch (RS). The absence of gelatinization endotherm and FT-IR spectral peak for MRS correlated with change in MRS structure and arrangement. MRS showed significantly higher swelling capacity (p < 0.05) than RS, and also proved to be a disintegrant in DCT. The disintegration time of the tablets containing MRS was lower in the presence of large particles (3.55 ± 0.56 min); high content of MRS (1.03 ± 0.06 min); low content of lubricant (3.16 ± 0.44 min); water soluble filler (1.55 ± 0.16 min for Super-tab®); and model drug (0.84 ± 0.09 min for HCTZ) (p < 0.05). Conclusion: MRS exhibits improved water solubility and swelling capacity compared with RS, and is thus a good disintegrant for direct-compressed tablet formulations, especially in the presence of water insoluble fillers. Keywords: Rice starch, Alcohol-alkaline treatment, Disintegrant, Directly compressed tablet, Insoluble fillers
Highlights
Fast-release tablet is one of the widely used dosage forms for oral administration because of convenience and short onset of action, and tablet production by direct compression method is very popular due to the simplicity, low cost and efficiency [1]
rice starch (RS) particles had a polygonal shape with 3 - 10 μm diameter (Figures 1a and 1b), whereas morphology of modified rice starch (MRS) showed irregular particles with diameter size about 58 – 156 μm (Figures 1c and 1d)
The Differential scanning calorimetry (DSC) pattern of RS showed the temperature of onset, peak and end of gelatinization at 73.22, 75.45 and 79.70 oC, respectively, whereas MRS did not show gelatinization endotherm in the temperature range of 30 – 120 oC (Figure 2), due likely to changes in the internal structure of starch granule during the modification process
Summary
Fast-release tablet is one of the widely used dosage forms for oral administration because of convenience and short onset of action, and tablet production by direct compression method is very popular due to the simplicity, low cost and efficiency [1]. Alcoholic-alkaline treatment is a simple and inexpensive method of the modification of starch that confers better swelling and higher water solubility at room temperature [6]. This method has been used to modify several starches, such as corn starch, waxy corn starch and sago starch [6,8,9]. The RS modification could possibly improve swelling and water solubility for use in this purpose
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