The chemical modifications of starch granules have been adopted to improve the characteristics, viz., paste clarity, resistant starch content, thermal stability, and so forth. The modified starch has been applied as a biopolymer in developing various preparations of food, nutraceutical, and pharmaceutical importance. The present work is focused on phosphorylation of alkali extracted mandua starch for improving digestion resistibility. The phosphorylation of mandua starch extracted from grains of Eleusine coracana (family Poaceae) was carried out by sodium tripolyphosphate/sodium trimetaphosphate at alkaline pH. After chemical treatment of mandua starch, the resistant starch (RS) content was increased significantly. The digestibility of chemically modified starch (CMS) was decreased down after treating by the phosphorylation process. The digestibility of CMS and alkali extracted mandua starch (AMS) in simulated intestinal fluid was found to be 32.64 ± 1.98% w/w and 61.12 ± 2.54% w/w, respectively. After chemical modification of mandua starch, a decrement was observed in amylose content, water-binding capacity, and swelling power. In the three-stage decomposition pattern of CMS studied by thermal gravimetric analysis, the significant changes in decomposition behavior also affirmed the impact of cross-linking in the improvement of stability of internal structure and resistibility of starch. In Fourier transform infrared (FTIR), the formation of the PO bond was observed in CMS at 1250 cm–1. The acute and sub-acute toxicity studies in terms of behavioral, haematological, and enzymological parameters for CMS were not different significantly from AMS and control (p > 0.05). The cellular architecture of the liver and the kidney were found normal after consumption of CMS. The results revealed that significant increment in RS fraction occurred after cross-linking of mandua starch. The prepared starch may be applied in developing various formulations of food and pharmaceutical importance.

Starch, being a polymer of excessive demand for the development of products of pharmaceutical importance, has been tremendously treated in many ways for improving the desired characteristics such as viscosity, paste clarity, digestibility, swelling, syneresis, and so forth. In the present study, alkali-extracted starch of mandua grains ( Eleusine coracana ; family Poaceae) was treated with epichlorohydrin for cross-linking and the modified starch was assessed for swelling, solubility, water binding capacity, moisture content, and degree of cross-linking. The digestion resistibility of modified starch was analyzed in simulated gastric fluid (pH 1.2), simulated intestinal fluid (pH 6.8), and simulated colonic fluid (pH 7.4). The structural modifications in treated mandua starch were analyzed by Fourier transform infrared (FTIR) spectroscopy, powder X-ray diffraction (XRD), scanning electron microscopy, thermogravimetric analysis, and C 13 nuclear magnetic resonance ( 13 C NMR). The results of the study reflected the significant modification in mandua starch after treatment with epichlorohydrin (1.0% w/w sdb, solid dry basis). The degree of cross-linking of treated mandua starch was 85.15%, and the swelling capacity of mandua starch changed from 226.51 ± 2.175 to 103.14 ± 1.998% w/w after cross-linking with epichlorohydrin. A remarkable increment in digestion resistibility was observed in modified mandua starch. The XRD pattern and FTIR spectra revealed the presence of resistant starch after chemical modification. The decomposition pattern of modified mandua starch was also different from extracted mandua starch. All the results reflected the effective modification of mandua starch by epichlorohydrin and the formation of resistant starch to a significant content. The treated mandua starch may have the potential in developing various preparations of food, nutraceuticals, and pharmaceuticals.

Pharmaceutical excipients are compounds or substances other than API which are added to a dosage form, these excipients basically act as carriers, binders, bulk forming agents, colorants, and flavouring agents, and few excipients are even used to enhance the activity of active pharmaceutical ingredient (API) and various more properties. However, despite of these properties, there are problems with the synthetic excipients such as the possibility of causing toxicity, inflammation, autoimmune responses, lack of intrinsic bioactivity and biocompatibility, expensive procedures for synthesis, and water solubility. However, starch as an excipient can overcome all these problems in one go. It is inexpensive, there is no toxicity or immune response, and it is biocompatible in nature. It is very less used as an excipient because of its high digestibility and swelling index, high glycemic index, paste clarity, film-forming property, crystalline properties, etc. All these properties of starch can be altered by a few modification processes such as physical modification, genetic modification, and chemical modification, which can be used to reduce its digestibility and glycemic index of starch, improve its film-forming properties, and increase its paste clarity. Changes in some of the molecular bonds which improve its properties such as binding, crystalline structure, and retrogradation make starch perfect to be used as a pharmaceutical excipient. This research work provides the structural modifications of native starch which can be applicable in advanced drug delivery. The major contributions of the paper are advances in the modification of native starch molecules such as physically, chemically, enzymatically, and genetically traditional crop modification to yield a novel molecule with significant potential for use in the pharmaceutical industry for targeted drug delivery systems.

In the present era, 28 days of repeated-dose-toxicity study following the Organization for Economic Cooperation and Development (OECD) guidelines 407 is compulsory for every drug to go through phase 1 clinical trials. The increasing demand for high-resistant starch containing nutraceuticals and the applicability of modified starch in development of targeted drug delivery inspired us to investigate the toxic profile of mandua starch chemically cross-linked by epichlorohydrin and compare it with alkaliisolated starch in healthy adult Swiss albino mice, which can be the first step for exploring the use of epichlorohydrin-cross-linked mandua starch (ECC-MS) as a pharmaceutical excipient. Histopathological examinations of the kidney and liver did not expose noteworthy abnormalities in the treated mice. There were no clinical and mortality symptoms of toxicity observed during the repeated-dose-toxicity study. The oral consumption of ECC-MS did not pose any harm as it was neither lethal nor had any harmful hematological, biochemical, psychological, anatomical, and behavioral effects. The use of ECC-MS and alkali-isolated mandua starch (AMS) was found safe at a dose of 2000 mg/kg body weight in the acute toxicity study and at doses of 2000, 1500, and 1000 mg/kg body weight in the sub-acute toxicity study as no detrimental effects were observed after oral administration in mice for 14 and 28 days, respectively.

The functional and tableting properties of barnyard millet starch (Echinochloa esculenta) were investigated in its native (alkali-treated) and chemically modified (phosphorylated) states. The grains were pulverized, soaked, and ground before filtration to separate starch and protein. Multiple NaOH treatments were performed. The starch was washed, neutralized, and dried. Sodium tripolyphosphate (STPP) and sodium sulfate were used to modify the starch, followed by maceration, washing, and drying to remove unreacted chemicals. The amylose content of alkali-treated barnyard millet starch increased by 19.96 ± 3.56% w/w. The amount of protein, the kind of starch used, and the size of the starch granules, all affected the ability of the starch granules to swell up. It was observed that alkali-extracted barnyard millet starch (AZS) has a swelling power of 194.3 ± 0.0064% w/w. The swelling capacity of treated starch was lesser as compared to the native alkali barnyard millet starch. Decrement in swelling power of phosphorylated starch was observed due to tightening of bonds in the molecular structure. The moisture content of the excipients may affect the overall stability of the formulation. The moisture content of the AZS was found to be 15.336 ± 1.012% w/w. Compared to AZS, cross-linked barnyard millet starch had a moisture content that was up to 20% lower than AZS. The Hausner ratio for phosphorylated starch was found to be 1.25, which indicates marked flow property. Similar morphologies could be seen in the alkali-isolated barnyard millet starch and the cross-linked/phosphorylated barnyard millet that was cross-linked using a mixture of sodium sulfate and sodium tripolyphosphate. The modest degree of substitution would have no effect on the surface morphology as shown by the scanning electron microscopic study. The crushing and compacting abilities of modified barnyard millet starch were also improved, but its friability and rate of disintegration were decreased. The whole study revealed that after cross-linking, barnyard millet had good tableting properties and it can be used as an excipient in drug delivery.