Pratiksha Institute of Pharmaceutical sciences, Guwahati, Assam 781026, India; Assam Science and Technology University, Guwahati, Assam 781013, India.
Girijananda Chowdhury Institute of Pharmaceutical Sciences, Tezpur, Assam 784501, India.
Int J Biol Macromol. 2023 Jun 15;240:124475. doi: 10.1016/j.ijbiomac.2023.124475. Epub 2023 Apr 17.
Assam soft rice starch (ASRS) and Citric acid-esterified Assam soft rice starch (c-ASRS) were studied extensively. FTIR, CHN, DSC, XRD, SEM, TEM and optical microscope studies were performed for native and modified starches. Powder rearrangements, cohesiveness and flowability were studied by the Kawakita plot. Moisture and ash content was around 9 % and 0.5 %. In vitro digestibility of ASRS and c-ASRS produced functional RS. Paracetamol tablets were prepared using ASRS and c-ASRS as granulating-disintegrating agents through wet granulation methods. The prepared tablets' physical properties, disintegrant properties, in vitro dissolution and dissolution efficiency (DE) were performed. The average particle size was obtained at 6.59 ± 0.355 μm and 8.15 ± 0.168 μm for ASRS and c-ASRS, respectively. All the results were statistically significant at p < 0.05, p < 0.01 and p < 0.001. The amylose content was 6.78 %, classifying it as a low amylose type of starch. The disintegration time was reduced with the increasing concentration of ASRS and c-ASRS and facilitated the immediate release of the model drug from the tablet compact to improve its bioavailability. Therefore, the current investigation concludes that ASRS and c-ASRS can be used as novel and functional materials in pharmaceutical industries due to their unique physicochemical attributes. HYPOTHESIS: The central hypothesis of the current work was to develop citrated starch through a one-step reactive extrusion method and investigate its disintegrants property for pharmaceutical tablets. Extrusion is a continuous, simple, high-speed, low-cost, producing very limited wastewater and gas. Characterization was done through different instrumental techniques to confirm successful esterification. The flow properties were evaluated, and tablets were prepared at a different level of ASRS and c-ASRS (disintegrating agent), followed by the evaluation of tablets to confirm the model drug's dissolution and disintegration efficiency. Finally, in vitro digestibility of both ASRS and c-ASRS was analyzed to establish their potential nutritional benefits.
阿萨姆邦软米淀粉（ASRS）和柠檬酸酯化阿萨姆邦软米淀粉（c-ASRS）被广泛研究。对天然淀粉和改性淀粉进行了傅里叶变换红外光谱（FTIR）、碳氢氮分析（CHN）、差示扫描量热法（DSC）、X 射线衍射（XRD）、扫描电子显微镜（SEM）、透射电子显微镜（TEM）和光学显微镜研究。通过川口图研究了粉末的重排、内聚性和流动性。水分和灰分含量约为 9%和 0.5%。ASRS 和 c-ASRS 的体外消化产生功能性 RS。通过湿法制粒法，使用 ASRS 和 c-ASRS 作为制粒-崩解剂制备对乙酰氨基酚片。对制备的片剂的物理性质、崩解剂性质、体外溶出度和溶出效率（DE）进行了研究。ASRS 和 c-ASRS 的平均粒径分别为 6.59±0.355μm 和 8.15±0.168μm。所有结果在 p<0.05、p<0.01 和 p<0.001 时均具有统计学意义。直链淀粉含量为 6.78%，属于低直链淀粉淀粉类型。随着 ASRS 和 c-ASRS 浓度的增加，崩解时间缩短，有利于模型药物从片剂中迅速释放，提高其生物利用度。因此，目前的研究得出结论，由于其独特的物理化学性质，ASRS 和 c-ASRS 可以用作制药工业中的新型功能性材料。假设：当前工作的中心假设是通过一步反应挤出法制备柠檬酸酯化淀粉，并研究其用于药物片剂的崩解剂性质。挤出是一种连续、简单、高速、低成本、产生非常有限的废水和气体的方法。通过不同的仪器技术进行特性分析，以确认酯化反应的成功。评估了流动性能，并在不同水平的 ASRS 和 c-ASRS（崩解剂）下制备了片剂，然后对片剂进行评估，以确认模型药物的溶出度和崩解效率。最后，分析了 ASRS 和 c-ASRS 的体外消化率，以确定它们的潜在营养价值。
