Harimurti Sabtanti, Rahma Nabila Khaula, Sukamdi Dyani Primasari, Widada Hari, Makiyah Sri Nabawiyati Nurul, Kesetyaningsih Tri Wulandari, Ghozali Muhammad Thesa, Susanti Hari
Department of Pharmaceutical Chemistry, School of Pharmacy, Universitas Muhammadiyah Yogyakarta, Yogyakarta, Indonesia.
Department of Pharmaceutical Technology, School of Pharmacy, Universitas Muhammadiyah Yogyakarta, Yogyakarta, Indonesia.
J Adv Pharm Technol Res. 2025 Jul-Sep;16(3):125-132. doi: 10.4103/JAPTR.JAPTR_381_24. Epub 2025 Aug 9.
Gelatin, commonly used for capsule shells, is mostly imported from Europe and America to Indonesia. However, Indonesia's rich biodiversity offers abundant natural alternatives like arrowroot and alginate. The need for local raw material independence in pharmaceuticals drives this research. This study aims to determine whether arrowroot starch and sodium alginate with calcium chloride as a crosslinker can replace gelatin capsule shells. This study involved five capsule shell formulas (F1-F5), with evaluations on characteristics, swelling %, disintegration time, dispersive X-ray, Fourier-transform infrared (FTIR) analysis, and simplex lattice design (SLD) method optimization, using commercial capsules (CCs) as a control. We used the one-sample -test. F3 showed the best results in weight uniformity (0.22 ± 0.01 g), %swelling (45.84 ± 0.08%), and disintegration time (8.22 ± 0.85 min), compared to the CC, i.e., weight uniformity (0.12 ± 0.003 g), %swelling (43.26 ± 0.03%), and disintegration time (6.19 ± 1.38 min). Morphologically, F3 was the most homogeneous, resembling CC. FTIR analysis showed hydroxyl band from carboxylic group shifts indicating crosslinking, with notable changes from 1416.6 to 1386.9/cm in F3 and 1417.7-1394.0/cm in F5 after CaCl₂ addition. SLD validation was performed on three model-generated equations using experimental data. The differences between predicted and experimental results were 34.54% (weight uniformity), 3.12% (swelling), and 5.35% (disintegration time). A one-sample -test showed no significant differences (α > 0.05). Arrowroot starch and sodium alginate with calcium chloride crosslinker can be used as an alternative to capsule shells.
明胶常用于胶囊壳,大多从欧美进口至印度尼西亚。然而,印度尼西亚丰富的生物多样性提供了诸如竹芋和海藻酸盐等丰富的天然替代品。制药领域对本地原材料独立性的需求推动了这项研究。本研究旨在确定以氯化钙为交联剂的竹芋淀粉和海藻酸钠是否能够替代明胶胶囊壳。本研究涉及五种胶囊壳配方(F1 - F5),对其特性、溶胀率、崩解时间、色散X射线、傅里叶变换红外光谱(FTIR)分析以及使用单纯形格子设计(SLD)方法进行优化,并以市售胶囊(CCs)作为对照。我们采用单样本检验。与市售胶囊相比,F3在重量均匀度(0.22±0.01 g)、溶胀率(45.84±0.08%)和崩解时间(8.22±0.85分钟)方面表现出最佳结果,即市售胶囊的重量均匀度为(0.12±0.003 g)、溶胀率为(43.26±0.03%)和崩解时间为(6.19±1.38分钟)。在形态上,F3最为均匀,与市售胶囊相似。FTIR分析表明,羧酸基团的羟基带发生位移,表明发生了交联,添加氯化钙后,F3中从1416.6/cm至1386.9/cm以及F5中从1417.7/cm至1394.0/cm有显著变化。使用实验数据对三个模型生成的方程进行了SLD验证。预测结果与实验结果之间的差异分别为34.54%(重量均匀度)、3.12%(溶胀)和5.35%(崩解时间)。单样本检验表明无显著差异(α>0.05)。以氯化钙为交联剂的竹芋淀粉和海藻酸钠可作为胶囊壳的替代品。