Gashaw Solomon, Getachew Afewerk, Mola Fantahun
Mekelle University, College of Health Sciences, School of Pharmacy, Department of Pharmaceutics, Mekelle, Ethiopia.
Addis Ababa University, College of Health Sciences, School of Pharmacy, Department of Pharmaceutics and Social Pharmacy, Addis Ababa, Ethiopia.
Adv Pharmacol Pharm Sci. 2024 May 29;2024:6560070. doi: 10.1155/2024/6560070. eCollection 2024.
Corn, wheat, rice, potato, and cassava starches have been widely used as pharmaceutical excipients. However, the search for cost-effective local starch alternatives is necessary due to the availability and usage constraints. In Ethiopia, various plant species, including Taro Boloso-I, have been explored as potential sources of pharmaceutical starch. It is a variety of with a high tuber yield and high starch content. However, the native starch requires modifications to enhance its functionality. Therefore, this study aimed to improve the native starch through acid modification and evaluate its performance as a direct compressible tablet excipient. The native starch was treated with a 6% w/v HCl solution for 192 hours, resulting in acid-modified Taro Boloso-I starch, which was then evaluated for suitability for direct compression. XRD patterns of both the native and modified starch showed characteristic A-type crystals, with significantly higher relative crystallinity observed in the latter. Additionally, the acid-modified starch exhibited a lower moisture content and improved flow properties. The compaction study also demonstrated its improved compactibility (tensile strength: 16.82 kg/cm), surpassing both the native starch (13.17) and Starch 1500® (11.2). The modified starch also showed a lower lubricant sensitivity compared to the native starch and Starch 1500®. Furthermore, paracetamol tablets made with the modified starch exhibited higher mechanical strength and lower friability in all paracetamol concentrations. It incorporated up to 40% paracetamol while maintaining acceptable tablet characteristics, whereas the native starch and Starch 1500® were limited to 30% (w/w). Based on these findings, the modified starch showed promise as an alternative direct compressible excipient in tablet manufacturing.
玉米、小麦、大米、马铃薯和木薯淀粉已被广泛用作药物辅料。然而,由于可用性和使用限制,寻找具有成本效益的本地淀粉替代品是必要的。在埃塞俄比亚,包括博洛索一号芋头在内的各种植物物种已被探索作为药用淀粉的潜在来源。它是一种块茎产量高、淀粉含量高的品种。然而,天然淀粉需要改性以增强其功能。因此,本研究旨在通过酸改性改善天然淀粉,并评估其作为直接压片辅料的性能。将天然淀粉用6%(w/v)盐酸溶液处理192小时,得到酸改性的博洛索一号芋头淀粉,然后评估其直接压缩的适用性。天然淀粉和改性淀粉的X射线衍射图谱均显示出特征性的A型晶体,后者的相对结晶度明显更高。此外,酸改性淀粉的水分含量较低,流动性得到改善。压实研究还表明其压实性得到改善(抗张强度:16.82 kg/cm),超过了天然淀粉(13.17)和Starch 1500®(11.2)。与天然淀粉和Starch 1500®相比,改性淀粉对润滑剂的敏感性也较低。此外,用改性淀粉制成的对乙酰氨基酚片在所有对乙酰氨基酚浓度下均表现出更高的机械强度和更低的脆碎度。它可掺入高达40%的对乙酰氨基酚,同时保持可接受的片剂特性,而天然淀粉和Starch 1500®的限量为30%(w/w)。基于这些发现,改性淀粉有望成为片剂制造中替代直接压片辅料的选择。