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基于普鲁兰多糖的铁口腔崩解膜的研制与表征

Development and Characterization of Pullulan-Based Orodispersible Films of Iron.

作者信息

Gupta Maram Suresh, Kumar Tegginamath Pramod, Reddy Dinesh, Pathak Kamla, Gowda Devegowda Vishakante, Babu A V Naresh, Aodah Alhussain H, Khafagy El-Sayed, Alotaibi Hadil Faris, Abu Lila Amr Selim, Moin Afrasim, Hussin Talib

机构信息

Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysore 570015, India.

Aavishkar Oral Strips Private Limited, Plot No. 109/3, Phase-II, Sector 2, Lane No. 6 IDA Cherlapally, Hyderabad 500051, India.

出版信息

Pharmaceutics. 2023 Mar 22;15(3):1027. doi: 10.3390/pharmaceutics15031027.

Abstract

Iron deficiency is the principal cause of nutritional anemia and it constitutes a major health problem, especially during pregnancy. Despite the availability of various non-invasive traditional oral dosage forms such as tablets, capsules, and liquid preparations of iron, they are hard to consume for special populations such as pregnant women, pediatric, and geriatric patients with dysphagia and vomiting tendency. The objective of the present study was to develop and characterize pullulan-based iron-loaded orodispersible films (i-ODFs). Microparticles of iron were formulated by a microencapsulation technique, to mask the bitter taste of iron, and ODFs were fabricated by a modified solvent casting method. Morphological characteristics of the microparticles were identified by optical microscopy and the percentage of iron loading was evaluated by inductively coupled plasma optical emission spectroscopy (ICP-OES). The fabricated i-ODFs were evaluated for their morphology by scanning electron microscopy. Other parameters including thickness, folding endurance, tensile strength, weight variation, disintegration time, percentage moisture loss, surface pH, and in vivo animal safety were evaluated. Lastly, stability studies were carried out at a temperature of 25 °C/60% RH. The results of the study confirmed that pullulan-based i-ODFs had good physicochemical properties, excellent disintegration time, and optimal stability at specified storage conditions. Most importantly, the i-ODFs were free from irritation when administered to the tongue as confirmed by the hamster cheek pouch model and surface pH determination. Collectively, the present study suggests that the film-forming agent, pullulan, could be successfully employed on a lab scale to formulate orodispersible films of iron. In addition, i-ODFs can be processed easily on a large scale for commercial use.

摘要

缺铁是营养性贫血的主要原因,构成了一个重大的健康问题,尤其是在孕期。尽管有各种非侵入性的传统口服剂型,如铁剂片剂、胶囊和液体制剂,但对于孕妇、儿童以及有吞咽困难和呕吐倾向的老年患者等特殊人群来说,这些剂型难以服用。本研究的目的是开发并表征基于普鲁兰多糖的载铁口腔崩解膜(i-ODF)。通过微囊化技术制备铁微粒以掩盖铁的苦味,并采用改良的溶剂浇铸法制备口腔崩解膜。通过光学显微镜确定微粒的形态特征,并用电感耦合等离子体发射光谱法(ICP-OES)评估铁的负载百分比。通过扫描电子显微镜对制备的i-ODF进行形态评估。还评估了其他参数,包括厚度、耐折性、拉伸强度、重量差异、崩解时间、水分损失百分比、表面pH值以及体内动物安全性。最后,在25℃/60%相对湿度的条件下进行稳定性研究。研究结果证实,基于普鲁兰多糖的i-ODF具有良好的理化性质、优异的崩解时间以及在特定储存条件下的最佳稳定性。最重要的是,通过仓鼠颊囊模型和表面pH值测定证实,i-ODF给药于舌头时无刺激性。总体而言,本研究表明,成膜剂普鲁兰多糖可以在实验室规模上成功用于制备铁口腔崩解膜。此外,i-ODF可以很容易地进行大规模加工以供商业使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4122/10056616/95d358d72ac2/pharmaceutics-15-01027-g001.jpg

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