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以富含匙羹藤酸提取物的口腔崩解剂型作为一种适用于儿科患者的便捷制剂

Orodispersible Dosage Forms with Rhinacanthin-Rich Extract as a Convenient Formulation Dedicated to Pediatric Patients.

作者信息

Suksawat Thongtham, Brniak Witold, Łyszczarz Ewelina, Wesoły Małgorzata, Ciosek-Skibińska Patrycja, Mendyk Aleksander

机构信息

Faculty of Pharmacy, Mahidol University, Bangkok 10400, Thailand.

Department of Pharmaceutical Technology and Biopharmaceutics, Faculty of Pharmacy, Jagiellonian University Medical College, Medyczna 9, 30-688 Krakow, Poland.

出版信息

Pharmaceuticals (Basel). 2024 Jul 27;17(8):994. doi: 10.3390/ph17080994.

DOI:10.3390/ph17080994
PMID:39204099
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11356918/
Abstract

Rhinacanthins, derived from , widely used in traditional medicine, exhibit antifungal, anticancer, antiviral, antibacterial, and antiplatelet aggregation effects. Recently, their anti-diabetic activity was confirmed, which makes them an interesting natural alternative in the therapy of the early stage of diabetes mellitus. The aim of this study was to demonstrate the possibility of formulating orodispersible tablets (ODTs) and orodispersible films (ODFs) containing rhinacanthin-rich extract (RRE). Tablets with 50 mg or 100 mg of RRE were produced by direct compression. ODFs were manufactured by casting of Lycoat RS 720 or polyvinyl alcohol solution with RRE and additional excipients. The mechanical properties and disintegration times of the prepared formulations were studied. The effectiveness of taste masking was analyzed with an electronic tongue system. Six months simplified stability studies were performed in conditions complying to ICH guidelines. Appropriate friability of ODTs was achieved, despite low tensile strength (0.45-0.62 MPa). All prepared ODFs successfully met the acceptance criteria regarding Young's modulus, tensile strength, and elongation at break. The observed variations in their mechanical properties were dependent on the type and quantity of polymers and plasticizers used. Disintegration time of ODTs ranged from 38.7 s to 54.2 s, while for ODFs from 24.2 to 40 s in the pharmacopoeial apparatus. Analyses made with the electronic tongue showed the significant taste-masking effect in both formulations. The addition of sucralose as a sweetener and menthol with mint flavor as a taste-masking agent was sufficient to mask an RRE's taste in the case of ODTs and ODFs. Stability studies of ODTs packed in the PVC/Alu blisters showed a decrease in the RRE content below 90% after 6 months. However, ODFs with PVA were physicochemically stable for 6 months while being stored in Alu/Alu sachets. Our study proved for the first time the possibility of the formulation of orodispersible dosage forms with RRE, characterized by good mechanical properties, disintegration time, and appropriate taste masking.

摘要

来源于 的匙羹藤酸在传统医学中广泛应用，具有抗真菌、抗癌、抗病毒、抗菌和抗血小板聚集作用。最近，其抗糖尿病活性得到证实，这使其成为糖尿病早期治疗中一种有吸引力的天然替代物。本研究的目的是证明制备含富含匙羹藤酸提取物（RRE）的口腔崩解片（ODTs）和口腔崩解膜（ODFs）的可能性。通过直接压片制备了含50mg或100mg RRE的片剂。ODFs是通过将Lycoat RS 720或聚乙烯醇溶液与RRE及其他辅料浇铸而成。研究了所制备制剂的机械性能和崩解时间。用电子舌系统分析了掩味效果。在符合ICH指南的条件下进行了为期6个月的简化稳定性研究。尽管拉伸强度较低（0.45 - 0.62MPa），ODTs仍具有适当的脆碎度。所有制备的ODFs在杨氏模量、拉伸强度和断裂伸长率方面均成功符合验收标准。观察到的它们机械性能的变化取决于所用聚合物和增塑剂的类型和数量。在药典装置中，ODTs的崩解时间为38.7秒至54.2秒，而ODFs的崩解时间为24.2至40秒。电子舌分析表明两种制剂均有显著的掩味效果。在ODTs和ODFs的情况下，添加三氯蔗糖作为甜味剂和薄荷味薄荷醇作为掩味剂足以掩盖RRE的味道。包装在PVC/铝泡罩中的ODTs稳定性研究表明，6个月后RRE含量降至90%以下。然而，含聚乙烯醇的ODFs在储存在铝/铝小袋中时，在6个月内物理化学性质稳定。我们的研究首次证明了用RRE制备口腔崩解剂型的可能性，其具有良好的机械性能、崩解时间和适当的掩味效果。

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