Ahmed Kawther Khalid, Kassab Hanan Jalal, Al Ramahi Intesar Jawad, Alwan Zahraa Salim
University of Baghdad, College of Pharmacy, Department of Pharmaceutics, Baghdad, Iraq.
Avi Sina Center for Pharmaceutical Research, Corporation of Research and Industry Development, Baghdad, Iraq.
Turk J Pharm Sci. 2024 Jan 19;20(6):352-360. doi: 10.4274/tjps.galenos.2023.24968.
Oral steroids are commonly prescribed to children. Steroids have a strong bitter taste that limits their oral acceptance in children. The objective of this study was to formulate a pediatric-friendly and palatable oral dosage form of steroids.
Solid dispersions of dexamethasone were prepared using polyethylene glycol, pectin, and Eudragit as carrier polymers, and chocolate as a flavoring agent. Taste masking efficiency was evaluated by healthy volunteers to select the best formula. The selected formula was pressed into chewable tablets with varying amounts of sweeteners. Chewable tablets were evaluated for palatability, hardness, and chewing index. The typical application of the taste masking approach was confirmed using prednisolone.
Eudragit-based solid dispersions were effective in dexamethasone taste masking. Using 40% mannitol resulted in palatable tablets with acceptable hardness and chewing difficulty. The effectiveness of the taste masking approach was successfully used to prepare prednisolone chewable tablets. However, an increase in the carrier: drug ratio and a change in the flavor to pineapple were necessary to achieve maximum palatability of prednisolone chewable tablets.
Eudragit solid dispersion is an effective method for the taste masking highly bitter steroids. The solid dispersion was successfully pressed into a palatable, easy-to-chew, and pediatric-friendly chewable tablet dosage form. The carrier: drug ratio and the choice of flavoring agent are crucial factors in improving tablet palatability.
口服类固醇药物常用于儿童。类固醇具有强烈的苦味，这限制了儿童对其口服的接受度。本研究的目的是研制一种对儿童友好且口感良好的类固醇口服剂型。
以聚乙二醇、果胶和丙烯酸树脂为载体聚合物，巧克力为调味剂，制备地塞米松固体分散体。通过健康志愿者评估掩味效果以选择最佳配方。将所选配方压制成含有不同量甜味剂的咀嚼片。对咀嚼片的口感、硬度和咀嚼指数进行评估。使用泼尼松龙证实了掩味方法的典型应用。
基于丙烯酸树脂的固体分散体对地塞米松有有效的掩味作用。使用40%的甘露醇可得到口感良好、硬度和咀嚼难度可接受的片剂。掩味方法的有效性成功用于制备泼尼松龙咀嚼片。然而，为了使泼尼松龙咀嚼片达到最大的适口性，需要提高载体与药物的比例并将调味剂改为菠萝味。
丙烯酸树脂固体分散体是一种有效掩蔽高苦味类固醇药物的方法。该固体分散体成功压制成口感良好、易于咀嚼且对儿童友好的咀嚼片剂型。载体与药物的比例和调味剂的选择是提高片剂适口性的关键因素。
