Preparation of Loratadine Orally Disintegrating Tablets by Semi-solid Extrusion 3D Printing.

IF 2.8 4区医学 Q2 PHARMACOLOGY & PHARMACY

Current drug delivery Pub Date : 2023-01-01 DOI:10.2174/1567201819666221011094913

Shaoling Yi, Jingwen Xie, Lingli Chen, Feng Xu

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引用次数: 1

Abstract

Background: The orally disintegrating tablets (ODTs) are especially suitable for elders and children with dysphagia, who need to be given customized dosages.

Objectives: This study aimed to prepare orally disintegrating tablets (ODTs) which can be customized as drug content by using semi-solid 3D printing pressure extrusion technology, with water insoluble and thermally unstable drug loratadine.

Methods: The influence of binder concentration, disintegrating agent dosage and ratio mannitol: cellulose on formability and disintegration time was investigated. The properties of orally disintegrating tablets were investigated by ATR-FTIR, XRPD, DSC and SEM. The correlation formula between tablet bottom area and drug content was established.

Results: The formulation was optimized, and contained loratadine 3 g, cellulose 4 g, mannitol 2 g, carboxy methyl starch sodium 1g, 6% PVP K30 16 ml. The disintegration time was less than 60 s with infilling percentage of 60%, and the disintegration time was less than 30 s with infilling percentage of 40%. There was no detectable interaction between loratadine and the selected excipients by the analysis of ATR-FTIR, DSC and XRPD. The structure of the tablets was porous, and the drug was dissolved completely within 10 min. The drug content (x) of the tablet and the bottom area (y) of the tablet showed a linear fitting relationship, y = 3.8603x - 0.7176, r² = 0.9993.

Conclusion: Semi-solid extrusion of 3D printing technology was applied to prepare loratadine orally disintegrating tablets with customized drug content, which provides an alternative method for the research of customized preparation.

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半固态挤压3D打印制备氯雷他定口腔崩解片。

背景:口腔崩解片(ODTs)特别适用于老年人和儿童吞咽困难患者，需要定制剂量。目的:以不溶于水、热不稳定的药物氯雷他定为原料，采用半固态3D打印压力挤压技术制备可根据药物含量定制的口腔崩解片。方法:考察粘结剂浓度、崩解剂用量及甘露醇与纤维素的配比对成型性和崩解时间的影响。采用ATR-FTIR、XRPD、DSC和SEM对口腔崩解片的性质进行了表征。建立了片底面积与药物含量的相关关系式。结果:优化后的配方为氯雷他定3 g、纤维素4 g、甘露醇2 g、羧甲基淀粉钠1g、6% PVP K30 16 ml，填充率60%时崩解时间小于60 s，填充率40%时崩解时间小于30 s。经ATR-FTIR、DSC和XRPD分析，氯雷他定与所选辅料之间无相互作用。该片剂结构多孔，10 min内药物完全溶解，片剂的药物含量(x)与片剂底面积(y)呈线性拟合关系，y = 3.8603x - 0.7176, r2 = 0.9993。结论:采用半固态挤压3D打印技术制备定制药物含量的氯雷他定口腔崩解片，为定制制剂研究提供了另一种方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current drug delivery PHARMACOLOGY & PHARMACY-

CiteScore

5.10

自引率

4.20%

发文量

170

期刊介绍： Current Drug Delivery aims to publish peer-reviewed articles, research articles, short and in-depth reviews, and drug clinical trials studies in the rapidly developing field of drug delivery. Modern drug research aims to build delivery properties of a drug at the design phase, however in many cases this idea cannot be met and the development of delivery systems becomes as important as the development of the drugs themselves. The journal aims to cover the latest outstanding developments in drug and vaccine delivery employing physical, physico-chemical and chemical methods. The drugs include a wide range of bioactive compounds from simple pharmaceuticals to peptides, proteins, nucleotides, nucleosides and sugars. The journal will also report progress in the fields of transport routes and mechanisms including efflux proteins and multi-drug resistance. The journal is essential for all pharmaceutical scientists involved in drug design, development and delivery.