3D printed extended-release hydrochlorothiazide tablets

IF 4.3 3区 医学 Q1 PHARMACOLOGY & PHARMACY European Journal of Pharmaceutical Sciences Pub Date : 2024-12-24 DOI:10.1016/j.ejps.2024.106998
Teodora Tasevska , Ivana Adamov , Nikola Geskovski , Svetlana Ibrić , Katerina Goracinova , Maja Simonoska Crcarevska
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Abstract

In this study 3D printed tablets (printlets) with extended release of hydrochlorothiazide (HHT) as model active ingredient were designed and developed. Four formulations, F0.1SSE, F1SSE, F0.1DLP and F1DLP, have been manufactured and characterized, using non-typical semi-solid extrusion (SSE) with UV light solidification and digital light processing (DLP) techniques. Obtained rheological studies pointed out to F1SSE and F1DLP as more suitable for SSE and DLP printing, respectively. Photopolymerization process between photopolymer (PEGDA) and photoinitiator (DPPO; 0.1% and 1%) was investigated using FTIR, with PCA modeling utilized to analyze spectral variations over time and estimate crosslinking kinetics. SSE printlets averaged ∼6.5 mm in diameter, ∼3 mm in height and ∼110 mg in mass, while DLP printlets averaged ∼8.5 mm in diameter, ∼2.5 mm in height, with masses of ∼170 mg (F0.1DLP) and ∼220 mg (F1DLP). All four formulations complied to the requirements of European pharmacopeia for uniformity of dosage units of single dose preparations. In vitro release studies indicated extended-release profiles in both 0.1M Hydrochloric acid (HCl) and phosphate buffer pH 6.8 for SSE and DLP printlets. The release kinetics of HHT from the printlets were modeled to fit First order, Higuchi, Korsmeyer-Peppas and Hixson-Crowell equations and the most probable ones were determined based on the R2 values and Akaike information criterion. FTIR and Raman spectroscopic analyses of printlets confirmed the presence of characteristic peaks from both, HHT and excipients, as well as modifications in bonds due to the photopolymeric reaction.

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3D打印氢氯噻嗪缓释片。
本研究以氢氯噻嗪(HHT)缓释为模型有效成分,设计并开发了3D打印片剂。采用紫外光固化非典型半固态挤压(SSE)和数字光处理(DLP)技术制备了F0.1SSE、F1SSE、F0.1DLP和F1DLP四种配方,并对其进行了表征。得到的流变学研究表明,F1SSE和F1DLP分别更适合于SSE和DLP印刷。光聚合物(PEGDA)与光引发剂(DPPO)的光聚合过程0.1%和1%)进行了FTIR研究,利用PCA模型分析了光谱随时间的变化并估计了交联动力学。SSE打印件的平均直径为~ 6.5 mm,高度为~ 3 mm,质量为~ 110 mg,而DLP打印件的平均直径为~ 8.5 mm,高度为~ 2.5 mm,质量为~ 170 mg (F0.1DLP)和~ 220 mg (F1DLP)。四种制剂均符合欧洲药典对单剂量制剂剂量单位均匀性的要求。体外释放研究表明,SSE和DLP在0.1M盐酸(HCl)和pH为6.8的磷酸盐缓冲液中均有缓释。采用一阶方程、Higuchi方程、Korsmeyer-Peppas方程和Hixson-Crowell方程建立HHT的释放动力学模型,并根据R2值和Akaike信息准则确定最可能的HHT释放动力学。FTIR和拉曼光谱分析证实了HHT和赋形剂的特征峰的存在,以及由于光聚合反应引起的键的修饰。
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来源期刊
CiteScore
9.60
自引率
2.20%
发文量
248
审稿时长
50 days
期刊介绍: The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.
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