Development and characterization of bimodal chrono modulated drug delivery of methylphenidate hydrochloride

IF 4.6 Q1 CHEMISTRY, APPLIED
Rajasekhar Reddy Poonuru, Ashwini Penala
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Abstract

The study's goal was to develop chrono modulated pulsatile tablets of methylphenidate hydrochloride with an extended-release pattern in the morning and an immediate burst release in the afternoon for exaggerated symptoms of attention deficit hyperactivity disorder match the circadian rhythm of disease, where high levels of l-3, 4-dihydroxyphenylalanine (DOPA) are observed in the afternoon, necessitating higher drug concentrations. The core tablets were made with Kollidon CL-SF as a super disintegrant at 4% and 8% concentrations, with microcrystalline cellulose PH 102 (Pharma grade) and Ludipress as diluents.

The core tablets were then compress coated with a slow-release component blend containing different grades of hydroxypropyl methylcellulose (HPMC) at various concentrations of HPMC E50, HPMC E15M, or HPMC E4M, as well as 4% Ethocel. Among all formulations, the F10 formulation containing HPMC E50 at 70% showed the best drug release, with 60% of the dose released slowly over 4 h, followed by an immediate burst of the remaining 40% at the 5th hour. The effect of different diluents on in vitro drug release kinetics and in vitro dissolution studies were performed for all formulations, and A1 formulation containing Cellactose-80 as a diluent showed the best results, with results matching the circadian variations in the disease condition.

Abstract Image

盐酸哌醋甲酯双峰时调给药的研制与表征。
该研究的目标是开发时间调节的脉冲片剂盐酸哌醋甲酯,上午有缓释模式,下午有立即爆发释放,用于治疗注意缺陷多动障碍的夸大症状,与疾病的昼夜节律相匹配,下午观察到高水平的l- 3,4 -二羟基苯丙氨酸(DOPA),需要更高的药物浓度。以PH为102的微晶纤维素(制药级)和Ludipress为稀释液,以Kollidon CL-SF为超级崩解剂,浓度分别为4%和8%。然后用含有不同等级羟丙基甲基纤维素(HPMC)、不同浓度HPMC E50、HPMC E15M或HPMC E4M以及4%乙醇的缓释组分共混物对核心片进行压缩包膜。在所有制剂中,含70% HPMC E50的F10制剂释放效果最好,其中60%的剂量在4 h内缓慢释放,剩余40%的剂量在第5 h立即释放。对所有制剂进行了不同稀释剂对体外药物释放动力学和体外溶出度的影响研究,其中以纤维素糖-80为稀释剂的A1制剂效果最好,其结果与疾病状况的昼夜变化相吻合。
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
CiteScore
4.50
自引率
0.00%
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审稿时长
61 days
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