新型羟考酮多单位缓释微丸体系的研制与评价

European Pharmaceutical Journal Pub Date : 2019-11-01 DOI:10.2478/afpuc-2019-0019

Š. Husár, M. Sýkorová, K. Rumlová, K. Chomaničová, B. Vladovičová

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引用次数: 0

摘要

摘要本研究的目标是制备一种稳定的、多单位的、缓释的剂型，含有涂有乙基纤维素（EC）水性分散体的羟考酮颗粒，Surelease E-7-19050。施用18%w/w的EC导致与含有20mg羟考酮的疏水性、非溶胀性基质参考产物类似的药物释放。将压缩力增加到9kN，并将超过50%w/w的羟考酮颗粒加入制剂中，导致更快的药物释放，表明对EC薄膜涂层的破坏。最终制剂的物理外观、羟考酮的测定、水分含量和稳定期内的溶解数据表明，多元颗粒系统（MUPS）对于生产高度稳定的产品是有效的。

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Formulation and evaluation of new oxycodone extended release multiple unit pellet system

Abstract The goal of the present study is to prepare a stable, multiple-unit, extended-release dosage form containing oxycodone pellets coated with aqueous ethylcellulose (EC) dispersion, Surelease E-7-19050. The application of 18% w/w of EC leads to the similar drug release with the hydrophobic, non-swelling, matrix reference product containing 20 mg of oxycodone. Increasing the compression force to 9 kN and including more than 50% w/w of oxycodone pellets into the formulation resulted in faster drug release, indicating the damaging to the EC film coating. The physical appearance of the final formulation, assay of oxycodone, moisture content, and dissolution data over the stability period showed that the multiple-unit pellet system (MUPS) is efficient for the production of highly stable product.

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来源期刊

European Pharmaceutical Journal Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

0.60

自引率

0.00%

发文量

期刊介绍： European Pharmaceutical Journal publishes only original articles not previously published and articles that are not being considered or have not been submitted for publication elsewhere. If parts of the results have been published as conference abstract or elsewhere, it should be stated in references. The ethical standards of the Helsinki-Tokio Declaration should be kept. This should be mentioned in the Methods of manuscript. Reviews are published only on request. Authors, whose submitted research work was performed with the support of a company, should indicate this in Conflict of Interest.