酮洛芬的体外溶出度试验:软胶囊和硬胶囊的研制及释放度评价

IF 0.4 4区 医学 Q4 PHARMACOLOGY & PHARMACY Acta poloniae pharmaceutica Pub Date : 2023-03-03 DOI:10.32383/appdr/158885
K. Karłowicz-Bodalska, T. Han, N. Sauer, W. Szlasa, Olga Szczepańska, N. Janicka, K. Wacławczyk, E. Kuchar, A. Wiela-Hojeńska
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引用次数: 0

摘要

酮洛芬属于一类应用广泛的非甾体抗炎药。它存在于多种剂量和各种形式的药物中。疗效与活性物质的释放速率有关,这取决于配方、组成物质的质量和溶解度。为了确定波兰药品市场上可买到的含有酮洛芬的药物产品的疗效,研究比较了特定配方和剂量中所含活性物质的释放特性,Ketokaps MAX,50 mg,软胶囊,Ketonal active,50 mg硬胶囊,Ketokeps MED,100 mg,软囊剂,Refastin,100 mg薄膜包衣片和Ketonal Forte,已经进行了100mg的薄膜包衣片剂。已在IV型流动装置中使用FaSSGF和FaSSIF生物等效介质测试药物释放。结果表明,50 mg的产品Ketokaps MAX与50 mg的市场产品Ketonal active相比,酮洛芬的释放时间更短,释放的活性物质达到最大浓度的速度更快。与100 mg的市场产物Refastin和100 mg的Ketonal Forte相比,100 mg的产品将获得相同的结果。体外研究证实,测试产品在活性物质的释放动力学方面存在显著差异。50 mg Ketokaps MAX和100 mg Ketokeps MED在更短的时间内达到c MAX。
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In vitro dissolution test of ketoprofene: development and evaluation of release from soft and hard gelatine capsules
Ketoprofen belongs to a group of widely used non-steroidal anti-inflammatory drugs (NSAIDs). It is found in several doses and various forms of medications. Therapeutic efficacy is related to the rate of release of the active substances, which depends on the formulation, the quality of the constituent substances and solubility. In order to determine the efficacy of drug products containing ketoprofen available on the pharmaceutical market in Poland, studies comparing the release profiles of the active substance contained in specific formulation and doses, Ketokaps MAX, 50 mg, soft capsules, Ketonal Active, 50 mg, hard capsules, Ketokaps MED, 100 mg, soft capsules, Refastin, 100 mg, film-coated tablets and Ketonal Forte, 100 mg, film-coated tablets have been conducted. Drug release has been tested using FaSSGF and FaSSIF bioequivalent media in a type IV flow apparatus. The results indicate that the product Ketokaps MAX, 50 mg has a shorter release time of ketoprofen and a faster reached maximum concentration of the released active substance than the market product Ketonal Active, 50 mg. The same outcomes will be achieved by the product Ketokaps MED, 100 mg compared to the market products Refastin, 100 mg and Ketonal Forte, 100 mg. In vitro studies confirm that the tested products differ noticeably in the kinetics of release of the active substance. Ketokaps MAX, 50 mg and Ketokaps MED, 100 mg achieve c max in a shorter time.
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来源期刊
CiteScore
0.80
自引率
0.00%
发文量
74
审稿时长
6-12 weeks
期刊介绍: The international journal of the Polish Pharmaceutical Society is published in 6 issues a year. The journal offers Open Access publication of original research papers, short communications and reviews written in English, in all areas of pharmaceutical sciences. The following areas of pharmaceutical sciences are covered: Analysis, Biopharmacy, Drug Biochemistry, Drug Synthesis, Natural Drugs, Pharmaceutical Technology, Pharmacology and General. A bimonthly appearing in English since 1994, which continues “Acta Poloniae Pharmaceutica”, whose first issue appeared in December 1937. The war halted the activity of the journal’s creators. Issuance of “Acta Poloniae Pharmaceutica” was resumed in 1947. From 1947 the journal appeared irregularly, initially as a quarterly, then a bimonthly. In the years 1963 – 1973 alongside the Polish version appeared the English edition of the journal. Starting from 1974 only works in English are published in the journal. Since 1995 the journal has been appearing very regularly in two-month intervals (six books a year). The journal publishes original works from all fields of pharmacy, summaries of postdoctoral dissertations and laboratory notes.
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