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КОНТРОЛИРУЕМОЕ ВЫСВОБОЖДЕНИЕ ЧАСТИЦ, СОДЕРЖАЩИХ ДИМЕТИЛФУМАРАТ
专利权人:
СИНТОН БВ (NL)
发明人:
ХЕВЕЛ-ЯНСЕН ВАН ДЕН Коринде Аннемари (NL)
申请号:
RU2014125430/15
公开号:
RU2014125430A
申请日:
2012.11.22
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A particle or plurality of particles of dimethyl fumarate, wherein each particle is coated with at least a first coating layer comprising pharmaceutically acceptable, pH-dependent, enteric sustained polimer.2. The particle (s) according to Claim. 1, having a particle size distribution such that Dsostavlyaet from 50 to 1000 mikrometrov.3. The particle (s) according to Claim. 1 or 2, wherein the pH-dependent resistant enteric polymer represents, separately or in combination, a polymethacrylate, hydroxypropyl methylcellulose acetate succinate, hydroxypropylmethylcellulose phthalate, polyvinyl acetate phthalate, cellulose acetate phthalate or shellak.4. The particle (s) according to Claim. 1, wherein the polymer is a copolymer of methacrylic acid and methyl methacrylate copolymer or methacrylic acid and etilakrilata.5. The particle (s) according to Claim. 1, wherein the amount of polymer coating is from 10 to 100% by weight. by weight of particles or dimetilfumarata.6 particles. The particle (s) according to Claim. 1, the release capable of dimethyl fumarate, which was confirmed in USP or Ph. Eur. tests in vitro dissolution in a special basket equipment at 100 rev / min using an artificial gastric juice to measure indicators of dissolution within the first two hours of the test and artificial intestinal juice for measuring parameters of dissolution in the next hours, the results of which are as follows: - during the first two hours after start of the test was observed release max. 10% by weight. of the total dimethyl - during the first three hours of the release was observed min after starting the test. 50 wt.%, Preferably min. 60% by weight. of the total number dimetilfumarata.7. Pharmaceutical preparation for oral administration containing particle yl1. Частица или множество частиц диметилфумарата, где каждая частица покрыта как минимум первым слоем покрытия, содержащим фармацевтически приемлемый, рН-зависимый, устойчивый в кишечнике полимер.2. Частица(ы) по п. 1,
来源网站:
中国工程科技知识中心
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http://www.ckcest.cn/home/

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