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STABLE AT OXIDATION, RESISTANT TO HACKING A MEDICINAL FORM
专利权人:
ГРЮНЕНТАЛЬ ГМБХ (DE)
发明人:
БАРНШАЙД Лутц (DE),ГАЛИЯ Эрик (DE),ШВИР Зебастиан (DE),БЕРТРАМ Ульрике (DE),ГАЙССЛЕР Аня (DE),ГРИССМАНН Корнелия (DE),БАРТОЛОМЭУС Иоганнес (DE)
申请号:
RU2012106167/15
公开号:
RU2012106167A
申请日:
2010.07.21
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. A burglar resistant pharmaceutical dosage form in the form of a tablet that has a breakdown resistance of at least 300 N, thermoformable by extrusion of a hot melt mixture, which includes the pharmacologically active ingredient (A), a free physiologically acceptable polybasic carboxylic acid (B) in amount from 0.001 wt.% to 5.0 wt.% calculated on the total weight of the pharmaceutical dosage form, and is an antioxidant selected from the group comprising ascorbic acid or its salts, ascorbyl palmitate, α-tocophero l, Vitamin E-succinate, Vitamin E-palmitate, butylhydroxyanisole, butylhydroxytoluene, monothioglycerol, coniferyl benzoate, nordihydroguayaretic acid, gallic acid esters, phosphoric acid and sodium bisulfite; in an amount of from 0.001 wt.% to 5.0 wt.% in terms of the total weight of the pharmaceutical dosage form; and polyalkylene oxide (C), which has a weight average molecular weight M of at least 200,000 g / mol. 2. The pharmaceutical dosage form according to claim 1, wherein the pharmacologically active ingredient (A) is an opioid. The pharmaceutical dosage form according to claim 1 or 2, wherein the polybasic carboxylic acid is selected from the group consisting of maleic acid, fumaric acid, pentanedioic acid, malonic acid and citric acid. The pharmaceutical dosage form according to claim 1 or 2, wherein the acid content (B) is in the range of 0.005 to 2.5% by weight, based on the total weight of the pharmaceutical dosage form. The pharmaceutical dosage form according to claim 1 or 2, wherein the antioxidant is α-tocopherol. Pharmaceutical1. Устойчивая к взлому фармацевтическая лекарственная форма в форме таблетки, которая имеет сопротивление разрушению по крайней мере 300 Н, термоформируемая путем экструзии горячего расплава смеси, которая включает- фармакологически активный ингредиент (А),- свободную физиологически приемлемую многоосновную карбоновую кислоту (В) в количестве от 0,001 мас.% до 5,0 мас.% в пересчете на общую массу фармацевтической л
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中国工程科技知识中心
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