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MEDICINAL FORMS WITH IMPROVED PHARMACOKINETIC PROPERTIES
专利权人:
БАЙЕР ШЕРИНГ ФАРМА АКЦИЕНГЕЗЕЛЬШАФТ (DE)
发明人:
СЕРНО Петер (DE),ХАЙНИГ Роланд (DE),ПАУЛИ Керстин (DE),ХАЯУЧИ Ютака (DE)
申请号:
RU2011111106/15
公开号:
RU2011111106A
申请日:
2011.03.24
申请国别(地区):
RU
年份:
2012
代理人:
摘要:
1. The form of the drug, instant in the mouth, containing vardenafil, characterized in that at least 80% of the dose of vardenafil from the administered form of the substance is soluble at 25 ° C in 10 ml of physiological saline solution, and the degree of release from the form of the drug in 900 ml of physiological saline solution for the first 5 minutes in the USP apparatus for mixing, with blades, at 50 rpm, at 37 ° C is at least 70%. ! 2. The drug form according to claim 1, containing vardenafil in the form of a salt with an acid or vardenafil with an acid. ! 3. The form of the drug according to claim 2, containing vardenafil hydrochloride or vardenafil hydrochloride trihydrate. ! 4. The drug form according to claim 3, containing vardenafil hydrochloride or vardenafil hydrochloride trihydrate in micronized form with an average particle size of less than 20 microns. ! 5. The form of the drug according to one of claims 1 to 4, containing from 40% to 99% sugar alcohols. ! 6. The form of the drug according to one of claims 1 to 4 in the package, indicating on the packing slip, label or cardboard box that the form of the drug is placed in the oral cavity and is swallowed after dissolution. ! 7. The form of the drug according to claim 5 in the package, indicating on the packing slip, label or packaging cardboard box that the form of the drug is placed in the oral cavity and is swallowed after dissolution.1. Форма лекарственного средства, быстрорастворимая во рту, содержащая варденафил, отличающаяся тем, что, по меньшей мере, 80% дозы варденафила из вводимой формы вещества растворимы при 25°С в 10 мл физиологического раствора поваренной соли, и степень высвобождения из формы лекарственного средства в 900 мл физиологического раствора поваренной соли в течение первых 5 мин в аппарате USP для смешивания, с лопастями, при 50 об/мин, при 37°С составляет, по меньшей мере, 70%. ! 2. Форма лекарственного средства по п.1, содержащая варденафил в виде соли с кислотой или варден
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